| CTRI Number |
CTRI/2025/06/088584 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the Perfusion index using a pulse oximeter to predict if there will be hypotension after giving spinal anaesthesia in patient undergoing lower segment caesarean section (LSCS).
|
|
Scientific Title of Study
|
Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section |
| 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 Rajan Verma |
| Designation |
Professor, Department of anesthesia, Government medical college, amritsar |
| Affiliation |
Government medical college, amritsar |
| Address |
Department of Anaesthesia Government medical college Amritsar Punjab 143001 India
Department of Anaesthesia Government medical college Amritsar Punjab 143001 India
Amritsar
PUNJAB
143001
India |
| Phone |
9815267049 |
| Fax |
|
| Email |
rajan.verma0102@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan Verma |
| Designation |
Professor, Department of anesthesia, Government medical college, amritsar |
| Affiliation |
Government medical college, amritsar |
| Address |
Department of Anaesthesia Government medical college Amritsar Punjab 143001 India
Department of Anaesthesia Government medical college Amritsar Punjab 143001 India
Amritsar
PUNJAB
143001
India |
| Phone |
9815267049 |
| Fax |
|
| Email |
rajan.verma0102@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan Verma |
| Designation |
Professor, Department of anesthesia, Government medical college, amritsar |
| Affiliation |
Government medical college, amritsar |
| Address |
Department of Anaesthesia Government medical college Amritsar Punjab 143001 India
Department of Anaesthesia Government medical college Amritsar Punjab 143001 India
Amritsar
PUNJAB
143001
India |
| Phone |
9815267049 |
| Fax |
|
| Email |
rajan.verma0102@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Government medical college Amritsar Punjab |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesia |
Government medical college Amritsar Punjab |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vibhav Prashant Joshua |
Government medical college, Amritsar |
Department of Anaesthesia, Government medical college, Amritsar, PUNJAB
Amritsar
PUNJAB |
8054187064
drvibhavjoshua@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutuional Ethics Committee, Government medical college, Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients with baseline perfusion index of less than 3.5 were taken and their baseline perfusion index and hemodyamics will be recorded and then the patient will be given given spinal anesthesia along with coloading of ringer lactate. |
Patient will be prepared for elective caesarean section. Patients baseline perfusion index and baseline haemodynamic readings will be noted before giving spinal anesthesia. Co loading will be done while giving spinal anesthesia in left lateral position. Intraoperative Perfusion index and haemodynamic readings will be noted and comapred to preoperative readings. Total duration of intervention is from preoperative preperation to completion of surgery. |
| Comparator Agent |
Patients with baseline perfusion index of more than 3.5 were taken and their baseline perfusion index and hemodyamics will be recorded and then the patient will be given given spinal anesthesia along with coloading of ringer lactate. |
Patient will be prepared for elective caesarean section. Patients baseline perfusion index and baseline haemodynamic readings will be noted before giving spinal anesthesia. Co loading will be done while giving spinal anesthesia in left lateral position. Intraoperative Perfusion index and haemodynamic readings will be noted and comapred to preoperative readings. Total duration of intervention is from preoperative preperation to completion of surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients belonging to ASA grade I and II
Patients undrgoing elective lower segment caesarean section |
|
| ExclusionCriteria |
| Details |
Patients refusal
Patients age more than 35 years
Patients of ASA grade III and IV
Preterm and post term patients
Patients with placenta previa
Patients with Gestational diabetes mellitus
Patients with cardiovascular diseases
Patients with central nervous system diseases
Patients with coagulation disorder or on anticoagulation theray
Patients with conditions perdisposing to hypotension
Patients with contraindications to spinal anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To asses the correlation between perfusion index and incidence of hypotension following spinal anesthesia in patients undergoing elective caesarean section.
|
Time from preoperative period till the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asses the response of drugs phenyephrine and ephedrine on blood pressure.
To observe complications such as hypotension and bradycardia. |
Time from preoperative period till the end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
17/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a prospective randomized double blind study to compare perfusion index in predicting hypotension following spinal anaesthesia in lower segment caesarean section was conducted on one hundred twenty patients belonging to American Society of Anaesthesiologist (ASA) Grade I and II, of child bearing age i.e., 20 to 35 years, posted for LSCS under spinal anaesthesia, admitted in Guru Nanak Dev Hospital affiliated to Government Medical College, Amritsar. Patients will be divided into 2 groups of 60 each based on PI index. Group A : Patients with baseline perfusion index <3.5, Group B : Patients with baseline perfusion index >3.5. Patients from Group A and Group B will be divided into 2 groups based on the drug used to manage episodes of hypotension. Group E : Ephedrine and Group P : Phenylephrine. Blood pressure after drug administration and bolus dose requirements between two groups will be compared. |