A Study of Residual Curarization Incidence in China

Study Overview
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Brief Summary
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The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.

Detailed Description
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In the last twenty years, residual curarization in PACU (Post Anesthesia Care Unit) has become a common problem in clinical practice and poses high risk to patients. The residual curarization incidence of Neuromuscular blocking agents (NMBA) varies very much between different studies. These differences indicates the necessity of further study. In China, there is no common view of the harmfulness of residual curarization and its complications. The consensus on the necessity of neuromuscular transmission monitoring and neuromuscular blockade antagonist has not been reached yet. There is also no similar large-scale survey in China. In this case, the investigators conduct this large scale multicentre study, which is designed to learn the incidence of residual curarization and its complications. Further analysis of risk factors will also been made. All these efforts are hoped to fill the data gap and provide reliable evidences for rational use of NMBA.

Official Title
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A Perspective, Multicentre, Randomized，Blind Study of Residual Curarization Incidence in China

Conditions
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Perioperative/Postoperative Complications, PORC (Postoperative Residual Curarization)

Intervention / Treatment
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* Drug: Vecuronium Bromide
* Drug: Rocuronium
* Drug: Cisatracurium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or older Nondepolarized NMBA will be given during surgery and tracheal extubation will be performed after surgery Willing to comply with all study procedures and provide signed and dated informed consent Exclusion Criteria: Allergic reaction to gel electrode Neuromuscular disorders and hepatic or renal dysfunction Scheduled to receive mechanical ventilation therapy Involved in other clinical trials Body position and surgical procedure affecting TOF-Watch SX normal function

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vecuronium Bromide<br>Patients who will be performed general anesthesia and tracheal intubation. Vecuronium will be used during surgery and tracheal extubation is scheduled when surgery is over. | Drug: Vecuronium Bromide<br>* Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.<br>* Other names: Norcuron;|
| Active Comparator: cisatracurium<br>Patients who will be performed general anesthesia and tracheal intubation. Cisatracurium will be used during surgery and tracheal extubation is scheduled when surgery is over. | Drug: Cisatracurium<br>* Administrative protocol of cisatracurium is determined by each caregiver's clinical experience<br>* Other names: Nimbex;|
| Active Comparator: rocuronium<br>Patients who will be performed general anesthesia and tracheal intubation. Rocuronium will be used during surgery and tracheal extubation is scheduled when surgery is over. | Drug: Rocuronium<br>* Administrative protocol of rocuronium is determined by each caregiver's clinical experience.<br>* Other names: Esmeron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of TOFr<0.9 | Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately. | From tracheal extubation to 1 minute after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of TOFr<0.9 | When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately | One minute after arriving at PACU | 
| Incidence of TOFr<0.7 | Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately. | From tracheal extubation to 1 minute after extubation | 
| Incidence of TOFr<0.7 | When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately | One minute after arriving at PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TOFr (train of four ratio), airway extubation, PACU (postanesthesia care unit), PORC (postoperative residual curarization)