Residual Curarization and Its Incidence at Tracheal Extubation (P08194) (RECITE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01318382
First received: March 17, 2011
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.


Condition Intervention Phase
Observation of Neuromuscular Block
Device: TOF-Watch SX® Monitoring of NMB
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Residual Curarization and Its Incidence at Tracheal Extubation

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation [ Time Frame: Up to 1 minute prior to tracheal extubation ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) 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 NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.


Secondary Outcome Measures:
  • Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU) [ Time Frame: Up to 2 minutes prior to PACU arrival ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) 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 NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.

  • Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation [ Time Frame: Up to 1 minute prior to tracheal extubation ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) 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 NMB, with a higher ratio indicating greater recovery from NMB.

  • Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU [ Time Frame: Up to 2 minutes prior to PACU arrival ] [ Designated as safety issue: No ]
    Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) 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 NMB, with a higher ratio indicating greater recovery from NMB.


Enrollment: 302
Study Start Date: June 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOF-Watch SX®
Participants who have undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
Device: TOF-Watch SX® Monitoring of NMB
Participants will have the extent of NMB monitored by a TOF-Watch SX®.

Detailed Description:

This is an observational cohort study with a device intervention to determine in which cohort the subject is falling.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be American Society of Anesthesia (ASA) class 1-3.
  • Participant must be scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours.
  • Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade.
  • Extubation must occur in the operating room (OR).

Exclusion Criteria:

  • Surgery re-admission on the same hospital admission.
  • Pre-established need for or expected to require post-operative mechanical ventilation.
  • Conditions, surgical procedures or position that may interfere with the TOF-Watch SX® operation, calibration or accuracy.
  • Administration of sugammadex (Bridion®) for reversal of neuromuscular blockade.
  • Participation in any other clinical trial.
  • Member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial.
  • Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01318382     History of Changes
Other Study ID Numbers: P08194, MK-8616-063
Study First Received: March 17, 2011
Results First Received: April 4, 2013
Last Updated: September 3, 2014
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on October 22, 2014