Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function

March 4, 2013 updated by: Ying Xiao

Although deep anesthesia can produce skeleton muscle relaxation,unnecessary deep anesthesia often had adverse cardiac effects and was related to 2-year mortality in cancer patients.The use of muscle relaxants allowed the depth of anesthesia to be optimized.However, for many anesthesiologists,in fear of residual postoperative neuromuscular blockade,intraoprative administration of muscle relaxants had to be minimized in spite of poor surgical conditions.

This study, however, is designed to test the hypothesis that profound neuromusclular blockade reduces muscle trauma caused by self-retaining retractor and thus cut down postoperative analgesic requirement.On the other hand,profound muscle relaxation can decrease postoperative diaphragmatic dysfunction and abdominal muscle trauma, which can improve postoperative pulmonary function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1~2,scheduled to undergo upper abdominal surgery by midline incision

Exclusion Criteria:

  • neuromuscular disorder
  • history of malignant hyperthemia
  • allergy to medications used during general anesthesia

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: conventional neuromuscular blockade
No rocuronium will be administered intraoperatively unless there is surgeons' complain or patients movement
Active Comparator: optimal neuromuscular blockade
Rocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively
Drug: profound neuromuscular blockade
Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively
Experimental: profound neuromuscular blockade
Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively
Drug: profound neuromuscular blockade
Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of muscle trauma
Time Frame: 72h postoperatively
serum CK
72h postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesic requirement
Time Frame: 7days postoperatively
consumption of morphine
7days postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperaive pulmonary function
Time Frame: 3days postoperatively
FEV1 FVC PEF
3days postoperatively

Collaborators and Investigators

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

Sponsor

Ying Xiao

Investigators

  • Study Director: Ying Xiao, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

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

July 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 伦审[2012]326号

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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