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

Muscle Trauma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01804933
• Other study ID #: ??[2012]326?
• Status: Recruiting
• Phase: Phase 4
• First received: March 4, 2013
• Last updated: March 4, 2013
• Start date: July 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2013
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Ying Xiao, MD,PhD
• Phone: 13570521662
• Email: xying2603[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Muscle Trauma
• Postoperative Analgesic Demand
• Postoperative Pulmonary Function
• Profound Muscle Relaxation

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Ying Xiao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperaive pulmonary function	FEV1 FVC PEF	3days postoperatively	No
Primary	degree of muscle trauma	serum CK	72h postoperatively	No
Secondary	postoperative analgesic requirement	consumption of morphine	7days postoperatively	No