Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724932
First received: July 28, 2008
Last updated: October 9, 2014
Last verified: October 2014

July 28, 2008
October 9, 2014
July 2008
April 2009   (final data collection date for primary outcome measure)
Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 [ Time Frame: From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes) ] [ Designated as safety issue: No ]
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.9. [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00724932 on ClinicalTrials.gov Archive Site
  • Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 [ Time Frame: From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes) ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
  • Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8 [ Time Frame: From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes) ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
  • Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs [ Time Frame: From signing of informed consent to end of trial (7 days after surgery) ] [ Designated as safety issue: Yes ]

    An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.

    Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.

  • Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs [ Time Frame: From signing of informed consent to end of trial (7 days after surgery) ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.
  • Neuromuscular assessments: Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.5, 0.6, 0.7 and 0.8 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
  • Neuromuscular assessments: Time from start of administration of the last dose of rocuronium to recovery of the T4/T1 ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
  • Time from start of administration of the last dose of rocuronium to the time of 1-2 PTC in the 4.0 mg.kg-1 sugammadex group. [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
  • Time from start of administration of the last dose of rocuronium to the time of reappearance of T2 in the 50 μg.kg-1 neostigmine group. [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
  • Vital signs, i.e. heart rate and blood pressure [ Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (= the day after surgery) ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: At screening and at the post-anesthetic visit ] [ Designated as safety issue: Yes ]
  • Pre-treatment (serious) events (from signing informed consent until administration of IMP) and (serious) adverse events (S)AEs [ Time Frame: From administration of IMP up to end of trial (=seven days after surgery) ] [ Designated as safety issue: Yes ]
  • TOF-Watch® SX and arm board related adverse events [ Time Frame: During anesthesia ] [ Designated as safety issue: Yes ]
  • Reoccurrence of neuromuscular blockade based on the TOF-Watch® SX recording i.e. a decline in T4/T1 ratio from >=0.9 to <0.8 in at least three consecutive TOF values [ Time Frame: During anesthesia ] [ Designated as safety issue: Yes ]
  • Clinical evidence of reoccurrence of neuromuscular blockade or residual neuromuscular blockade (routine oxygen saturation by pulse oximetry and breath frequency measurement) [ Time Frame: Until 24 h after IMP ] [ Designated as safety issue: Yes ]
  • Events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium [ Time Frame: During trial ] [ Designated as safety issue: Yes ]
  • Monitoring of Clinical signs of recovery according to routine anesthetic procedures at the trial sites [ Time Frame: No time frame: according to routine practice ] [ Designated as safety issue: Yes ]
  • Pregnancy follow up [ Time Frame: 30th postoperative day ] [ Designated as safety issue: Yes ]
  • Time from OR admission (physical placement of subject into the OR) to OR discharge ready [ Time Frame: Time from OR admission to OR discharge ready ] [ Designated as safety issue: No ]
  • Time from OR admission (physical placement of subject into the OR) to actual OR discharge [ Time Frame: Time from OR admission to actual OR discharge ] [ Designated as safety issue: No ]
  • Time from OR discharge ready to actual OR discharge [ Time Frame: Time from OR discharge ready to actual OR discharge ] [ Designated as safety issue: No ]
  • Time from start of IMP administration to tracheal extubation [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
  • Time from start of IMP administration to T4/T1 ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
  • Time from start of IMP administration to OR discharge ready [ Time Frame: Time from start of IMP administration to OR discharge ready ] [ Designated as safety issue: No ]
  • Time from start of IMP administration to actual OR discharge [ Time Frame: Time from start of IMP administration to actual OR discharge ] [ Designated as safety issue: No ]
  • Time from tracheal extubation to OR discharge ready [ Time Frame: Time from tracheal extubation to OR discharge ready ] [ Designated as safety issue: No ]
  • Time from tracheal extubation to actual OR discharge [ Time Frame: Time from tracheal extubation to actual OR discharge ] [ Designated as safety issue: No ]
  • Time from OR discharge ready to PACU discharge ready (a Modified Aldrete Score of >=9 is required for discharge from the PACU) [ Time Frame: Time from OR discharge ready to PACU discharge ready ] [ Designated as safety issue: No ]
  • Time from OR discharge ready to actual PACU discharge [ Time Frame: Time from OR discharge ready to actual PACU discharge ] [ Designated as safety issue: No ]
  • Time from actual OR discharge to PACU discharge ready (a Modified Aldrete Score of >=9 is required for discharge from the PACU) [ Time Frame: Time from actual OR discharge to PACU discharge ready ] [ Designated as safety issue: No ]
  • Time from actual OR discharge to actual PACU discharge [ Time Frame: Time from actual OR discharge to actual PACU discharge ] [ Designated as safety issue: No ]
  • Time from PACU admit to PACU discharge ready (a Modified Aldrete Score of >=9 is required for discharge from the PACU) [ Time Frame: Time from PACU admit to PACU discharge ready ] [ Designated as safety issue: No ]
  • Time from PACU admit to actual PACU discharge [ Time Frame: Time from PACU admit to actual PACU discharge ] [ Designated as safety issue: No ]
  • Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6 [ Time Frame: From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes) ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB.
  • Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 [ Time Frame: From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes) ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB.
  • Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group [ Time Frame: From last dose of rocuronium to 1-2 PTC (up to ~9 minutes) ] [ Designated as safety issue: No ]
    The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered.
  • Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group [ Time Frame: From last dose of rocuronium to reappearance of T2 (up to ~26 minutes) ] [ Designated as safety issue: No ]
    The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered.
  • Mean Systolic Blood Pressure [ Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery) ] [ Designated as safety issue: Yes ]
    Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).
  • Mean Diastolic Blood Pressure [ Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery) ] [ Designated as safety issue: Yes ]
    Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).
  • Mean Heart Rate [ Time Frame: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery) ] [ Designated as safety issue: Yes ]
    Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).
  • Number of Participants Who Had Physical Examinations [ Time Frame: At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery) ] [ Designated as safety issue: Yes ]
    Physical examinations were to be conducted at screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery).
  • Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events [ Time Frame: From induction of anesthesia to recovery from NMB (up to ~3 hours) ] [ Designated as safety issue: Yes ]
    Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user.
  • Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values) [ Time Frame: Up to 30 minutes after IMP administration ] [ Designated as safety issue: Yes ]
    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB.
  • Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement) [ Time Frame: Up to 24 hours after IMP administration ] [ Designated as safety issue: Yes ]
    Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring.
  • Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium [ Time Frame: Up to 7 days after IMP administration ] [ Designated as safety issue: Yes ]
    Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded.
  • Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites [ Time Frame: Up to PACU discharge (up to ~4.5 hours) ] [ Designated as safety issue: Yes ]
    The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site.
  • Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study [ Time Frame: Up to 30 days after IMP administration ] [ Designated as safety issue: Yes ]
    Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial.
  • Time From Operating Room Admission to Operating Room Discharge Ready [ Time Frame: From Operating Room admission to Operating Room discharge ready (up to ~3 hours) ] [ Designated as safety issue: No ]
    The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place.
  • Time From Operating Room Admission to Actual Operating Room Discharge [ Time Frame: From Operating Room admission to actual Operating Room discharge (up to ~3 hours) ] [ Designated as safety issue: No ]
    The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.
  • Time From Operating Room Discharge Ready to Actual Operating Room Discharge [ Time Frame: From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes) ] [ Designated as safety issue: No ]
    The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.
  • Time From Start of IMP Administration to T4/T1 Ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90 [ Time Frame: From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes) ] [ Designated as safety issue: No ]
    The time of IMP administration was defined as the actual time at which IMP administration was started.
  • Time From Start of IMP Administration to Tracheal Extubation [ Time Frame: From start of IMP administration to tracheal extubation (up to ~21 minutes) ] [ Designated as safety issue: No ]
    The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated.
  • Time From Start of IMP Administration to Operating Room Discharge Ready [ Time Frame: From start of IMP administration to Operating Room discharge ready (up to ~21 minutes) ] [ Designated as safety issue: No ]
    The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.
  • Time From Start of IMP Administration to Actual Operating Room Discharge [ Time Frame: From start of IMP administration to actual Operating Room discharge (up to ~26 minutes) ] [ Designated as safety issue: No ]
    The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.
  • Time From Tracheal Extubation to Operating Room Discharge Ready [ Time Frame: From tracheal extubation to Operating Room discharge ready (up to ~1 minute) ] [ Designated as safety issue: No ]
    The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.
  • Time From Tracheal Extubation to Actual Operating Room Discharge [ Time Frame: From tracheal extubation to actual OR discharge (up to ~5 minutes) ] [ Designated as safety issue: No ]
    The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.
  • Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready [ Time Frame: From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes) ] [ Designated as safety issue: No ]
    The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.
  • Time From Operating Room Discharge Ready to Actual PACU Discharge [ Time Frame: From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours) ] [ Designated as safety issue: No ]
    The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.
  • Time From Actual Operating Room Discharge to PACU Discharge Ready [ Time Frame: From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes) ] [ Designated as safety issue: No ]
    The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.
  • Time From Actual Operating Room Discharge to Actual PACU Discharge [ Time Frame: From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours) ] [ Designated as safety issue: No ]
    The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.
  • Time From PACU Admit to PACU Discharge Ready [ Time Frame: From PACU admit to PACU discharge ready (up to ~25 minutes) ] [ Designated as safety issue: No ]
    The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.
  • Time From PACU Admit to Actual PACU Discharge [ Time Frame: From PACU admit to actual PACU discharge (up to ~4.3 hours) ] [ Designated as safety issue: No ]
    The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.
Not Provided
 
Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)
A Multi-center, Randomized, Parallel-group, Comparative, Active-controlled, Safety-assessor Blinded Trial in Adult Subjects Comparing the Efficacy and Safety of Sugammadex (SCH 900616, ORG 25969) Administered at 1-2 PTC With Neostigmine Administered at Reappearance of T2 in Subjects Undergoing Laparoscopic Cholecystectomy or Appendectomy Under Propofol Anesthesia

The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in participants undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit (PACU) length of stay.

In those surgical procedures where a neuromuscular block is desired for intubation and/or avoid unwanted muscular activity, anesthesiologists may use a more profound NMB until the end of surgery, e.g. in open abdominal procedures or during laparoscopic procedures in order to improve surgical conditions. Reversal with sugammadex at a dose of 4.0 mg.kg-1 at 1-2 PTC after an intubation dose of 0.6 mg.kg-1 or maintenance dosing rocuronium has been found to be both safe and efficacious in previous clinical trials but has never been investigated exclusively in participants undergoing laparoscopic cholecystectomy or appendectomy.

With sugammadex profound muscle relaxation may now be provided right up to the end of the surgical procedure. This may lead to improved Patient Outcomes, such as improvement in the time from end of surgery to the discharge to the PACU. In this multi-center, randomized, parallel-group, active-controlled, safety-assessor blinded trial such benefits will be further investigated.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Anesthesia, General
  • Drug: Rocuronium
    Participants will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After this dose, maintenance doses of 0.1-0.2 mg.kg-1 rocuronium may be given.
    Other Names:
    • rocuronium bromide
    • Esmeron®
  • Drug: Sugammadex
    After the last dose of rocuronium has been administered, participants will receive, according to the randomization, a single bolus dose of 4.0 mg.kg-1 sugammadex at 1-2 PTC.
    Other Names:
    • Org 25969
    • SCH 900616
    • MK-8616
    • Bridion®
  • Drug: Neostigmine
    After the last dose of rocuronium has been administered, participants will receive, according to the randomization, 50 μg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.
    Other Name: Prostigmin®
  • Drug: Atropine
    After the last dose of rocuronium has been administered, participants will receive, according to randomization, 10 μg.kg-1 atropine (with neostigmine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.
    Other Name: atropine sulfate
  • Experimental: Sugammadex
    4.0 mg.kg-1 sugammadex at 1-2 PTC
    Interventions:
    • Drug: Rocuronium
    • Drug: Sugammadex
  • Experimental: Neostigmine
    50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
    Interventions:
    • Drug: Rocuronium
    • Drug: Neostigmine
    • Drug: Atropine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
May 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants of American Society of Anesthesiologists class 1-3
  • Participants of age above or equal to the age of 18 years
  • Participants who are scheduled to undergo a laparoscopic cholecystectomy or appendectomy under general anesthesia requiring neuromuscular relaxation with rocuronium, and if applicable, maintenance of neuromuscular blockade
  • Participants who have given written informed consent

Exclusion Criteria:

  • Participants in whom a difficult intubation because of anatomical malformations is expected
  • Participants known or suspected to have neuromuscular disorders affecting NMB
  • Participants known or suspected to have a significant renal dysfunction
  • Participants known or suspected to have a severe hepatic dysfunction
  • Participants known or suspected to have (family) history of malignant hyperthermia
  • Participants known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
  • Participants in whom the use of neostigmine and/or atropine is contraindicated
  • Female participants who are pregnant (pregnancy will be excluded for women both from medical history and by a human chorionic gonadotropin (hCG) test within 24h before surgery, except for women who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy)
  • Female participants who are breast-feeding
  • Participants who participated in another clinical trial not pre-approved by the sponsor, within 30 days of entering into trial 19.4.318 (P05699)
  • Participants who have already participated in a sugammadex trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00724932
P05699, 19.4.318, MK-8616-002, 2007-007951-14
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP