We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01318382
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : May 22, 2013
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Observation of Neuromuscular Block Device: TOF-Watch SX® Monitoring of NMB Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Residual Curarization and Its Incidence at Tracheal Extubation
Study Start Date : June 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012
Arms and Interventions

Arm Intervention/treatment
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®.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01318382     History of Changes
Other Study ID Numbers: P08194
MK-8616-063 ( Other Identifier: Merck Protocol ID )
First Posted: March 18, 2011    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: May 9, 2017
Last Verified: May 2017