UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042101 |
|---|---|
| Receipt number | R000048045 |
| Scientific Title | A randomized controlled study to evaluate the effect of intraoperative lignocaine infusion on propofol consumption during laparoscopic cholecystectomy |
| Date of disclosure of the study information | 2020/10/31 |
| Last modified on | 2020/10/13 16:44:48 |
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Basic information
Public title
Lignocaine infusion to reduce propofol consumption in laparoscopic cholecystectomy
Acronym
Lignocaine infusion to reduce propofol consumption in laparoscopic cholecystectomy
Scientific Title
A randomized controlled study to evaluate the effect of intraoperative lignocaine infusion on propofol consumption during laparoscopic cholecystectomy
Scientific Title:Acronym
LIRPOL
Region
| Asia(except Japan) |
Condition
Condition
Perioperative period
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether intravenous lignocaine reduces propofol consumption during laparoscopic cholecystectomy using TCI (Target Controlled Infusion)
Basic objectives2
Others
Basic objectives -Others
Hemodynamic parameters
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess whether intravenous lignocaine reduces propofol consumption during laparoscopic cholecystectomy using TCI (Target Controlled Infusion)
Key secondary outcomes
Effect of lignocaine infusion on hemodynamic parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lignocaine drug infusion in perioperative period
Interventions/Control_2
Placebo(Normal saline) infusion in perioperative period
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Consenting adults undergoing laparoscopic cholecystectomy
ASA-1 and 2
Key exclusion criteria
1. Age < 18 years and > 65 years.
2. Patients not willing to participate in this study.
3. Emergency surgeries.
4. Morbid obesity or BMI>35
5. History of allergy to local anaesthetic agents.
6. History of chronic smoking.
7. Use of opioids or anti-arrhythmic drugs within 1 week of surgery.
8. Cardiorespiratory abnormalities NYHA class 3 and 4, severe COPD.
9. Liver dysfunction (bilirubin and liver enzymes values elevated by 50% of normal
10.Renal insufficiency (serum creatinine >1.6mg/dl)
11.Epilepsy or other neurological diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Swetha |
| Middle name | Malenahalli |
| Last name | Chandrashekarappa |
Organization
Manipal Hospitals
Division name
Anaesthesiology
Zip code
560017
Address
Manipal Hospitals, Old airport road, Bengalore
TEL
959481909899
swethasantosh9@gmail.com
Public contact
Name of contact person
| 1st name | Swetha |
| Middle name | Malenahalli |
| Last name | Chandrashekarappa |
Organization
Manipal Hospitals
Division name
Anaesthesiology
Zip code
560017
Address
Manipal Hospitlals, Old airport road ,Bangalore
TEL
959481909899
Homepage URL
swethasantosh9@gmail.com
Sponsor or person
Institute
Manipal Hospitlals, Old airport road ,Bangalore
Institute
Department
Personal name
Funding Source
Organization
Manipal Hospitlals, Old airport road ,Bangalore
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
manipal Hospitals
Address
Manipal Hospitlals, Old airport road ,Bangalore
Tel
959481909899
swethasantosh9@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Manipal Hospitals, bangalore
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 13 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048045
