A clinical trail to prevent the incidence of hypotension after spinal anesthesia in cesarean section with leg wrapping, nor adrenaline infusion and combination of both.

A prospective randomized control trial for prevention of postspinal hypotension with noradrenaline infusion, leg wrapping and combination of both in cesarean section under spinal anaesthesia.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036534

Enrollment

105

Registered

2021-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Noradrenaline infusion and leg wrapping: Leg wrapping before intrathecal block and Noradrenaline infusion at 0.025mcg/kg/min intravenously after the intrathecal block. Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Age 19-40 years parturient with singleton pregnancy undergoing elective cesarean sections. American Society of Anesthesia (ASA) physical status:1 and 2. Informed, written and valid consent by parturients or relatives.

Exclusion criteria

Exclusion criteria: Parturient with allergy or hypersensitivity to norepinephrine BMI >35kg/m2 With hypertensive disorders of pregnancy With preexisting hypertension With cardiovascular disease With cerebrovascular disease With fetal abnormalities

Design outcomes

Primary

Measure	Time frame
To assess the incidence of hypotension.Timepoint: Blood pressure will be monitored 1st minute and then every 2 minute till the delivery of the baby and thereafter every 5 minute till the end of the surgery	—

Secondary

Measure	Time frame
1.The incidence of hypertension, tachycardia, bradycardia. 2. The need of rescue vasopressor (ephedrine) 3. Onset of sensory and motor blockade. 4. The incidence of maternal nausea and vomiting. 5. Fetal outcome as APGAR score.Timepoint: Blood pressure and heart rate will be monitored 1st minute and then every 2 min till delivery of baby and thereafter every 5 min till the end of surgery The highest level of sensory blockade achieved will be assessed with pin prick 5 minute after intrathecal injection. The motor blockade achieved will be assessed by Modified bromage scale after 5 mins of intrathecal block Fetal well being will be assessed by APGAR Score at 1 and 5 mins	—

Measure

Time frame

1.The incidence of hypertension, tachycardia, bradycardia. 2. The need of rescue vasopressor (ephedrine) 3. Onset of sensory and motor blockade. 4. The incidence of maternal nausea and vomiting. 5. Fetal outcome as APGAR score.Timepoint: Blood pressure and heart rate will be monitored 1st minute and then every 2 min till delivery of baby and thereafter every 5 min till the end of surgery The highest level of sensory blockade achieved will be assessed with pin prick 5 minute after intrathecal injection. The motor blockade achieved will be assessed by Modified bromage scale after 5 mins of intrathecal block Fetal well being will be assessed by APGAR Score at 1 and 5 mins

—

Countries

India

Contacts

Public ContactDr Jyothi B

Karnataka institute of medical sciences

dr.jyothib1@gmail.com9886187056

Outcome results

None listed

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