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

NCT02762890 | Completed

• 1 other identifier: 4-2016-0206
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Surgical condition

  within 48 hours after the end of surgery

• shoulder pain

  within 48 hours after the end of surgery

• abdominal pain

  within 48 hours after the end of surgery

• nausea and vomiting

  within 48 hours after the end of surgery

Study Arms (2)

Deep neuromuscular blockade

EXPERIMENTAL

Rocuronium will be administered continuously to achieve post-tetanic count 1-2 during surgery.

Drug: Deep neuromuscular blockade

Moderate neuromuscular blockade

ACTIVE COMPARATOR

Rocuronium will be administered continuously to achieve Train-of-four 1-2 during surgery.

Drug: Moderate neuromuscular blockade

Interventions

Deep neuromuscular blockade DRUG

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.

Deep neuromuscular blockade

Moderate neuromuscular blockade DRUG

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.

Moderate neuromuscular blockade

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Neuromuscular disease
• History of malignant hyperthermia
• Significant renal or hepatic dysfunction
• Allergy to sugammadex or rocuronium

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University

Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 5, 2016
• Study Start: October 6, 2016
• Primary Completion: February 27, 2017
• Study Completion: February 27, 2017
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)