Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy

Anesthesia Clinical Trial

Official title:

Efficacy and Safety of Optimal Muscle Tension Management During Laparoscopic Cholecystectomy - a Prospective Randomized Control Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04165057
• Other study ID #: 108-084-F
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2019
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: YI-PING WANG, MD
• Phone: +886-3-5326151
• Email: joesph0502[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• Optimal muscle tension management
including TOF monitor and reversal of neuromuscular blockade agent : sugammadex

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Hsin-Chu Branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical condition	Surgeon describe CO2 inflation condition by 4 point King Score (1-4).; excellent; good; acceptable; poor or unacceptable	5 minutes
Secondary	Peak inspiratory pressure during surgery	Peak inspiratory pressure during surgery	1 hour
Secondary	Mean blood pressure	Mean blood pressure during the CO2 inflation	Every 5 mins
Secondary	Total surgical time	Total surgical time	1 hour
Secondary	Total Rocuronium doses during surgery	Total Rocuronium doses during surgery	1 hour
Secondary	Pain score at Postoperative room	describe by 11 points Numeric rating scales (0-10). From 0 which means "no pain" to 10 means "worst pain"	1 hour
Secondary	Heart Rate	Every beat per minutes heart rate during CO2 inflation	every 5 mins
Secondary	Respiratory complications	Record any respiratory complications including desaturations (<95%, more than 30 seconds, Rispiratory rate < 8), aspiration or airway obstruction	Every 5 mins