Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed)

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Other: Neuromuscular Blocking Agent (NMBA)

• Registration Number: NCT01181349
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia. During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital discharge data from the participants will be collected. The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2012-02-29
• Results First Submitted QC: 2012-02-29
• Results First Posted: 2012-04-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• 18 years of age or older
• Informed consent signed
• Admission for elective surgery
• Administration of nondepolarizing NMBAs during surgery

Exclusion Criteria

• Admission for emergency surgery
• Reoperation on the same hospital admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
P07535 study participants with a TOF ratio <0.9	Neuromuscular Blocking Agent (NMBA)	Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio \<0.9 at PACU arrival.
P07535 study participants with a TOF ratio ≥0.9	Neuromuscular Blocking Agent (NMBA)	Participants enrolled in the P07535 study who are included in the primary outcome measurement, which is defined as the incidence of postoperative residual neuromuscular blockade, who had a TOF ratio ≥0.9 at PACU arrival.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival	Upon arrival in the PACU	The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio \<0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events	From end of surgery through hospital discharge, an expected average of 6 days
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents	From start of surgery through PACU arrival	Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents	From end of surgery through PACU arrival, an expected average of 10 minutes	Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane	From start of surgery through PACU arrival	Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.