| CTRI Number |
CTRI/2024/09/073453 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study using perfusion index as an evaluator of hypotension following thiopentone induction in General anaesthesia |
|
Scientific Title of Study
|
An observational study using perfusion index as predictor of hypotension following thiopentone induction in General anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SASEETHA S K |
| Designation |
Postgraduate Department of Anaesthesiology and critical care. |
| Affiliation |
Sri Venkateshwaraa medical college hospital and research center |
| Address |
Department of Anaesthesiology and critical care.Sri Venkateshwaraa medical college hospital and research centerNo 13-A,pondy-villupuram main road,Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8903610776 |
| Fax |
|
| Email |
dreamydoctor24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Jayashri Devi |
| Designation |
Professor |
| Affiliation |
Sri Venkateshwaraa medical college hospital |
| Address |
Department of Anaesthesia and critical care,Sri Venkateshwaraa medical college hospital and research center,No 13-A,pondy-villupuram main road,Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8754689690 |
| Fax |
|
| Email |
dr.jayashridevi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Jayashri Devi |
| Designation |
Professor |
| Affiliation |
Sri Venkateshwaraa medical college hospital |
| Address |
Department of Anaesthesia and critical care,Sri Venkateshwaraa medical college hospital.No 13-A,pondy-villupuram main road,Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8754689690 |
| Fax |
|
| Email |
dr.jayashridevi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa medical college hospital and research center,No.13-A,pondy-Villupuram main road,Ariyur,Puducherry,India-605102 |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwaraa medical college hospital and research center |
| Address |
NO.13-A,Pondy-villupuram mainroad,Ariyur,puducherry 605102 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saseetha S K |
Sri Venkateshwaraa medical college hospital and research center |
Department of Anaesthesia,OT complex,room no.1;No13-A;Pondy--Villupuram main rod,Ariyur
Pondicherry
PONDICHERRY |
8903610776
dreamydoctor24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R031||Nonspecific low blood-pressure reading, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patient of either sex with age limit of 18 to 60 years
2.ASA class1 and ASA class2
3.Patients who are electively posted for surgery under general anaesthesia using thiopentone as an inducing agent |
|
| ExclusionCriteria |
| Details |
1.Patients with uncontrolled diabetes mellitus and hypertension
2.Pregnant females
3.Patients with neurological or psychiatric illness, chronic pain disorder,peripheral vascular disease,ischemic heart disease
4.Patient with autonomic dysfunction or on drugs which affect autonomic dysfunction
5.Allergy to any drug used in the study
6.Hemodynamically unstable patients
7.Patients who refused to give consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the baseline perfusion index(PI) and its variability in predicting hypotension following induction with intravenous propofol during general anaesthesia |
pre-induction;1 min 2 min 3 min 5 min post induction;1 min 2 min 5 min 10min 15 min post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for association of perfusion index with haemodynamic parameters such as heart rate(HR),oxygen saturation(spo2),systolic blood pressure(SBP),diastolic blood pressure(DBP) and mean arterial blood pressure(DBP) |
pre-induction;1min 2min 3min 5 min post induction;1min 2 min 5 min 10 min 15 min post intubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
This study will be undertaken after obtaining the Institutional Ethical Committee clearance.Subject will be recruited based on inclusion and exclusion criteria.Participants will be first explained what procedure is to be done in detail with its advantages and disadvantages during pre-anesthetic assessment. Informed consent will be obtained from all the patients following which demographic details including age and sex, along with detailed medical history and other comorbid conditions will be noted.All inpatients belonging to ASA I and ASA II undergoing elective surgery under general anaesthesia in SVMCH&RC who fulfill the inclusion criteria will be enrolled in the study afterIEC approval.On the day of surgery,all monitors will be attached, an electrocardiogram,non invasive blood pressure(NIBP) and pulse oximetry(B125M patient monitor)will be placed on the index finger contralateral to the side of the blood pressure cuff.Pre induction values of perfusion index(PI),Heart rate(HR),systolic blood pressure(SBP) diastolic blood pressure(DBP) and mean arterial blood pressure(MAP) will be noted.Routine general anaesthesia steps will be followed as per institutional protocol.Perfusion index(PI),Heart rate(HR),systolic blood pressure(SBP) diastolic blood pressure(DBP) and mean arterial blood pressure(MAP)will be recorded at a timeline 1 minute,2minute,3 minute,5 minute following thiopentone induction and 1 minute, 2minute,5 minute,10 minute and 15 minute post intubation.All study parameters will be assesed by the primary investigator. |