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

• Sponsor: Ying Xiao (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01804933
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 3
• Duration (Months): 13
• Patients Per Site Per Month: 5.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Profound Muscle Relaxation; Muscle Trauma; Postoperative Analgesic Demand; Postoperative Pulmonary Function	Drug: profound neuromuscular blockade	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2012
• Anticipated Primary Completion Date: Jul 1, 2013
• Anticipated Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: profound neuromuscular blockade; Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively
Experimental: profound neuromuscular blockade Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively	Drug: profound neuromuscular blockade; Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively

Outcome Measures

Primary Outcome Measures

1. degree of muscle trauma [72h postoperatively]

   serum CK

Secondary Outcome Measures

1. postoperative analgesic requirement [7days postoperatively]

   consumption of morphine

Other Outcome Measures

1. postoperaive pulmonary function [3days postoperatively]

   FEV1 FVC PEF

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Ying Xiao

Investigators

• Study Director: Ying Xiao, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ying Xiao, Associate Professor, First Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT01804933
• Other Study ID Numbers: 伦审[2012]326号
• First Posted: Mar 5, 2013
• Last Update Posted: Mar 5, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Ying Xiao, Associate Professor, First Affiliated Hospital, Sun Yat-Sen University: profound muscle relaxation; muscle trauma; postoperative analgesic demand; postoperative pulmonary function
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Mar 5, 2013