Influence of Profound Muscle Relaxation on Muscle Trauma and Postoperative Pulmonary Function
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMarch 5, 2013
March 1, 2013
1 year
March 4, 2013
March 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
degree of muscle trauma
serum CK
72h postoperatively
Secondary Outcomes (1)
postoperative analgesic requirement
7days postoperatively
Other Outcomes (1)
postoperaive pulmonary function
3days postoperatively
Study Arms (3)
conventional neuromuscular blockade
NO INTERVENTIONNo rocuronium will be administered intraoperatively unless there is surgeons' complain or patients movement
optimal neuromuscular blockade
ACTIVE COMPARATORRocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively
profound neuromuscular blockade
EXPERIMENTALRocuronium dose will be infused to maintain a depth of NMB to PTC 1\~2 intraoperatively
Interventions
Rocuronium dose will be infused to maintain a depth of NMB to PTC 1\~2 intraoperatively
Eligibility Criteria
You may qualify if:
- ASA 1\~2,scheduled to undergo upper abdominal surgery by midline incision
You may not qualify if:
- neuromuscular disorder
- history of malignant hyperthemia
- allergy to medications used during general anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ying Xiaolead
Study Sites (1)
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Study Officials
- STUDY DIRECTOR
Ying Xiao, MD, PhD
First Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 4, 2013
First Posted
March 5, 2013
Study Start
July 1, 2012
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
March 5, 2013
Record last verified: 2013-03