A Study of Residual Curarization Incidence in China

Phase 4

• Conditions: Perioperative/Postoperative Complications; PORC (Postoperative Residual Curarization)
• Interventions: Drug: Vecuronium Bromide; Drug: Cisatracurium; Drug: Rocuronium

• Registration Number: NCT01690338
• Lead Sponsor: Peking University First Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Study Start: 2012-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-24
• Primary Completion: 2014-10
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6090

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vecuronium Bromide	Vecuronium Bromide	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.
cisatracurium	Cisatracurium	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.
rocuronium	Rocuronium	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.

Primary Outcome Measures

Name	Time	Method
incidence of TOFr<0.9	From tracheal extubation to 1 minute after extubation	Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.

Secondary Outcome Measures

Name	Time	Method
Incidence of TOFr<0.9	One minute after arriving at PACU	When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately
Incidence of TOFr<0.7	One minute after arriving at PACU	When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately

Trial Locations

Locations (22)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Zhujiang Hospital Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Hebei Medical University Fourth Hospital; 🇨🇳 Shijiazhuang, Hebei, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College of HUST; 🇨🇳 Wuhan, Hubei, China

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

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