A study comparing technique of spinal anesthesia injection for mothers undergoing cesarean operation to deliver babies- one by giving whole medicine at once and the other by giving half of the medicine at first and then giving the rest after 45 seconds and then check stability of blood pressure

A Comparison of the Effects of Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine (0.5%) in Spinal Anaesthesia for Parturients undergoing Elective Caesarean Section: A Randomised, Double Blind Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078466

Enrollment

100

Registered

2024-12-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: 1- Obstetrics

Interventions

Intervention1: Fractionated spinal dose for hyperbaric bupivacaine: the group F parturients will receive Fractionated dose with half of Total calculated dose of Hyperbaric Bupivacaine (0.5%) administe

Eligibility

Inclusion criteria

Inclusion criteria: 1. Having ASA grade II . 2. Aged between 18 to 35 years. 3. Giving valid consents. 4. With singleton pregnancies undergoing Elective Caesarean Section under Spinal Anaesthesia.

Exclusion criteria

Exclusion criteria: Parturients - 1. Not giving valid consent for Study or Spinal anaesthesia. 2. With severe cardio-respiratory disease. 3. With hepatic & renal disease. 4. With neurologic disorder or raised ICP. 5. With known endocrine disorder. 6. With psychiatric problems. 7. Having Coagulation disorder. 8. Having Spinal Deformity or Local infection at the site of injection. 9. With H/O allergy to study drugs

Design outcomes

Primary

Measure	Time frame
Hemodynamic Stability in terms of Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial pressureTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr	—

Secondary

Measure	Time frame
SpO2 %Timepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;ECG, ST changesTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Level of sensory block and duration of sensory blockTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Degree of motor block and duration of motor blockTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Incidence of hypotension & Requirement of total dose of vasopressorTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Incidence of side effects if anyTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Neonatal outcome by Apgar scoreTimepoint: 1 min,5 min after birth;Respiratory rateTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr	—

Measure

Time frame

SpO2 %Timepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;ECG, ST changesTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Level of sensory block and duration of sensory blockTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Degree of motor block and duration of motor blockTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Incidence of hypotension & Requirement of total dose of vasopressorTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Incidence of side effects if anyTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr;Neonatal outcome by Apgar scoreTimepoint: 1 min,5 min after birth;Respiratory rateTimepoint: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr

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Countries

India

Contacts

Public ContactDr SOMNATH DE

Midnapore Medical College & Hospital

licimed@gmail.com9477038017

Outcome results

None listed

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