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

NCT ID: NCT01804933

Last Updated: 2013-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Profound Muscle Relaxation Muscle Trauma Postoperative Analgesic Demand Postoperative Pulmonary Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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conventional neuromuscular blockade

No rocuronium will be administered intraoperatively unless there is surgeons' complain or patients movement

Group Type NO_INTERVENTION

No interventions assigned to this group

optimal neuromuscular blockade

Rocuronium dose will be infused to maintain depth of NMB at TOF count 1 intraoperatively

Group Type ACTIVE_COMPARATOR

profound neuromuscular blockade

Intervention Type DRUG

Rocuronium dose will be infused to maintain a depth of NMB to PTC 1\~2 intraoperatively

profound neuromuscular blockade

Rocuronium dose will be infused to maintain a depth of NMB to PTC 1\~2 intraoperatively

Group Type EXPERIMENTAL

profound neuromuscular blockade

Intervention Type DRUG

Rocuronium dose will be infused to maintain a depth of NMB to PTC 1\~2 intraoperatively

Interventions

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profound neuromuscular blockade

Rocuronium dose will be infused to maintain a depth of NMB to PTC 1\~2 intraoperatively

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ying Xiao

OTHER

Sponsor Role lead

Responsible Party

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Ying Xiao

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ying Xiao, MD, PhD

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Xiao, MD,PhD

Role: CONTACT

13570521662

Other Identifiers

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伦审[2012]326号

Identifier Type: -

Identifier Source: org_study_id

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