Residual Curarization and Its Incidence at Tracheal Extubation in China (RECITE-China)

November 9, 2015 updated by: Xinmin Wu
This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-site, anesthesiologist and PACU nurse TOF-Watch SX® blinded observational study of surgical patients undergoing elective laparoscopic or open abdominal procedures requiring general anesthesia and non-depolarizing neuromuscular blockade. There are two temporal aspects to the data collection: a prospective data collection in the OR and PACU; and a retrospective chart review one week after hospital discharge.

Study Type

Observational

Enrollment (Actual)

1571

Contacts and Locations

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

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General hospital
      • Beijing, China
        • Beijing Tongren Hospital
      • Beijing, China
        • Peking University Third Hospital
      • Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China
        • Peking University People's Hospital
      • Chongqing, China
        • First Affiliated Hospital of Chongqing Medical University
      • Shanghai, China
        • Shanghai First People's Hospital
      • Shanghai, China
        • Ruijin Hospital
      • Shanghai, China
        • RenJi hospital
      • Shanghai, China
        • Shanghai Cancer Hospital, China
      • Shanghai, China
        • Shanghai Zhongshan Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China
        • Zhujiang Hospital of Southern Medical University
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital, Tongji Medical College of HUST
      • Wuhan, Hubei, China
        • Wuhan Union Hospital
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Yangzhou, Jiangsu, China
        • Northern Jiangsu Province People's Hospital
    • Jilin
      • Changchun, Jilin, China
        • China-Japan Union Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
    • Shanxi
      • Xi'an, Shanxi, China
        • Xijing Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan University
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Xinjiang Traditional Chinese Medicine Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, China
        • First Affiliated Hospital of Zhejiang University
      • Wenzhou, Zhejiang, China
        • Second Affiliated Hospital of Wenzhou Medical College

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults 18 years of age or older scheduled to undergo an elective open abdominal or laparoscopic surgical procedure for an anticipated duration of less than four hours will be approached for participation in the study.

Description

Inclusion Criteria:

  • Age≥18;
  • American Society of Anesthesiologists(ASA) class 1-3;
  • Scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours;
  • Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade;
  • Planned for extubation to occur in the OR;
  • Signed informed consent.

Exclusion Criteria:

  • Redo surgery on the same hospital admission;
  • Pre-established need or expected to require post-operative mechanical ventilation;
  • Conditions, surgical procedures, or participant positioning that may interfere with TOF-Watch SX® operation, calibration, or accuracy;
  • Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method);
  • Pregnancy;
  • Participation in any other clinical trial;
  • Member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation
Time Frame: Immediately prior to tracheal extubation in the OR
Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
Immediately prior to tracheal extubation in the OR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)
Time Frame: Immediately upon PACU arrival
Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
Immediately upon PACU arrival
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation
Time Frame: Immediately prior to tracheal extubation in the OR
Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB
Immediately prior to tracheal extubation in the OR
Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU
Time Frame: Immediately upon PACU Arrival
Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.
Immediately upon PACU Arrival

Collaborators and Investigators

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

Sponsor

Xinmin Wu

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Xinmin Wu, MD, 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

December 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LCE50498

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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