NCT07327866

Comparison of Classic and Sequential Spinal Techniques for Preventing Hypotension During Cesarean Delivery.

Incidence of Post-Spinal Anaesthesia Hypotension in Caesarean Delivery: A Randomized Trial of Classic Versus Sequential Spinal Technique

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Given the clinical importance of maternal hypotension, the potential advantages of sequential spinal dosing warrant formal evaluation in a prospective, adequately powered randomized controlled trial. We therefore designed this study to compare the incidence of post-spinal hypotension between the classic single-shot spinal and the sequential fractionated spinal techniques in elective cesarean delivery.

Conditions

• Caesarean Delivery
• Hypotension Postprocedural

Interventions

Type	Name	Description
PROCEDURE	Classic group	In the classic group, patients will receive a total intrathecal dose of 12.5 mg hyperbaric bupivacaine 0.5% (2.5 mL) combined with fentanyl 20 µg, administered as a single injection. Immediately after completion of the injection, the patient will be positioned supine with a 15° left lateral tilt to minimize aortocaval compression and facilitate uniform spread of the anesthetic solution.
PROCEDURE	Sequential group	In the sequential (fractionated) group, patients will receive the intrathecal dose in two fractions. While in the sitting position, the first fraction consisting of 7.5 mg (1.5 mL) of hyperbaric bupivacaine 0.5% combined with fentanyl 15 µg will be administered. After waiting for 60 seconds, the remaining 5 mg (1 mL) of hyperbaric bupivacaine and an additional 5 µg of fentanyl will be injected, either through the same intrathecal needle (if kept in place) or following careful reinsertion according to institutional practice. Immediately after completing the injection, the patient will be positioned supine with a 15° left lateral tilt to optimize maternal hemodynamics and ensure even distribution of the anesthetic solution.

Timeline

• Start date: 2026-01-28
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Egypt