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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6090

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Vecuronium Bromide
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.
Drug: Cisatracurium
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.
Drug: Rocuronium
Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
Other Names:
  • Esmeron

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xiangya Hospital of Central South University
Peking Union Medical College Hospital
Shanghai Zhongshan Hospital
China Medical University Hospital
Chinese PLA General Hospital
First Affiliated Hospital, Sun Yat-Sen University
RenJi Hospital
West China Hospital
Tongji Hospital
Ruijin Hospital
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Guangzhou Medical University
Zhujiang Hospital
Eastern Hepatobiliary Surgery Hospital
Wuhan Union Hospital, China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Tianjin Medical University General Hospital
Hebei Medical University Fourth Hospital
Central South University
First Affiliated Hospital of Xinjiang Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xinmin Wu, Doctor, Peking University First Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSA-NMB-001

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings