| CTRI Number |
CTRI/2024/02/062962 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Analytical Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess hemodynamic changes between preeclamptic versus healthy parturients undergoing elective cesarean section under spinal anaesthesia |
|
Scientific Title of Study
|
An observational comparative study to assess the hemodynamic changes between preeclampsia patient versus healthy parturients after spinal anaesthesia during elective cesarean 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 Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital |
| Address |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Kaur |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital |
| Address |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
9899785993 |
| Fax |
|
| Email |
rupihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kshirabdhi Tanaya Mohapatra |
| Designation |
Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospital |
| Address |
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
8527467352 |
| Fax |
|
| Email |
crimson.jinx1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur |
| Address |
Department of anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 |
| 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 Harpreet Kaur |
Sawai Man Singh Medical College and attached hospital |
Obstretics and Gynecology Operation theatre , Department of Anaesthesiology
Jaipur
RAJASTHAN |
9899785993
rupihar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient providing consent
Patient belonging to ASA II and III
Patient with preeclampsia BP more than 140/90 mmHg after 20 weeks of gestation and proteinuria more than plus 2
|
|
| ExclusionCriteria |
| Details |
Non cooperative patient
Patient should not be part of any other study
Patient with contraindication to neuraxial anaesthesia
patient with cardiac diisease , chronic hypertension and gestational hypertension
Patient with renal disease , coagulopathy platelet count less than 80000 and high spinal
Patient with active labor , eclampsia , abruption placenta , placenta previa and twin pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in intraoperative hemodynamic variables in terms of mean SBP , mean DBP , mean MAP (mmHg ) and mean HR (min)
2. Difference in mean total dose of ephedrine required (mg)
3. Difference in mean total amount of intraoperative fluid required (ml) |
1. 00 min
2. 2min
3. 4min
4. 6min
6. 8min
7. 10min
8. 12min
9. 14min
10. 20min
11. 25min
12. 30min
13. 35min
14. 40min
15. 45min
16. 50min
17. 55min
18. 60min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
25/02/2024 |
| 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="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 anaesthesia is generally preferred anaesthetic technique in preeclampsia patients as there are lower incidence of spinal induced hypotension and the vasopressor requirement in them . A total of 100 parturients fulfilling the inclusion criteria ( 50 preeclamptic and 50 healthy ) will be enrolled in the study after providing informed written consent . In operation theatre baseline hemodynamic variable ( systolic blood pressure ,diastolic blood pressure , mean arterial pressure , HR and SPO2 ) will be recorded . A 18G cannula will be secured and preoperative fluid equal to 10ml /kg of Ringer’s lactate will be administered to each patient over the course of 15- 20 min. Under aseptic precaution Spinal anaesthesia will be performed with 10mg hyperbaric 0.5% bupivacaine in two groups in sitting position in the L3 - L4 vertebral interspace , Each patient will be placed in supine position with a left lateral tilt of 15- 20 degree . The height of sensory block will be assessed using a pin prick test. After achieving an adequate sensory block (T6 level ) the surgery will be started . HR and BP will be recorded before performing spinal anaesthesia , at 2 min interval for 15 min after the block and then every 5 min until the end of surgery . Patient will also be assessed for hemodynamic changes , requirement of injection ephedrine , intraoperative fluid and complication if any . |