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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Ying Xiao, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01804933
First received: March 4, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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 Intervention Phase
Profound Muscle Relaxation
Muscle Trauma
Postoperative Analgesic Demand
Postoperative Pulmonary Function
Drug: profound neuromuscular blockade
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • degree of muscle trauma [ Time Frame: 72h postoperatively ] [ Designated as safety issue: No ]
    serum CK


Secondary Outcome Measures:
  • postoperative analgesic requirement [ Time Frame: 7days postoperatively ] [ Designated as safety issue: No ]
    consumption of morphine


Other Outcome Measures:
  • postoperaive pulmonary function [ Time Frame: 3days postoperatively ] [ Designated as safety issue: No ]
    FEV1 FVC PEF


Estimated Enrollment: 72
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 4, 2013
Last Updated: March 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014