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

NCT02224170 | Terminated

• 1 other identifier: 4-2014-0530
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on postoperative quality of recovery after laparoscopic cholecystectomy

Conditions

Gallbladder Polyp; Asymptomatic Gallstones Without Cholecystitis

Keywords

Dexamethasone; Lidocaine; Quality of Recovery; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• QoR-40 score

  40-item quality-of-recovery scoring system

  from baseline to 3 hours on the day after surgery

Secondary Outcomes (1)

• Incidence and severity of postoperative nausea and vomiting

  from baseline to 3 hours on the day after surgery

Other Outcomes (3)

• Time to first analgesic request

  from baseline to 3 hours on the day after surgery

• Number of rescue pain reliever

  from baseline to 3 hours on the day after surgery

• Severity of postoperative pain

  from baseline to 3 hours on the day after surgery

Study Arms (2)

Lidocaine group

EXPERIMENTAL

Drug: Lidocaine

Dexamethasone group

ACTIVE COMPARATOR

Drug: Dexamethasone

Interventions

Lidocaine DRUG

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).

Lidocaine group

Dexamethasone DRUG

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).

Dexamethasone group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Lidocaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

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

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 25, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

KR (1)