Trial Outcomes & Findings for Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed) (NCT NCT01181349)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

350 participants

Primary outcome timeframe

Upon arrival in the PACU

Results posted on

2015-10-14

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents
Overall Study STARTED	350
Overall Study COMPLETED	350
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=350 Participants Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents
Age, Continuous	54.3 years STANDARD_DEVIATION 15.9 • n=5 Participants
Sex: Female, Male Female	216 Participants n=5 Participants
Sex: Female, Male Male	134 Participants n=5 Participants

PRIMARY outcome

Timeframe: Upon arrival in the PACU

Population: Full analysis set (FAS) population includes all treated participants

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).

Outcome measures

Outcome measures
Measure	All Participants n=350 Participants Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents	P07535 Study Participants With a TOF Ratio ≥0.9 Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival	91 participants	—

SECONDARY outcome

Timeframe: From start of surgery through PACU arrival

Population: FAS population includes all treated participants; for this outcome measure only participants who received atracurium, cisatracurium, rocuronium or vecuronium are included

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.

Outcome measures

Outcome measures
Measure	All Participants n=87 Participants Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents	P07535 Study Participants With a TOF Ratio ≥0.9 n=250 Participants Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents Participants Receiving Atracurium	13 participants	42 participants
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents Participants Receiving Cisatracurium	35 participants	73 participants
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents Participants Receiving Rocuronium	31 participants	118 participants
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents Participants Receiving Vecuronium	8 participants	17 participants

SECONDARY outcome

Timeframe: From start of surgery through PACU arrival

Population: FAS population includes all treated participants; for this outcome measure only participants who received propofol or sevoflurane are included

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.

Outcome measures

Outcome measures
Measure	All Participants n=64 Participants Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents	P07535 Study Participants With a TOF Ratio ≥0.9 n=193 Participants Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane Participants Receiving Propofol	60 participants	169 participants
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane Participants Receiving Sevoflurane	4 participants	24 participants

SECONDARY outcome

Timeframe: From end of surgery through PACU arrival, an expected average of 10 minutes

Population: FAS population includes all treated participants

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.

Outcome measures

Outcome measures
Measure	All Participants n=91 Participants Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents	P07535 Study Participants With a TOF Ratio ≥0.9 n=259 Participants Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents	71 participants	162 participants

SECONDARY outcome

Timeframe: From end of surgery through hospital discharge, an expected average of 6 days

Population: FAS population includes all treated participants

Outcome measures

Outcome measures
Measure	All Participants n=91 Participants Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents	P07535 Study Participants With a TOF Ratio ≥0.9 n=259 Participants Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events	12 participants	21 participants

Adverse Events

All Participants

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=350 participants at risk Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents
Respiratory, thoracic and mediastinal disorders respiratory insufficiency	0.29% 1/350 • Number of events 1
Gastrointestinal disorders peritoneal haemorrhage	0.29% 1/350 • Number of events 1
Infections and infestations septic shock	0.29% 1/350 • Number of events 1
Respiratory, thoracic and mediastinal disorders acute respiratory distress syndrome	0.29% 1/350 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator may not publish/publicly present interim results without prior consent of Sponsor. Any materials that report results of the study must be sent to Sponsor 45 days prior to submission for publication/presentation. Sponsor has right to review and comment. In case of any disagreements concerning appropriateness of the materials, investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues or disagreement, prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER