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

Phase 4

• Conditions: Profound Muscle Relaxation; Muscle Trauma; Postoperative Analgesic Demand; Postoperative Pulmonary Function
• Interventions: Drug: profound neuromuscular blockade

• Registration Number: NCT01804933
• Lead Sponsor: Ying Xiao

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Status Verified: 2013-03
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-03-04
• Last Update Submitted: 2013-03-04
• Study First Posted: 2013-03-05
• Last Update Posted: 2013-03-05
• Primary Completion: 2013-07
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
optimal neuromuscular blockade	profound neuromuscular blockade	Rocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively
profound neuromuscular blockade	profound neuromuscular blockade	Rocuronium dose will be infused to maintain a depth of NMB to PTC 1\~2 intraoperatively

Primary Outcome Measures

Name	Time	Method
degree of muscle trauma	72h postoperatively	serum CK

Secondary Outcome Measures

Name	Time	Method
postoperative analgesic requirement	7days postoperatively	consumption of morphine

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China