| CTRI Number |
CTRI/2022/04/041776 [Registered on: 11/04/2022] Trial Registered Prospectively |
| Last Modified On: |
10/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To decrease the side effects of spinal anaesthesia using different doses of drugs in Caesarean section |
|
Scientific Title of Study
|
Comparitive study of fixed dose versus height adjusted dose of heavy bupivacaine in spinal anaesthesia for elective caesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Piu Gorai |
| Designation |
Junior Resident |
| Affiliation |
RIMS,Ranchi |
| Address |
Department of Anaesthesiology,RIMS,Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
8092760437 |
| Fax |
|
| Email |
mepiugorai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ekramul Haque |
| Designation |
Associate Professor |
| Affiliation |
RIMS,Ranchi |
| Address |
Department of Anaesthesiology, RIMS,Ranchi, Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
8210696628 |
| Fax |
|
| Email |
ekramrims@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ekramul Haque |
| Designation |
Associate Professor |
| Affiliation |
RIMS,Ranchi |
| Address |
Department of Anaesthesiology,
RIMS,Ranchi,Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
8210696628 |
| Fax |
|
| Email |
ekramrims@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, RIMS,Ranchi |
| 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 Piu Gorai |
RIMS,Ranchi |
Department of Anaesthesiology, RIMS,Ranchi
Ranchi
JHARKHAND |
8092760437
mepiugorai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajendra Institute of Medical Sciences,Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fixed dose group |
Patient to recieve fixed dose 11mg(2.2ml) of 0.5% heavy bupivacaine intrathecally via spinal needle at the time of induction before caesarean section |
| Intervention |
Height based group |
Patients to recieve height adjusted dose(0.06mg/cm) of 0.5% heavy bupivacaine intrathecally via spinal needle at the time of induction before caesarean section |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient consent
2.Age group - 21years to 40years scheduled for elective caesarean section
3.singleton pregnancy
4.Weight -40 to 80 kg
5.Height- 140cm-170cm
5.ASA II |
|
| ExclusionCriteria |
| Details |
1.patient refusal
2.patient with contraindication to spinal anaesthesia
3.patient with cardiovascular disease,pre eclampsia,eclampsia and systolic BP<90 mmHg
4.Women with fetal abnormalities
5.women with placental abnormalities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Incidence of maternal hypotension
2.Time to reach T8 sensory level
3.Maximum sensory level achieved and time to reach the same
4.Time taken for 2 segment sensory regression
5.Time to achieve modified bromage score 3
|
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total dose of mephentermine consumption
2.APGAR score at 1 and 5 min
3.To study side effects such as nausea, vomiting ,headache |
24 hrs |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/04/2022 |
| 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="1"
Months="6"
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 is randomized double blind parallel group trial comparing height based optimization (0.06mg/cm) Vs fixed 11 mg/2.2 ml)of heavy bupivacaine in spinal anaesthesia for patients posted for elective caesarean section in RIMS Ranchi in INDIA.THE Primary objective is to study incidence of hypotension and block characteristics.The secondary objective is to study the total dose of mephentermine consumption and side effects.Inclusion criteria included singleton, uncomplicated pregnancy of ASA physical status II.The hypothesis of the study is height based optimization of dose of bupivacaine will minimize hypotension and would provide adequate anaesthesia for caesarean section.Various studies such as Huang B,Huang Q found that height adjusted dose of spinal anaesthesia in parturient provides sufficient anaesthesia and low incidence of maternal hypotension and that prophylactic fliluid preloading and vasopressor are unnecessary. Sabale P et al found that height based dose of spinal anaesthesia decreases the chance of hypotension,need of vasopressor with better hemodynamic stability and decreased incidence of side effects |