Back to resultsInfluence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function
Primary Purpose
Profound Muscle Relaxation, Muscle Trauma, Postoperative Analgesic Demand
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
profound neuromuscular blockade
Sponsored by
About this trial
This is an interventional treatment trial for Profound Muscle Relaxation focused on measuring profound muscle relaxation, muscle trauma, postoperative analgesic demand, postoperative pulmonary function
Eligibility 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
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
conventional neuromuscular blockade
optimal neuromuscular blockade
profound neuromuscular blockade
Arm Description
No rocuronium will be administered intraoperatively unless there is surgeons' complain or patients movement
Rocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively
Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively
Outcomes
Primary Outcome Measures
degree of muscle trauma
serum CK
Secondary Outcome Measures
postoperative analgesic requirement
consumption of morphine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01804933
Brief Title
Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ying Xiao
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Profound Muscle Relaxation, Muscle Trauma, Postoperative Analgesic Demand, Postoperative Pulmonary Function
Keywords
profound muscle relaxation, muscle trauma, postoperative analgesic demand, postoperative pulmonary function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional neuromuscular blockade
Arm Type
No Intervention
Arm Description
No rocuronium will be administered intraoperatively unless there is surgeons' complain or patients movement
Arm Title
optimal neuromuscular blockade
Arm Type
Active Comparator
Arm Description
Rocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively
Arm Title
profound neuromuscular blockade
Arm Type
Experimental
Arm Description
Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively
Intervention Type
Drug
Intervention Name(s)
profound neuromuscular blockade
Intervention Description
Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively
Primary Outcome Measure Information:
Title
degree of muscle trauma
Description
serum CK
Time Frame
72h postoperatively
Secondary Outcome Measure Information:
Title
postoperative analgesic requirement
Description
consumption of morphine
Time Frame
7days postoperatively
Other Pre-specified Outcome Measures:
Title
postoperaive pulmonary function
Description
FEV1 FVC PEF
Time Frame
3days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Xiao, MD,PhD
Phone
13570521662
Email
xying2603@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Xiao, MD, PhD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Xiao, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function
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