Back to resultsComparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy
Primary Purpose
Gallbladder Polyp, Asymptomatic Gallstones Without Cholecystitis
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lidocaine
Dexamethasone
Sponsored by
About this trial
This is an interventional prevention trial for Gallbladder Polyp focused on measuring Dexamethasone, Lidocaine, Quality of Recovery, Laparoscopic cholecystectomy
Eligibility Criteria
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:
- 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
Sites / Locations
- Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lidocaine group
Dexamethasone group
Arm Description
Outcomes
Primary Outcome Measures
QoR-40 score
40-item quality-of-recovery scoring system
Secondary Outcome Measures
Incidence and severity of postoperative nausea and vomiting
10 cm-visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02224170
Brief Title
Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to difficulties in recruiting the subjects.
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Polyp, Asymptomatic Gallstones Without Cholecystitis
Keywords
Dexamethasone, Lidocaine, Quality of Recovery, Laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine group
Arm Type
Experimental
Arm Title
Dexamethasone group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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).
Primary Outcome Measure Information:
Title
QoR-40 score
Description
40-item quality-of-recovery scoring system
Time Frame
from baseline to 3 hours on the day after surgery
Secondary Outcome Measure Information:
Title
Incidence and severity of postoperative nausea and vomiting
Description
10 cm-visual analogue scale
Time Frame
from baseline to 3 hours on the day after surgery
Other Pre-specified Outcome Measures:
Title
Time to first analgesic request
Time Frame
from baseline to 3 hours on the day after surgery
Title
Number of rescue pain reliever
Time Frame
from baseline to 3 hours on the day after surgery
Title
Severity of postoperative pain
Description
10 cm-visual analogue scale
Time Frame
from baseline to 3 hours on the day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Facility Information:
Facility Name
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy
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