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Which of the two doses of norepinephrine (a drug to increase blood pressure) will better prevent hypotension (decrease in blood pressure) in pregnant women following spinal anesthesia undergoing emergency c-section?

Comparison of two doses of norepinephrine infusion for prophylaxis of maternal hypotension following spinal anaesthesia in pregnant women undergoing emergency c-section: a two arm, double blind randomised control trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069181
Enrollment
164
Registered
2024-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O295- Other complications of spinal andepidural anesthesia during pregnancy

Interventions

Intervention1: Infusion of norepinephrine at 0.050mcg per min per kg body weight: 1 ampoule of 2 ml contains 4 mg norepinephrine tartrate equivalent to 2 mg noerepinephrine base(2:2). Take 2 such ampo

Sponsors

All India Institute of Medical Sciences, Bihar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Labouring and non-labouring pregnant women with period of gestation more than 37 weeks undergoing category II caesarean section. Non-reassuring cardiotocography (CTG) including anyone of the following- Fetal heart rate(FHR) as per RCOG guidelines (FHR 100-109bpm or 161-180bpm). Variability less than 5bpm for more than 40minutes but less than 90 minutes. Early deceleration. Variable deceleration. Single prolonged deceleration less than 90 seconds

Exclusion criteria

Exclusion criteria: Complications such as hypertensive disorders of pregnancy, cardiovascular or cerebrovascular disease, multiple gestation, known fetal abnormality. Hemodynamically unstable or baseline SBP less than 100 mmHg. ASA physical status 3 or more than 3. Severely compromised fetus who requires immediate administration of general anaesthesia. Presence of contra-indications for spinal anaesthesia. Participants who have received labour analgesia.

Design outcomes

Primary

MeasureTime frame
To assess frequency of post-spinal hypotension, intra-operative bradycardia, intra-operative hypertension.Timepoint: maternal heart rate and blood pressure will be taken at 2 minute interval from before intrathecal injection until the delivery of the fetus.

Secondary

MeasureTime frame
Presence of fetal acidosis APGAR score NICU admission Intra-operative nausea and vomiting Total number of norepinephrine boluses given Total dose of norepinephrine given Duration of NICU stay Time between skin incision and delivery of the foetusTimepoint: APGAR score at 1 minute and 5 minute NICU admission within 24 hours of delivery

Countries

India

Contacts

Public ContactDr Chandni Sinha

AIIMS PATNA

chandni.doc@gmail.com7250333148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026