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

Not Applicable

Terminated

• Conditions: Gallbladder Polyp; Asymptomatic Gallstones Without Cholecystitis
• Interventions: Drug: Lidocaine; Drug: Dexamethasone

• Registration Number: NCT02224170
• Lead Sponsor: Yonsei University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-25
• Study Start: 2014-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Lidocaine	-
Dexamethasone group	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
QoR-40 score	from baseline to 3 hours on the day after surgery	40-item quality-of-recovery scoring system

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of postoperative nausea and vomiting	from baseline to 3 hours on the day after surgery	10 cm-visual analogue scale

Trial Locations

Locations (1)

Department of Surgery, Yonsei University College of Medicine, Seoul, Korea; 🇰🇷 Seoul, Korea, Republic of