CTRI

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CTRI Number

CTRI/2024/01/061050 [Registered on: 02/01/2024] Trial Registered Prospectively

Last Modified On:

27/12/2023

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Evaluation of perfusion index to assess analgesia in patients undergoing laparoscopic surgeries under general anaesthesia.

Scientific Title of Study

Assessment of perfusion index as an objective tool to assess analgesia during laparoscopic surgeries under general anaesthesia- A one year hospital based cross sectional study.

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Manish Manohar Shetty
Designation	POST GRADUATE
Affiliation	JAWAHARLAL NEHRU MEDICAL COLLEGE,KLES DR PRABHAKAR KORE HOSPITAL & MRC,BELAGAVI
Address	DEPARTMENT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE,NEHRU NAGAR,BELAGAVI 590010 Bangalore KARNATAKA 590010 India
Phone	8050488018
Fax
Email	manraksh181@gmail.com

Details of Contact Person
Scientific Query

Name	Dr CHAITANYA KAMAT
Designation	PROFESSOR
Affiliation	JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI
Address	DEPT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE,BELAGAVI 590010 Belgaum KARNATAKA 590010 India
Phone	8150038305
Fax
Email	drchaitanya12@gmail.com

Details of Contact Person
Public Query

Name	Dr CHAITANYA KAMAT
Designation	PROFESSOR
Affiliation	JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI
Address	DEPT OF ANAESTHESIOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE,BELAGAVI 590010 Belgaum KARNATAKA 590010 India
Phone	8150038305
Fax
Email	drchaitanya12@gmail.com

Source of Monetary or Material Support

KLES Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical college and hospital, Belagavi.

Primary Sponsor

Name	DR MANISH MANOHAR SHETTY
Address	Department of Anaesthesiology Jawaharlal Nehru Medical College, KLE, Belagavi- 590010
Type of Sponsor	Other []

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR MANISH MANOHAR SHETTY	KLES Dr Prabhakar Kore Hospital and MRC, Belagavi, Karnataka	Department of Anaesthesiology, General surgery OT Belgaum KARNATAKA	8050488018 manraksh181@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Jawaharlal Nehru Medical College, Institutional Ethics Committee, Jawaharlal Nehru Medical College, Belagavi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	ASSESSMENT OF PERFUSION INDEX AFTER ADMINISTRATION OF FENTANYL INTRAOPERATIVELY	PERFUSION INDEX AND OTHER HEMODYNAMIC PARAMETERS ARE NOTED AT VARIOUS TIME POINTS(BEFORE/AFTER INDUCTION AND PNEUMOPERITONEUM -p0).LATER,THE VALUES ARE RECORDED AT THE TIME OF INSERTION OF FIRST LAPAROSCOPIC PORT(p1) FOLLOWING WHICH A 0.5 MCG/KG INJECTION OF IV FENTANYL IS ADMINISTERED AND THE VALUES ARE RECORDED AT VARIOUS TIME POINTS AFTER THAT UNTIL 30 MINUTES OF SURGERY.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	Patients belonging to ASA grade I Patients of either sex aged 18-40 years undergoing elective laparoscopic surgeries under general anesthesia.

ExclusionCriteria

Details

1. Patient refusal
2. Neurological or psychiatric illness
3. Chronic pain disorder
4. Peripheral vascular disease
5. Hypertension, Diabetes mellitus, Ischaemic heart disease
6. Autonomic dysfunction or on drugs which affect autonomic dysfunction, allergy to any drug used in the study.
7. Unstable haemodynamic status.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To assess perfusion index as an objective tool to assess analgesia during laparoscopic surgeries under general anaesthesia.	Pre induction After induction After intubation P0(PNEUMOPERITONEUM) P1(FENTANYL GIVEN) P2(2ND PORT) P3(3RD PORT) 1 min 2 min 3 min 4 min 5 min 6 min 7 min 8 min 9 min 10 min 20 min 30 min

Secondary Outcome

Outcome	TimePoints
To correlate perfusion index with haemodynamic parameters such as heart rate, non invasive blood pressure & mean arterial pressure (MAP).	Pre induction After induction After intubation P0(PNEUNOPERITONEUM) P1(FENTANYL GIVEN) P2(2ND PORT) P3(3RD PORT) 1 MIN 2 MIN 3 MIN 4 MIN 5 MIN 6 MIN 7 MIN 8 MIN 9 MIN 10 MIN 20 MIN 30 MIN

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

10/01/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

10/01/2024

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Perfusion Index is a non invasive and a continuous measure of peripheral perfusion. The changes in sympathetic tone affect smooth muscle tone and can alter the perfusion reflected on perfusion index. This study investigates the changes in perfusion index due to painful stimuli in laparoscopic surgeries performed under general anaesthesia .