| CTRI Number |
CTRI/2024/06/069444 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
For cesarean section height adjusted dose of bupivacaine and fixed dose of bupivacaine is used for spinal anaesthesia -which one is better for reducing incidence of hypotension |
|
Scientific Title of Study
|
Comparison of incidence of hypotension in height adjusted dose vs fixed dose of bupivacaine in spinal anesthesia in cesarean section: A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratima |
| Designation |
Resident doctor |
| Affiliation |
Dr SN Medical college, Jodhpur |
| Address |
Dept of anaesthesia,Dr SN medical college, Jodhpur, Rajasthan 342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
7726952940 |
| Fax |
|
| Email |
miracleprt27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fateh Singh Bhati |
| Designation |
Senior professor |
| Affiliation |
Dr SN medical college |
| Address |
Department of anaesthesia and critical care, Dr SN medical college, Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fateh Singh Bhati |
| Designation |
Senior professor |
| Affiliation |
Dr SN medical college |
| Address |
Department of anaesthesia and critical care, Dr SN medical college, Jodhpur
RAJASTHAN
342001
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN medical college Jodhpur , Residency road, sector D, Shastri nagar, Jodhpur,Rajasthan 342001, India |
|
|
Primary Sponsor
|
| Name |
Dr SN medical college Jodhpur |
| Address |
Dr SN medical college Jodhpur , Residency road, sector D, Shastri nagar, Jodhpur,Rajasthan 342001, India |
| 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 Pratima |
Umaid and Janana MDM hospital |
Operation theatre first floor dept of anaesthesia umaid hospital Siwanchi gate road,Pratap nagar Jodhpur and
Janana wing OT MDM hospital Dept of anaesthesia Dr SN medical college Jodhpur
Jodhpur
RAJASTHAN |
7726952940
miracleprt27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Dr SN medical college Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patient undergoing cesarean section receiving height adjusted dose of bupivacaine heavy for spinal anaesthesia |
Comparing incidence of hypotension in height adjusted dose (0.06mg/cm) 0.5% bupivacaine heavy and fixed dose 2ml(10mg) of 0.5% bupivacaine heavy in spinal anaesthesia intrathecally in cesarean section |
| Comparator Agent |
Patient undergoing spinal anaesthesia for cesarean section receiving fixed dose bupivacaine heavy for spinal anaesthesia |
Comparing incidence of hypotension in height adjusted dose (0.06mg/cm) 0.5% bupivacaine heavy and fixed dose 2ml(10mg) of 0.5% bupivacaine heavy in spinal anaesthesia intrathecally in cesarean section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Age more than 18 yrs
ASA1,2
Elective cesarean section
Singleton pregnancy more than 37weeks
Uncomplicated pregnancy |
|
| ExclusionCriteria |
| Details |
Presenting with any systemic illness
Emergent surgery and labouring parturients
Multiple or twin pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension in height adjusted dose of 0.5% heavy bupivacaine (0.06mg/cm) in cesarean section under spinal anaesthesia compared to fixed dose 2ml(10mg) 0.5% heavy bupivacaine in cesarean section under spinal anaesthesia in control group |
Blood pressure reading will be monitored once before spinal anaesthesia then after spinal anaesthesia every 1 min for 10 mins, every 5mins till 30 mins then every 10 mins till end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of nausea and vomiting in each group |
After spinal anaesthesia till end of surgery |
| Intraoperative fluid requirement |
After spinal anaesthesia till end of surgery |
| Cumulative dose of vasopressor(ephedrine) required |
After spinal anaesthesia till the end of surgery |
| Extent of surgical anaesthesia in each group |
Time to achieve T6 level of sensory block and highest level of sensory block will be noted after administration of drug.
Time to achieve bromage score 1 and time to achieve maximum level(bromage score 3) for motor block after drug administration will be noted. |
| Other complications if any |
After intrathecal drug administration in each group |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="6"
Days="0" |
|
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
|
The aim of this study is to compare incidence of hypotension in one group receiving height adjusted dose of heavy bupivacaine 0.5%(0.06mg/cm) with other group receiving fixed dose of heavy bupivacaine 0.5% in parturients for cesarean section under spinal anaesthesia. Following is also compared in each group: Incidence of nausea and vomiting Intraoperative fluid requirement Cumulative dose of vasopressor used Extent of surgical anaesthesia Other complications if any (bradycardia,dyspnea) |