| CTRI Number |
CTRI/2024/03/063656 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
To detect hypotension in pregnant women undergoing caesarean section after spinal anesthesia by pulse oximeter |
|
Scientific Title of Study
|
Perfusion index derived from a pulse oximeter can predict the incidence of hypotension during spinal anaesthesia for lower segmental caesarean section -A prospective observational 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 |
Meda venkata srinivas |
| Designation |
Assistant professor |
| Affiliation |
Government medical college, Cuddapah |
| Address |
Department of anesthesiology,
Government medical college,
Putlampalli,
Cuddapah,
Department of anesthesiology,
Government medical college,
Putlampalli,
Cuddapah.
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
09866301497 |
| Fax |
|
| Email |
srinivasmedadoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meda Venkata Srinivas |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College,Cuddapah |
| Address |
Department of anesthesia,
Government Medical College,
Putlampalli,
Cuddapah,
Department of anesthesia,
Government Medical College,
Cuddapah
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9866301497 |
| Fax |
|
| Email |
srinivasmedadoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meda Venkata Srinivas |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College,Cuddapah |
| Address |
Department of anesthesia,
Government Medical College,
Putlampalli,
Cuddapah,
Department of anesthesia,
Government Medical College,
Cuddapah
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9866301497 |
| Fax |
|
| Email |
srinivasmedadoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology,
Government Medical College,
Kadapa |
|
|
Primary Sponsor
|
| Name |
Dr Sunil Chiruvella |
| Address |
Department of anesthesiology,
Govenment Medical College,Cuddapah |
| 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 |
| Meda Venkata Srinivas |
Government General Hospital,Cuddapah |
room no 200,IP block
Department of Anesthesiology,
Government General Hospital
Putlampalli, Cuddapah-516002
Cuddapah
ANDHRA PRADESH |
9866301497
srinivasmedadoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College,Kadapa, |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
100 full term (37 week completed) ,singleton pregnant women of age between 18 to 45 years, undergoing elective lower segment caesarean section (LSCS) under subarachnoid block will be included in this study. |
|
| ExclusionCriteria |
| Details |
patients who refused, patients posted for emergency LSCS, patients with associated cardiovascular, respiratory and renal diseases. patients who received preloading of intravenous fluid. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to establish a correlation preoperative perfusion index and intraoperative hypotension following spinal anesthesia in lower segmental caesarian section |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| requirement of vasopressor concerning perfusion index |
Baseline |
|
|
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)
|
14/03/2024 |
| 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="0"
Months="3"
Days="5" |
|
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 study is a prospective observational study.Hypotension during spinal anaesthesia for caesarean delivery is a result of decreased vascular resistance due to sympathetic blockade and decreased cardiac output due to blood pooling in blocked areas of the body. Change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. Hypotension in the mother leads to maternal as well as fetal complications. Thus ,the prediction of possible hypotension will aid in preventing the associated complications. Low blood pressure resulting from reduced systemic vascular resistance leads to a higher perfusion index owing to enhancement in the pulsatile component caused by vasodilatation. The perfusion index derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone . Higher perfusion index was associated with increased risk of hypotension. |