| CTRI Number |
CTRI/2025/11/096998 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Height and weight adjusted dose versus fixed dose of hyperbaric bupivacaine for spinal anaesthesia in cesarean section to prevent maternal hypotension |
|
Scientific Title of Study
|
Height weight adjusted dose versus fixed dose of hyperbaric bupivacaine in elective cesarean section to prevent maternal hypotension A prospective, double blinded, Randomized Controlled 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 |
Dr Dhanya S |
| Designation |
Post Graduate |
| Affiliation |
RajaRajeswari Medical College and Hospital |
| Address |
Department Of Anaesthesiology,
RajaRajeswari Medical College and Hospital
202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9483701540 |
| Fax |
|
| Email |
dhanyasridhar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Petkar |
| Designation |
Professor |
| Affiliation |
RajaRajeswari Medical College and Hospital |
| Address |
Department Of Anaesthesiology,
RajaRajeswari Medical College and Hospital
202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
7726899533 |
| Fax |
|
| Email |
jokiran2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Petkar |
| Designation |
Professor |
| Affiliation |
RajaRajeswari Medical College and Hospital |
| Address |
Department Of Anaesthesiology,
RajaRajeswari Medical College and Hospital
202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
7726899533 |
| Fax |
|
| Email |
jokiran2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| RajaRajeswari Medical College And Hospital,
202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074 |
|
|
Primary Sponsor
|
| Name |
Dhanya S |
| Address |
RajaRajeswari Medical College And Hospital, 202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074 |
| 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 Dhanya S |
RajaRajeswari Medical College and Hospital |
RajaRajeswari Medical College And Hospital, 202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074
Bangalore
KARNATAKA |
9483701540
dhanyasridhar01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RajaRajeswari Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP FD |
In this, patients will receive fixed dose of 2ml 0.5% hyperbaric Bupivacaine
Route of administration - Intrathecally
Duration of Intervention - Subarachnoid block given before the onset of surgery
Frequency - at the time of induction
Dose - 2ml 0.5% hyperbaric Bupivacaine. |
| Intervention |
Group HW |
In this, patients will receive 0.5% hyperbaric Bupivacaine intrathecally, with the dosage according to their height and weight using Harten’s dosing chart
Dose - According to Height and weight adjusted dose using Hartens Chart
Reference - 1. Harten JM, Boyne I, Hannah P, Varveris D, Brown A. Effects of a height and weight adjusted dose of local anaesthetic for spinal anaesthesia for elective Caesarean section. Anaesthesia. 2005 Apr;60(4):348-53. doi: 10.1111/j.1365-2044.2005.04113.x. PMID: 15766337.
Frequency - at the time of Induction
Duration of intervention - Subarachnoid block given before the onset of surgery
Route of administration - Intrathecally
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant woman classified as ASA 2
Pregnant woman carrying singleton pregnancy (more than 37weeks of gestation)
Pregnant woman with weight 50-110kg and height of 140-180cm
Patients who is scheduled for elective cesarean section |
|
| ExclusionCriteria |
| Details |
Pregnant belonged to ASA III or IV
Patients having pre eclampsia and cardiac or respiratory diseases, gestational and pre diabetes
Patient having IUGR, Fetal anomalies
Patient having abruptio placenta, placenta previa,accreta, percreta
Patients requiring emergency LSCS
Patient declining participation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of maternal hypotension in height - weight adjusted dose regimen group versus fixed dose group |
To note intraoperative vitals at 0,2,4,6,8,10,15,30,45,60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the time taken to achieve sensory level upto T6 level in both the groups
To assess the time taken to attain motor block according to Modified Bromage scale in both the groups
To assess dose of mephentermine used in both the groups
To assess the incidence of complications like hypotension, bradycardia, shivering, nausea, and vomiting in both the groups
To assess neonatal APGAR score at 1 and 5 mins in both the groups |
To note intraoperative vitals at 0,2,4,6,8,10,15,30,45,60 minutes |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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
|
To study the incidence of maternal hypotension in height-weight adjusted dosing regimen group versus fixed dosing group To assess the time taken for sensory block uoto T6 level, assess motor block according to Modified Bromage scale, to assess the dose of mephentermine used in both the groups, to assess the incidence of complications like hypotension, bradycardia, shivering, nausea, and vomiting , to assess neonatal APGAR scores at 1 and 5 minutes in both the groups |