CTRI

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CTRI Number

CTRI/2026/01/100438 [Registered on: 07/01/2026] Trial Registered Prospectively

Last Modified On:

07/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Research to identify how much norepinephrine safely keeps blood pressure stable during spinal anaesthesia for c section deliveries

Scientific Title of Study

Double blind randomised clinical trial to determine the effective bolus dose of norepinephrine in preventing spinal hypotension during caesarean delivery

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Pooja H S
Designation	MD Anaesthesia
Affiliation	KMCRI Hubli
Address	Department of Anaesthesiology Karnataka Institute of Medical Sciences Hubballi, Dharwad 580021 Karnataka, India Department of Anaesthesiology Karnataka Institute of Medical Sciences Hubballi, Dharwad 580021 Karnataka, India Dharwad KARNATAKA 580021 India
Phone	9731994109
Fax
Email	poojahspoo16@gmail.com

Details of Contact Person
Scientific Query

Name	DrBasavaraj Kallapur
Designation	Professor department of Ana
Affiliation	KMCRI Hubli
Address	Department of anaesthesia KMCRI Vijayanagar Hubli Dharwad KARNATAKA 580021 India
Phone	6364503729
Fax
Email	Doc_basu@yahoo.co.in

Details of Contact Person
Public Query

Name	DrBasavaraj Kallapur
Designation	Professor department of Ana
Affiliation	KMCRI Hubli
Address	Department of anaesthesia KMCRI Vijayanagar Hubli Dharwad KARNATAKA 580021 India
Phone	6364503729
Fax
Email	Doc_basu@yahoo.co.in

Source of Monetary or Material Support

Karnataka Institute of Medical Sciences Hubballi, Dharwad 580021 Karnataka, India

Primary Sponsor

Name	KIMS Hubballi
Address	Karnataka Institute of Medical Sciences Hubballi, Dharwad 580021 Karnataka, India
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Pooja H S	Karnataka Institute of Medical Sciences,Hubballi. Dharwad 580021	Department of Anaesthesiology Dharwad KARNATAKA	9731994109 poojahspoo16@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
KMCRI ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Parturients undergoing LSCS under spinal anaesthesia

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Norepinephrine 0.05 µg/kg bolus IV followed by infusion	Intravenous bolus of norepinephrine 0.05 µg/kg (1 µg/mL concentration in 10 mL 5% dextrose) administered immediately after intrathecal bupivacaine injection, followed by continuous infusion 0.05 µg/kg/min (8 µg/mL concentration) until delivery. Rescue: phenylephrine 40 µg IV boluses for hypotension.
Intervention	Norepinephrine 0.10 µg/kg bolus IV followed by infusion	Intravenous bolus of norepinephrine 0.10 µg/kg (2 µg/mL concentration in 10 mL 5% dextrose) administered immediately after intrathecal bupivacaine injection, followed by continuous infusion 0.05 µg/kg/min (8 µg/mL concentration) until delivery. Rescue: phenylephrine 40 µg IV boluses for hypotension.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	45.00 Year(s)
Gender	Female
Details	1) Parturients undergoing elective/emergency caesarean birth under spinal anaesthesia. 2).Full term singleton gestation. 3).American Society of Anaesthesiology Physical Status score of II.

ExclusionCriteria

Details

1) History of hypertension or cardiovascular disease.

2) Severely impaired liver or kidney function.

3) Coagulation abnormalities.

4) Patients on anti platelet and anticoagulant agents.

5) Fetal abnormality.

6) History of epilepsy.

7) Patients who do not give consent.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Incidence of spinal hypotension, defined as systolic blood pressure decrease to 80% of baseline between initiation of intrathecal injection and delivery.	From initiation of intrathecal bupivacaine injection until delivery of baby

Secondary Outcome

Outcome	TimePoints
Frequency of hypertension & severe spinal hypotension Rescue drug administered from the time of subarachnoid block to the delivery Frequency of bradycardia Incidence of maternal nausea or vomiting Duration of hypotension	From initiation of intrathecal bupivacaine injection till the uterine closure

Target Sample Size

Total Sample Size="130"
Sample Size from India="130"
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)

19/01/2026

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="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

This randomized double-blind clinical trial aims to determine the effective bolus dose of norepinephrine to prevent spinal hypotension during cesarean delivery, a common complication of spinal anesthesia. Norepinephrine, with its strong alpha agonist and mild beta agonist activity, offers better hemodynamic stability compared to ephedrine and phenylephrine. A total of 130 term parturients aged 20–45 years (ASA II) undergoing elective or emergency cesarean section at KIMS, Hubli, will be randomized into two groups to receive either 0.05 mcg per kg or 0.10 mcg per kg norepinephrine bolus followed by a fixed-rate infusion. Maternal blood pressure, heart rate, need for rescue drugs, and adverse effects such as bradycardia, nausea, and vomiting will be recorded. The primary outcome is the incidence of spinal hypotension, and secondary outcomes include severity of hypotension, hypertension episodes, rescue drug usage, and hemodynamic changes. Data will be analyzed using SPSS with significance at p less than 0.05.