NCT04165057

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

November 3, 2019

Last Update Submit

November 14, 2019

Conditions

Anesthesia

Keywords

Laparoscopic surgeryOptimal muscle tensionNeuromuscular monitoringNeuromuscular blockadeSugammadex

Outcome Measures

Primary Outcomes (1)

  • Surgical condition

    Surgeon describe CO2 inflation condition by 4 point King Score (1-4). 1. excellent 2. good 3. acceptable 4. poor or unacceptable

    5 minutes

Secondary Outcomes (7)

  • Peak inspiratory pressure during surgery

    1 hour

  • Mean blood pressure

    Every 5 mins

  • Total surgical time

    1 hour

  • Total Rocuronium doses during surgery

    1 hour

  • Pain score at Postoperative room

    1 hour

  • +2 more secondary outcomes

Study Arms (2)

Group OMT

ACTIVE COMPARATOR

Optimal muscle tension management

Other: Optimal muscle tension management

Group Control

NO INTERVENTION

Conventional anesthetic management

Interventions

Optimal muscle tension managementOTHER

including TOF monitor and reversal of neuromuscular blockade agent : sugammadex

Group OMT

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

Study Officials

  • MING-HUI HUNG, MD

    National Taiwan University Hospital Hsinchu Branch

    STUDY DIRECTOR

Central Study Contacts

YI-PING WANG, MD

CONTACT

+886-3-5326151joesph0502@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2019

First Posted

November 15, 2019

Study Start

January 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)