Residual Curarization and Its Incidence at Tracheal Extubation (P08194)

Observation of Neuromuscular Block Clinical Trial

— RECITE  

Official title:

Residual Curarization and Its Incidence at Tracheal Extubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318382
• Other study ID #: P08194
• Secondary ID: MK-8616-063
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2011
• Last updated: May 8, 2017
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• 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®.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)	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.	Up to 2 minutes prior to PACU arrival
Secondary	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	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.	Up to 1 minute prior to tracheal extubation
Secondary	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	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.	Up to 2 minutes prior to PACU arrival