Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04165057
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Other: Optimal muscle tension management	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Single Blind
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy - a Prospective Randomized Control Study
• Anticipated Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group OMT Optimal muscle tension management	Other: Optimal muscle tension management; including TOF monitor and reversal of neuromuscular blockade agent : sugammadex
No Intervention: Group Control Conventional anesthetic management

Outcome Measures

Primary Outcome Measures

1. Surgical condition [5 minutes]

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

Secondary Outcome Measures

1. Peak inspiratory pressure during surgery [1 hour]

   Peak inspiratory pressure during surgery

2. Mean blood pressure [Every 5 mins]

   Mean blood pressure during the CO2 inflation

3. Total surgical time [1 hour]

   Total surgical time

4. Total Rocuronium doses during surgery [1 hour]

   Total Rocuronium doses during surgery

5. Pain score at Postoperative room [1 hour]

   describe by 11 points Numeric rating scales (0-10). From 0 which means "no pain" to 10 means "worst pain"

6. Heart Rate [every 5 mins]

   Every beat per minutes heart rate during CO2 inflation

7. Respiratory complications [Every 5 mins]

   Record any respiratory complications including desaturations (<95%, more than 30 seconds, Rispiratory rate < 8), aspiration or airway obstruction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital, Hsin-Chu Branch	Hsinchu		Taiwan	300

Sponsors and Collaborators

• National Taiwan University Hospital Hsin-Chu Branch

Investigators

• Study Director: MING-HUI HUNG, MD, National Taiwan University Hospital Hsinchu Branch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital Hsin-Chu Branch
• ClinicalTrials.gov Identifier: NCT04165057
• Other Study ID Numbers: 108-084-F
• First Posted: Nov 15, 2019
• Last Update Posted: Nov 15, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital Hsin-Chu Branch: Laparoscopic surgery; Optimal muscle tension; Neuromuscular monitoring; Neuromuscular blockade; Sugammadex

Study Results

No Results Posted as of Nov 15, 2019