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

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: March 17, 2011
• First Posted Date: March 18, 2011
• Results First Submitted Date: April 4, 2013
• Results First Posted Date: May 22, 2013
• Last Update Posted Date: May 9, 2017
• Study Start Date: June 2011
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2013)

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.

• Original Primary Outcome Measures (submitted: March 17, 2011): Incidence of residual blockade (TOF ratio <0.9) at time of tracheal extubation. [ Time Frame: Up to 10 minutes ]

Current Secondary Outcome Measures (submitted: April 4, 2013)

• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: March 17, 2011)

• Incidence of residual blockade (TOF ratio <0.9) upon arrival to the post-anesthesia care unit (PACU [ Time Frame: Up to 30 minutes ]
• Incidences of residual blockade at various TOF ratios (<0.6, ≥ 0.6 - <0.7, ≥ 0.7 - <0.8, ≥0.8 - <0.9) at tracheal extubation and upon arrival to the PACU [ Time Frame: Up to 30 minutes ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Residual Curarization and Its Incidence at Tracheal Extubation (P08194)
• Official Title: Residual Curarization and Its Incidence at Tracheal Extubation
• 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.
• Detailed Description: This is an observational cohort study with a device intervention to determine in which cohort the subject is falling.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Observation of Neuromuscular Block

Intervention

Device: TOF-Watch SX® Monitoring of NMB

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

Study Arms

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®.

Intervention: Device: TOF-Watch SX® Monitoring of NMB

• Publications *: Fortier LP, McKeen D, Turner K, de Médicis É, 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 15, 2012): 302
• Original Estimated Enrollment (submitted: March 17, 2011): 300
• Actual Study Completion Date: May 2012
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Canada

Administrative Information

• NCT Number: NCT01318382
• Other Study ID Numbers: P08194; MK-8616-063 ( Other Identifier: Merck Protocol ID )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: May 2017