UMIN-CTR Clinical Trial

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
Email	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
Email	swethasantosh9@gmail.com

Sponsor
Institute	Manipal Hospitlals, Old airport road ,Bangalore
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048045