Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy

March 15, 2019 updated by: Yonsei University
The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on postoperative quality of recovery after laparoscopic cholecystectomy

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II patients aged between 20 and 65 year undergoing laparoscopic cholecystectomy due to gallbladder polyp or asymptomatic gallstones without cholecystitis

Exclusion Criteria:

  1. Steroid therapy or immunocompromised patients
  2. Diabetes mellitus
  3. Allergy to lidocaine or dexamethasone
  4. Severe renal dysfunction (serum creatinine more than 1.6mg/dl)
  5. Severe liver disease ( liver enzymes more than two times normal values)
  6. History of atrioventricular block
  7. Have a difficulty in understanding QoR-40 (40-item quality-of-recovery scoring system) or Korean language
  8. History of physicologic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone group
Drug: Dexamethasone
Dexamethasone 8mg in normal saline (total volume 25mL) was infused after tracheal intubation, and normal saline was continuously infused at the rate of 0.2 ml Kg-1 h-1 until the end of surgery (at the time of skin closure).
Experimental: Lidocaine group
Drug: Lidocaine
Lidocaine 2mg Kg-1 in normal saline (total volume 25mL) was infused after tracheal intubation, and lidocaine was infused at the rate of lidocaine 2mg Kg-1 h-1 (0.2 ml Kg-1 h-1, equivalent volume as normal saline in dexamethasone group) until the end of surgery (at the time of skin closure).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoR-40 score
Time Frame: from baseline to 3 hours on the day after surgery
40-item quality-of-recovery scoring system
from baseline to 3 hours on the day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of postoperative nausea and vomiting
Time Frame: from baseline to 3 hours on the day after surgery
10 cm-visual analogue scale
from baseline to 3 hours on the day after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic request
Time Frame: from baseline to 3 hours on the day after surgery
from baseline to 3 hours on the day after surgery
Number of rescue pain reliever
Time Frame: from baseline to 3 hours on the day after surgery
from baseline to 3 hours on the day after surgery
Severity of postoperative pain
Time Frame: from baseline to 3 hours on the day after surgery
10 cm-visual analogue scale
from baseline to 3 hours on the day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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