| CTRI Number |
CTRI/2026/01/102166 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of three different bolus doses of Norepinephrine for preventing low blood pressure during Spinal Anaesthesia for caesarean delivery.
A Randomized Clinical Trial |
|
Scientific Title of Study
|
Effects of three different bolus doses of Norepinephrine for preventing Hypotension during Spinal Anaesthesia for caesarean delivery.
A Randomized Clinical 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 |
Deepali Srivastava |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Regional institute of Medical Sciences
Imphal
Manipur Imphal
Manipur Imphal West MANIPUR 795004 India |
| Phone |
9027671298 |
| Fax |
|
| Email |
doctordeepali.68@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Takhelmayum Hemjit singh |
| Designation |
Professor |
| Affiliation |
Regional institute of medical sciences |
| Address |
Department of Anaesthesia
Regional institute of Medical Sciences
Imphal
Manipur Department of Anaesthesia
Regional institute of Medical Sciences
Imphal
Manipur Imphal West MANIPUR 795004 India |
| Phone |
9436021445 |
| Fax |
|
| Email |
takhelhem@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Deepali Srivastava |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Regional Institute of Medical Sciences
Imphal
Manipur Imphal
Manipur Imphal West MANIPUR 795004 India |
| Phone |
9027671298 |
| Fax |
|
| Email |
doctordeepali.68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Regional Institute Of Medical Sciences
Imphal west
Manipur
795004 |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Regional Institute of Medical Sciences
Imphal west
Manipur |
| 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 Deepali Srivastava |
Regional Institute Of Medical Sciences |
Modular OT Complex
Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal west Imphal West MANIPUR |
9027671298
doctordeepali.68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board ,RIMS imphal |
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 |
Norepinephrine 10 Micrograms |
Study participants will receive 10 micrograms of norepinephrine in case of hypotension induced during spinal anaesthesia for cesarean delivery.Duration of surgery is 45-90 minutes |
| Comparator Agent |
Norepinephrine 5 microgram |
Study participants will receive 5 micrograms of norepinephrine in the event of hypotension induced during spinal anaesthesia for caesarean delivery.Duration of surgery is approximately 45 to 90 minutes |
| Comparator Agent |
Norepinephrine 8 micrograms |
Study participants will receive 8 micrograms of norepinephrine in case of hypotension induced during spinal anaesthesia for cesarean delivery.Duration of surgery is approximately 45 to 90 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
AMERICAN SOCIETY OF ANAESTHESIOLOGISTS(ASA) PHYSICAL STATUS GRADE I OR II.
PATIENTS UNDERGOING ELECTIVE CAESAREAN DELIVERY |
|
| ExclusionCriteria |
| Details |
1 History of allergy to local anaesthetic agent and or study drugs
2 Bleeding disorders like Von Willebrand disease Idiopathic Thrombocytopenic purpura platelet count less than 50000 per microlitre
prothrombin time less than 14 seconds
International normalised ratio INR less than 1.5
3 Local site infection mainly spine
4 Spinal deformity
5 Cardiac respiratory diseases and kidney disorder and neurological deficit
6 Parturient with Pre eclamptic toxaemia or any hypertensive disorder
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the optimal bolus doses of norepinephrine in management of spinal hypotension in elective caesarean section |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the hemodynamic parameters like Systolic blood pressure (SBP) Mean arterial pressure (MAP) Diastolic blood pressure (DBP) & heart rate (HR) at varied time interval after administration of norepinephrine & also the foetal cord blood acid base study at delivery & after 5 minutes
Adverse effects like giddiness, nausea &vomiting.
|
At baseline & After 5 minutes till 90 minutes |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
15/02/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [doctordeepali.68@gmail.com].
- For how long will this data be available start date provided 20-12-2025 and end date provided 20-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Spinal anaesthesia is the most common preferred type of
anaesthesia in elective caesarean section. But hypotension following spinal
anaesthesia is a common and dreadful complication. Use of non-pharmacological
methods are not found to be effective, hence use of vasopressor is indicated in
management of hypotension. Among vasopressors norepinephrine is a drug which
manages hypotension as well as maintains the hemodynamic parameters of the
parturient.
Here in our study we would find out the optimal dosage of
norepinephrine bolus for management of spinal hypotension by recording the
incidence of successful
treatment of hypotension which is considered when systolic blood pressure
increases by 20 percent within 2 minutes of the administration
of different regimens of norepinephrine bolus. We will also try to find which
regimen provides better hemodynamic stability and fetal outcome with least
adverse reactions.
A total of 150 parturient aged 18 to 45 years belonging to
American society of Anaesthesiologists ASA I and II undergoing lower segment
caesarean section under spinal anaesthesia will be divided into three groups of Group A Group B and Group C by block randomization. Group A patients will
receive norepinephrine 5 microgram as intravenous bolus group B patients will receive
norepinephrine 8 microgram as intravenous bolus group C patients will receive
norepinephrine 10 microgram as intravenous bolus whenever
the systolic blood pressure fall below 20 percent from the baseline. The incidence of successful treatment of hypotension in
each group will be noted. The number of occurrences of hypotension before
delivery and after delivery will be also be recorded. Hemodynamic parameters
will be monitored and recorded. The baseline values will be compared with the
values obtained after spinal block in all the three groups. The incidence of
bradycardia hypertension and foetal outcome such as Apgar score and umbilical
vein blood gases will also be recorded.
The findings and observations made during the entire study
will be tabulated graphically depicted whenever possible statistically
analysed and inference will be drawn. |