| CTRI Number |
CTRI/2022/08/044765 [Registered on: 22/08/2022] Trial Registered Prospectively |
| Last Modified On: |
12/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comaprison of fall in blood pressure between 2 minute sitting position and immediately lying down after spinal anaesthesia in elective caesarean section |
|
Scientific Title of Study
|
A randomised interventional study to compare the incidence of hypotension between 2-minute sitting position and immediately lying down position after spinal anaesthesia with hyperbaric bupivacaine in elective caesarean section at SMS Medical College Jaipur in 2021-2023 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HARPREET KAUR |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
dillykaur1977@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HARPREET KAUR |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
dillykaur1977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR EKTA RANI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Adarsh nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
08813059821 |
| Fax |
|
| Email |
ekta.rani05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Sawai Man Singh Medical College and Attached Hospitals Jaipur |
| Address |
JLN Marg Adarsh Nagar Jaipur |
| Type of Sponsor |
Government 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 EKTA RANI |
Sawai Man Singh Medical College and Attached Hospitals |
Department of Anaesthesiology,2nd floor, Dhanwantari Building , SMS Medical College and Attached hospitals, JLN Mard, Adarash nagar, Jaipur
Jaipur
RAJASTHAN |
8813059821
ekta.rani05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sawai Man Singh Medical College and Attached Hospitals |
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 |
| Intervention |
2 minute sitting position |
Patient will be kept for 2 minute sitting position after giving spinal anaesthesia. |
| Comparator Agent |
Immediately lying down |
Pateint will be immediately placed in lying position after giving spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1- Patient undergoing elective caesarean section under spinal anaesthesia
2- Patient age group 18-30 years
3- Patients who give written informed consent in vernacular language. |
|
| ExclusionCriteria |
| Details |
1- ASA grade 3 and 4.
2- Patients with preclampsia , chronic hypertension and diabetes.
3- Patients with allergy to drugs used in the study.
4- Patients with contraindication with neuraxial anaesthesia.
5- Patients with blood pressure below 90 mmHg and heart rate below 50/min.
6- Patients with a history of drug abuse or addictions and any unexpected accidents.
7- Patients undergoing emergency caesarean section. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arteriolar pressure (MAP). |
Intraoperative 1 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Comparison of other hemodynamic parameters like heart rate (HR),,oxygen saturation(Spo2) and respiratory rate(RR).
2-Comparison of time to achieve sensory block(T6 dermatome) and motor block(modified bromage score3) betwwen two groups.
3-Comparison of vasopressor requirements.
4-Evaluation of secondary outcomes(i.e. nausea,vomiting,shivering,pruritus) between the groups. |
Intraoperative 1 hour |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/08/2022 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will help us to understand the patient’s different positions on the incidence of hypotension after spinal anesthesia in lower segment cesarean section. |