Residual Curarization and Its Incidence at Tracheal Extubation (P08194)

NCT01318382 | Completed Phase 4 Results

• 2 other identifiers: P08194MK-8616-063
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Observation of Neuromuscular Block

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of 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.

  Up to 1 minute prior to tracheal extubation

Secondary Outcomes (3)

• Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)

  Up to 2 minutes prior to PACU arrival

• 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

  Up to 1 minute prior to tracheal extubation

• 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

  Up to 2 minutes prior to PACU arrival

Study Arms (1)

TOF-Watch SX®

EXPERIMENTAL

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

Interventions

TOF-Watch SX® Monitoring of NMB DEVICE

Participants will have the extent of NMB monitored by a TOF-Watch SX®.

TOF-Watch SX®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.

  PMID: 25902322 RESULT

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 9, 2017
• Results First Posted: May 22, 2013

Record last verified: 2017-05