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

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.

  • 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
  • Study Primary Completion Date: July 2013

Interventions Used in this Clinical Trial

  • Drug: profound neuromuscular blockade
    • Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively

Arms, Groups and Cohorts in this Clinical Trial

  • 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
  • Experimental: profound neuromuscular blockade
    • Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively

Outcome Measures for this Clinical Trial

Primary Measures

  • degree of muscle trauma
    • Time Frame: 72h postoperatively
      Safety Issue?: No

Secondary Measures

  • postoperative analgesic requirement
    • Time Frame: 7days postoperatively
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Ying Xiao
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ying Xiao, Associate Professor – First Affiliated Hospital, Sun Yat-Sen University
  • Overall Official(s)
    • Ying Xiao, MD, PhD, Study Director, First Affiliated Hospital, Sun Yat-Sen University
  • Overall Contact(s)
    • Ying Xiao, MD,PhD, 13570521662, xying2603@163.com

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01804933