Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy

NCT ID: NCT04165057

Last Updated: 2019-11-15

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

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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Our study is intended to compare optimal muscle tension management or conventional anesthetic management in laparoscopic cholecystectomy about surgical condition during the surgery and other conditions after surgery at POR.

Detailed Description

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This study is intended to recruit 70 patients undergoing laparoscopic cholecystectomy, whom will be randomized to receive optimal muscle tension management or conventional anesthetic management without optimal muscle tension management. Our primary hypothesis is that optimal muscle tension management provides improved surgical conditions and less intra-abdominal pressure required. The secondary endpoints include surgical duration, intraoperative complications, total amount of muscle relaxants, respiratory and hemodynamic changes during surgery, extubation time and any events during post-anesthetic recovery.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Single Blind

Study Groups

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Group OMT

Optimal muscle tension management

Group Type ACTIVE_COMPARATOR

Optimal muscle tension management

Intervention Type OTHER

including TOF monitor and reversal of neuromuscular blockade agent : sugammadex

Group Control

Conventional anesthetic management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Optimal muscle tension management

including TOF monitor and reversal of neuromuscular blockade agent : sugammadex

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 20\~80 years old
* ASA score : 1-2
* Regular laparoscopic cholecystectomy

Exclusion Criteria

* Renal function impairement (eGFR \< 60 ml/min/1.73m2) or ESRD
* BMI \< 18.5 kg/m2 or \>30 kg/m2
* History of other abdominal surgery
* Allergy to rocuronium, cisatracurium, neostigmine or sugammadex
* Emergent surgery
* Convert to open cholecystectomy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MING-HUI HUNG, MD

Role: STUDY_DIRECTOR

National Taiwan University Hospital Hsinchu Branch

Locations

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National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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YI-PING WANG, MD

Role: CONTACT

+886-3-5326151 ext. 3900

Facility Contacts

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YI-PING WANG, MD

Role: primary

+886-3-5326151 ext. 3900

Other Identifiers

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108-084-F

Identifier Type: -

Identifier Source: org_study_id

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