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

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ClinicalTrials.gov Identifier: NCT01804933
Recruitment Status : Unknown
Verified March 2013 by Ying Xiao, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Ying Xiao, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Profound Muscle Relaxation Muscle Trauma Postoperative Analgesic Demand Postoperative Pulmonary Function Drug: profound neuromuscular blockade Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : August 2013

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U.S. FDA Resources

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



Primary Outcome Measures :
  1. degree of muscle trauma [ Time Frame: 72h postoperatively ]
    serum CK


Secondary Outcome Measures :
  1. postoperative analgesic requirement [ Time Frame: 7days postoperatively ]
    consumption of morphine


Other Outcome Measures:
  1. postoperaive pulmonary function [ Time Frame: 3days postoperatively ]
    FEV1 FVC PEF



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804933


Contacts
Contact: Ying Xiao, MD,PhD 13570521662 xying2603@163.com

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Principal Investigator: Ying Xiao, MD,PhD         
Sponsors and Collaborators
Ying Xiao
Investigators
Study Director: Ying Xiao, MD, PhD First Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Ying Xiao, Associate Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01804933     History of Changes
Other Study ID Numbers: 伦审[2012]326号
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Ying Xiao, First Affiliated Hospital, Sun Yat-Sen University:
profound muscle relaxation
muscle trauma
postoperative analgesic demand
postoperative pulmonary function

Additional relevant MeSH terms:
Wounds and Injuries
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs