Asymptomatic Gallstones Without Cholecystitis, Gallbladder Polyp
Conditions
Keywords
Dexamethasone, Lidocaine, Quality of Recovery, Laparoscopic cholecystectomy
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
Interventions
DRUGLidocaine
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).
DRUGDexamethasone
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).
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR-40 score | from baseline to 3 hours on the day after surgery | 40-item quality-of-recovery scoring system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of postoperative nausea and vomiting | from baseline to 3 hours on the day after surgery | 10 cm-visual analogue scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 10 cm-visual analogue scale |
Countries
South Korea
Outcome results
None listed