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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048045


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name