The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy

NCT02036827 | Completed Phase 4

• 1 other identifier: 3-2013-0210
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.

Conditions

Pain, Postoperative

Keywords

Pain, Postoperative; Neuromuscular Blocking Agents; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Shoulder tip pain

  The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.

  upto postoperative 24 hours

Secondary Outcomes (6)

• Postoperative pain

  upto postoperative 24 hours

• Postoperative nausea and vomiting

  upto postoperative 24hours

• Intraoperative hemodynamics

  upto postoperative 24hours

• pulmonary compliance

  upto postoperative 24 hours

• Satisfaction of the surgeon

  upto postoperative 24 hours

Study Arms (3)

moderate NMB + standard pressure

ACTIVE COMPARATOR

Investigators will administrate rocuronium until moderate neuromuscular blockade (Train of Four \>=1, Post-tetanic count\>=8) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg.

Drug: Rocuronium

deep NMB + standard pressure

ACTIVE COMPARATOR

Investigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count\<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg.

Drug: Rocuronium

deep NMB + low pressure

ACTIVE COMPARATOR

Investigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count\<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 8 mmHg.

Drug: Rocuronium

Interventions

Rocuronium DRUG

We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.

Also known as: Neurpmuscular blockade is provides vy Rocuronium Bromide

deep NMB + low pressure; deep NMB + standard pressure; moderate NMB + standard pressure

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• physical status by American society of Anesthesiology; 1 or 2 patients
• patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy

You may not qualify if:

• patient with myasthenia gravis
• allergy to rocuronium or sugammadex
• patient with shoulder pain disease (Ex. rotator cuff tear)
• psychological disease
• patients who cannot understand Korean

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Gangnam severance hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yon Hee Shim, MD, PhD

  Yonsei University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: January 15, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

KR (1)