| CTRI Number |
CTRI/2024/03/063948 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs inj mephenteramine and inj norepinephrine for the prophylaxis of hypotension in cesarean section after spinal anesthesia. |
|
Scientific Title of Study
|
Randomised controlled trial to study comparison between prophylactic bolus doses of norepinephrine and mephenteramine on hypotension after spinal anesthesia for cesarean section. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harivart kaushik |
| Designation |
DNB Anesthesia |
| Affiliation |
Northern railway central hospital |
| Address |
OT complex, department of anaesthesiology, northern railway central hospital
Northern railway central hospital, Basant lane, New Delhi, 110055
New Delhi
DELHI
110055
India |
| Phone |
8460125099 |
| Fax |
|
| Email |
harivartkaushik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta chadha |
| Designation |
Head of department ,Dept. of anaesthesiology |
| Affiliation |
Northern railway central hospital |
| Address |
Department of Anesthesia, northern railway central hospital, Paharganj, New Delhi 110055
Northern railway central hospital, Basant lane, New Delhi 110055
New Delhi
DELHI
110055
India |
| Phone |
9717630526 |
| Fax |
|
| Email |
mamtachadha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta chadha |
| Designation |
Head of department ,Dept. of anaesthesiology |
| Affiliation |
Northern railway central hospital |
| Address |
Department of Anesthesia, northern railway central hospital, Paharganj, New Delhi 110055
Northern railway central hospital, Basant lane, New Delhi 110055
New Delhi
DELHI
110055
India |
| Phone |
9717630526 |
| Fax |
|
| Email |
mamtachadha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Northern railway central hospital, new delhi |
|
|
Primary Sponsor
|
| Name |
Northern railway central hospital |
| Address |
Basant Lane, Aram Bagh, Connaught Place, Paharganj, New Delhi, Delhi 110055 |
| 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 |
| Dr Harivart Kaushik |
Northern railway central hospital |
OT complex, Anesthesia Department , northern railway central hospital,New Delhi 110055
New Delhi
DELHI |
8460125099
Harivartkaushik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, northern railway central hospital, IEC-NRCH |
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 |
| Comparator Agent |
Inj mephenteramine bolus dose given iv after spinal Anesthesia for prophylaxis of hypotension |
6mg bolus given iv just after spinal Anesthesia and as and when required |
| Intervention |
Inj norepinephrine bolus dose given iv after spinal Anesthesia in LSCS for prophylaxis of hypotension |
8microg bolus dose, intravenous, just after spinal and as and when required |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Singleton, uncomplicated pregnancy undergoing LSCS under Spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1 Pre eclampsia. 2 Multiple preganancy 3 Patients with operated spine. 4. ASA grade 3 or greater 5. Known allergy to study drug 6. Those who required respinal because of the failure of the ist one |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of incidence of hypotension which MAP less than 80% of baseline and incidence of bradycardia which is HR less than 60per minute among Group A and Group B |
After spinal Anesthesia at 0 mins and after every 2 mins till 14 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of effects of drugs on cord blood ph, and incidence of maternal nausea and vomiting ,headache among group A and B |
During the duration of LSCS |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| 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="10"
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 the study is to compare the equipotent doses of inj norepinephrine 8 micrograms and mephenteramine 6 mg for the prophylaxis of hypotension in LSCS after spinal Anesthesia. The subject and the anesthetist giving the drug will be blinded to the drug which will be given. Pregnant females aged between 18 to 45 years with single pregnancy without any comorbidity will be taken into study only after their consent. Patients with allergy to study drugs, multiple pregnancy,having any contraindication to spinal Anesthesia will be excluded from the study. Patient will be taken on the table after checking vitals spinal will be given to the patient and just after making the patient supine bolus dose of the drug will be given and NIBP and HR will be measured at 0,2,4,6,8,10,12,14 mins. Other complains like nausea ,vomiting, headache will also be checked during the duration of LSCS Patient will be monitored postoperatively. |