CTRI Number |
CTRI/2022/06/043517 [Registered on: 27/06/2022] Trial Registered Prospectively |
Last Modified On: |
03/08/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
To compare the occurrence of fall in blood pressure after spinal anaesthesia among normal pregnant women and pre-eclamptic women who are undergoing cesarean section |
Scientific Title of Study
|
Comparison of incidence of spinal anaesthesia induced hypotension between patients with severe preeclampsia and low risk pregnant women undergoing emergency caesarean delivery: a prospective cohort study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Aswini Kuberan |
Designation |
Assistant Professor |
Affiliation |
JIPMER |
Address |
Dept. of Anaesthesia
JIPMER JIPMER
Gorimedu,
Dhanvanthari Nagar
Puducherry Pondicherry PONDICHERRY 605006 India |
Phone |
9914017949 |
Fax |
|
Email |
ashdoctor.kuberan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Varun Nair |
Designation |
Junior Resident |
Affiliation |
JIPMER |
Address |
Dept.of Anaesthesia
JIPMER
Pondicherry PONDICHERRY 605006 India |
Phone |
6282124558 |
Fax |
|
Email |
varunloyolite@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Varun Nair |
Designation |
Junior Resident |
Affiliation |
JIPMER |
Address |
Dept.of Anaesthesia
JIPMER
Pondicherry PONDICHERRY 605006 India |
Phone |
6282124558 |
Fax |
|
Email |
varunloyolite@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
JIPMER |
Address |
Dean research,
JIPMER
Dhanvanthari Nagar
Gorimedu
Puducherry
D |
Type of Sponsor |
Research institution and hospital |
|
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 |
Varun B Nair |
JIPMER |
Dept. of anaesthesia Pondicherry PONDICHERRY |
6282124558
varunloyolite@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee For Observational Studies DHR REG. N0. EC/NEW/INST/2020/331 |
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
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Female |
Details |
(Group 1)
Women with severe preeclampsia undergoing emergency caesarean section under spinal anaesthesia.
(Group 2)
Low risk pregnant women undergoing emergency caesarean section under spinal anaesthesia
|
|
ExclusionCriteria |
Details |
1.NICE 1 planned for General anaesthesia
2.Patients who received labour analgesia planned for LSCS
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Incidence of post spinal hypotension in both the groups. ( 20 % reduction in the baseline MAP) w678 |
Every minute until 20 minutes after spinal anaesthesia administration |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Comparison of total dose of vasopressors used in managing post spinal hypotension between two groups.
2) Comparison of serum magnesium, serum uric acid, serum endothelin 1(ET I) and urine norepinephrine (NE) to incidence of hypotension in severe pre-eclampsia.
3) Comparison of neonatal outcomes (Apgar score, cord blood pH estimation, base deficit and serum bicarbonates) between the groups
|
1) Intaoperatively when hypotension is noted
2) Pre-operative blood sample
3) End -opertive/immediately after child birth |
|
Target Sample Size
|
Total Sample Size="142" Sample Size from India="142"
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)
|
30/06/2022 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Problem statement: Historical belief regarding optimal anaesthetic technique for caesarean delivery in severe preeclamptic women was that spinal anaesthesia causes precipitous hypotension in severe pre-eclampsia patients due to rapid sympathetic blockade, contracted intravascular volume and limited fluid administration.. Later many clinical studies confirmed the safety of spinal anaesthesia in severe pre-eclampsia patients and recommended lumbar neuraxial anaesthesia as the preferred mode of anaesthesia. The same authors observed the incidence of hypotension was less in severe pre eclamptic patients compared to that of normal pregnant women.. These authors speculated that higher sympathetic activity with high vascular tone, raised circulating factors with potent pressor activity and increased sensitivity to pressor drugs contributed to lesser degree of hypotension. However, a multicentre study reported a higher incidence of hypotension is spinal anaesthesia compared to epidural anaesthesia3. Also fluid strategies used in the above studies are not consistent with the current practice of co-loading. Rationale: Although risk comparison trials in severe pre-eclampsia has reported less incidence of spinal anaesthesia induced hypotension , data supporting the same among the Indian population is lacking. Moreover, varied incidences of hypotension in severe pre-eclamptic patients have been reported (the incidence of hypotension documented in the study by Visalyaputra et al was 51% as opposed to 16.6% in the study conducted by Antoine G. M. Aya et al.) Also fluid management protocols used are not consistent with present practice. The studies have followed preloading of IV fluids preoperatively {1500-2000 ml of ringer lactate 500ml of 6% hydroxyethyl starch} as opposed to the current concept favouring co-loading of fluids. Due to these conflicting observations, we would like to observe and compare the incidence of post spinal hypotension between severe pre-eclamptic patients and low risk pregnant women undergoing emergency caesarean delivery. Novelty: Varied incidence of hypotension in severe pre-eclampsia after spinal anaesthesia has been reported. The fluid management protocol used in the studies was also not consistent with the current practice. Furthermore, major studies had a population consisting of elective caesarean section and no study provided data neither on emergency caesarean sections exclusively nor on an Indian population. Expected outcome and application: The expected outcome would be, whether the observation of low incidence of post-spinal hypotension made by previous studies is prevalent in our population of severe pre-eclamptic women undergoing emergency LSCS. |