A Study of Residual Curarization Incidence in China

May 22, 2013 updated by: Xinmin Wu, Peking University First Hospital

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

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

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

6090

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Principal Investigator:
          • Yuan Zeng, Doctor
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Chinese PLA General hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Qinglong Dong, Doctor
          • Phone Number: 13602837397
          • Email: qldong@163.net
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • First Affiliated Hospital, Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhujiang Hospital Southern Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • Hebei Medical University Fourth Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital, Tongji Medical College of HUST
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410000
        • Recruiting
        • The second Xiangya Hospital of Central South University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • China Medical University Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Renji Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai First People's Hospital
        • Contact:
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
    • Xinjiang
      • Urumchi, Xinjiang, China, 830000
        • Withdrawn
        • The First Teaching Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
Other Names:
  • Norcuron
Active Comparator: 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.
Administrative protocol of cisatracurium is determined by each caregiver's clinical experience
Other Names:
  • Nimbex
Active Comparator: 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.
Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
Other Names:
  • Esmeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of TOFr<0.9
Time Frame: 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.
From tracheal extubation to 1 minute after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of TOFr<0.9
Time Frame: 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
One minute after arriving at PACU
Incidence of TOFr<0.7
Time Frame: 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.
From tracheal extubation to 1 minute after extubation
Incidence of TOFr<0.7
Time Frame: 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
One minute after arriving at PACU

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
any sign of residual curarization (listed in description below)
Time Frame: First 24h after surgery

Sign of residual curarization :

  1. dyspnea
  2. weak hand-grip force
  3. Head lift or leg lift time shorter than 5s
  4. aspiration
  5. respiratory rate >20/min
  6. hypoxemia (SpO2<90% when O2>3L/min)
First 24h after surgery
pulmonary complications (See description)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of one week

pulmonary complications

  1. pneumonia
  2. pulmonary atelectasis
  3. mechanical ventilation required
participants will be followed for the duration of hospital stay, an expected average of one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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