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

Study Overview
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Brief Summary
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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.

Official Title
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Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Other: Neuromuscular Blocking Agent (NMBA)
* Other: Neuromuscular Blocking Agent (NMBA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| P07535 study participants with a TOF ratio <0.9<br>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. | Other: Neuromuscular Blocking Agent (NMBA)<br>* While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.<br>|
| P07535 study participants with a TOF ratio ≥0.9<br>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. | Other: Neuromuscular Blocking Agent (NMBA)<br>* While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival | 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). | Upon arrival in the PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents | 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. | From start of surgery through PACU arrival | 
| Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane | 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. | From start of surgery through PACU arrival | 
| Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents | 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. | From end of surgery through PACU arrival, an expected average of 10 minutes | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuromuscular blockade; general anesthesia