Comparison of Deep Neuromuscular Block and Moderate Neuromuscular Block on Quality of Recovery in Patients Undergoing Robotic Gastrectomy

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762890
• Other study ID #: 4-2016-0206
• Status: Completed
• Phase: N/A
• First received: May 4, 2016
• Last updated: December 15, 2017
• Start date: October 6, 2016
• Est. completion date: February 27, 2017

Study information

• Verified date: December 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate and compare the postoperative quality of recovery between the deep neuromuscular blockade and moderate neuromuscular blockade during robotic gastrectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 27, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patients aged 19-80 years who are scheduled for robotic gastrectomy

Exclusion Criteria:

• Neuromuscular disease

• History of malignant hyperthermia

• Significant renal or hepatic dysfunction

• Allergy to sugammadex or rocuronium

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Drug:
• Deep neuromuscular blockade
neuromuscular blockade will be performed using a continuous infusion of rocuronium. Post-tetanic count 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 4 mg/kg will be administered to reverse neuromuscular blockade.
• Moderate neuromuscular blockade
neuromuscular blockade will be performed using a continuous infusion of rocuronium. Train-of-four 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative quality of recovery	The postoperative quality of recovery will be evaluated at 24 and 48 hours after the end of surgery by the investigator who are blinded to the group assignments.	within 48 hours after the end of surgery.
Secondary	Surgical condition	Surgical condition will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.	within 48 hours after the end of surgery
Secondary	shoulder pain	shoulder pain will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.	within 48 hours after the end of surgery
Secondary	abdominal pain	abdominal pain will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.	within 48 hours after the end of surgery
Secondary	nausea and vomiting	nausea and vomiting will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.	within 48 hours after the end of surgery