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

Gallbladder Polyp Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02224170
• Other study ID #: 4-2014-0530
• Status: Terminated
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Gallstones Without Cholecystitis
• Cholecystitis
• Gallbladder Polyp
• Gallstones

Intervention

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).
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Yonsei University College of Medicine, Seoul, Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to first analgesic request		from baseline to 3 hours on the day after surgery
Other	Number of rescue pain reliever		from baseline to 3 hours on the day after surgery
Other	Severity of postoperative pain	10 cm-visual analogue scale	from baseline to 3 hours on the day after surgery
Primary	QoR-40 score	40-item quality-of-recovery scoring system	from baseline to 3 hours on the day after surgery
Secondary	Incidence and severity of postoperative nausea and vomiting	10 cm-visual analogue scale	from baseline to 3 hours on the day after surgery