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.

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
• Allocation: N/A
• 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
• Actual Primary Completion Date: May 2012
• Actual 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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).

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications of Results:

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.

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