| CTRI Number |
CTRI/2025/12/098397 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find ways to predict low blood pressure after spinal anesthesia in women undergoing elective caesarean delivery |
|
Scientific Title of Study
|
A Comparative study to predict hypotension following spinal anesthesia in elective cesarean section using perfusion indexed derived from pulse oximetry and baseline hemodynamic parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raghuram Madireddy |
| Designation |
post graduate trainee |
| Affiliation |
Netaji Subhash Medical College and Hospital |
| Address |
Department of Anesthesia, Netaji Subhash Medical College, Amhara, Bihta, Patna, Bihar, India
Patna
BIHAR
801106
India |
| Phone |
9560116126 |
| Fax |
|
| Email |
raghurammaddireddy@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Faseehullah Alam |
| Designation |
Assistant Professor |
| Affiliation |
Netaji Subhash Medical College and Hospital |
| Address |
Department of Anesthesia, Netaji Subhash Medical College, Amhara, Bihta, Patna, Bihar, India
Patna
BIHAR
801106
India |
| Phone |
9155366231 |
| Fax |
|
| Email |
faseehullah.alam@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghuram Madireddy |
| Designation |
post graduate trainee |
| Affiliation |
Netaji Subhash Medical College and Hospital |
| Address |
Department of Anesthesia, Netaji Subhash Medical College, Amhara, Bihta, Patna, Bihar, India
BIHAR
801106
India |
| Phone |
9560116126 |
| Fax |
|
| Email |
raghurammaddireddy@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Raghuram Madireddy |
| Address |
Department of Anesthesia, Netaji Subhash Medical College and Hospital, Amhara, Bihta, Patna, Bihar, India
PIN 801106 |
| Type of Sponsor |
Other [Self] |
|
|
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 Raghuram Madireddy |
Netaji Subhash Medical College and Hospital |
Department of Anesthesia, Netaji Subhash Medical College and Hospital, Amhara, Bihta
Patna
BIHAR |
9560116126
raghurammaddireddy@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CREC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant patients who are undergoing elective cesarean section of American Society of Anesthesiologist 1 & 2, with singleton live fetus more that 37 weeks of gestation |
|
| ExclusionCriteria |
| Details |
American Society of Anesthesiologist 3 to 6, emergency cesarean section, preterm cesarean section, allergy to local anesthetic drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the predictive value of the perfusion index and baseline hemodynamic parameters for hypotension after spinal anesthesia |
Baseline and then every 5 minutes for first 2 hours and then every 15 minutes for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical utility of perfusion index in guiding prophylactic interventions |
24 hours |
|
|
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)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
Spinal anesthesia is the preferred technique for cesarean section due to its simplicity, rapid onset and effectiveness. Traditionally, baseline systolic and diastolic blood pressures, heart rate have been used to predict the risk of hypotension. Incorporating perfusion index alongside traditional hemodynamic parameters may provide a more comprehensive and individualized approach to identify patients at risk. The present study aims to evaluate and compare the predictive value of perfusion index and conventional hemodynamic variables in forecasting hypotension following spinal anesthesia in patients undergoing elective cesarean section. |