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To see the effect of bolus/divided doses for spinal anaesthesia in caesarean section

Comparison of fractionated and bolus dose of bupivacaine and fentanyl to evaluate level of spinal anaesthesia in patients undergoing elective caesarean section

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020121
Enrollment
204
Registered
2019-07-09
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

None listed

Interventions

Intervention1: Group B
Bolus Group: Patient will receive Intrathecal Injection of 0.5% Hyperbaric Bupivacaine as Calculated +0.2ml of Fentanyl (10 mcg) as a Single Bolus Dose and kept in Same Position For 90 Seconds. Contro
Fractioned Group: Patients Group will recieve Intrathecal Injection of 0.5% Hyerbaric Bupivacaine as Calculated +0.2 ml of Fentanyl (10 mcg) with Two Third of Total Calculated Dose Given Initially Fol

Sponsors

Vardhman Mahavir Medical College and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (ASA) grade 1 & 2 patients scheduled for elective caesarean section, weighing between 50 to 110 kg and height between 140 cm to 180 cm, with a Singleton pregnancy >= 37 weeks will be included

Exclusion criteria

Exclusion criteria: 1 Inability of the patient to understand the procedure. 2 Contraindications to anaesthetic technique like patient refusal, local infection, coagulation abnormalities, history of allergic reaction to any of the drug to be used, sepsis, shock, spinal deformities, previous spinal surgeries, neurological disturbances, cardiac failure. 3 Pre-existing or Pregnancy Induced Hypertension. 4 Emergency Caesarean for foetal distress

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the level of block achieved with fractionated / bolus dose of bupivacaine with fentanyl for SAB in patients undergoing elective caesarean section.Timepoint: At end of 1,2,3,4,5,7,9,11,13,15 minute respectively.

Secondary

MeasureTime frame
To assess the hemodynamic changes (Hypotension) in the mother after giving subarachnoid block in both the group. To assess onset and duration of block in both the study group. To record and observe foetal outcome. Timepoint: At end of 1,2,3,4,5,7,9,11,13,15 minute respectively.

Countries

India

Contacts

Public ContactDr Rajeev Kumar

Vardhman Mahavir Medical College and Safdarjung Hospital

ameetaas@yahoo.com9811201585

Outcome results

None listed

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