Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuromuscular Blockade
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 350
- Primary Endpoint
- Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival
Time Frame: 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 Outcomes
- 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)
- 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)
- Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane(From start of surgery through PACU arrival)