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Not yet recruiting NCT07327866

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

Phase III Interventional Caesarean Delivery Hypotension Postprocedural

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Classic group, Sequential group.
Who it may be relevant to
Registry conditions: Caesarean Delivery, Hypotension Postprocedural. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 accordi

Primary outcome measures

  • Incidence of post-spinal hypotension [Time frame: Assessed during the first 15 minutes after the intrathecal injection.]
Secondary outcome measures (7)
  • Time to first hypotensive episode [Time frame: Measured continuously for 15 minutes following the intrathecal injection.]
  • Number of hypotensive episodes [Time frame: Assessed within 15 minutes after intrathecal injection.]
  • Total vasopressor dose [Time frame: Assessed within 15 minutes after spinal administration.]
  • Maximal sensory block level and time to T4 [Time frame: Evaluated from injection until block stabilization within 20 minutes.]
  • Maternal nausea and vomiting [Time frame: Monitored intraoperatively up to delivery.]
  • Maternal satisfaction [Time frame: Assessed after delivery before discharge from recovery.]
  • Neonatal outcomes (Apgar scores and umbilical artery pH) [Time frame: Determined immediately after delivery (Apgar at 1 and 5 minutes; pH from cord sample at birth).]

Eligibility criteria

Inclusion criteria

  • Adult women aged 18-45 years.
  • ASA physical status II-III.
  • Scheduled for elective cesarean section under standardized spinal anesthesia.

Exclusion criteria

  • Allergy to local anesthetics.
  • Emergency cesarean section.
  • Contraindication to spinal anesthesia (e.g., coagulopathy, infection at the puncture site).
  • Preexisting hypertension on medication or pre-eclampsia with severe features.
  • Known cardiac disease accompanied by hemodynamic instability.
  • Allergy to study drugs.
  • Fetal distress or non-reassuring cardiotocography (CTG).
  • BMI >40 kg/m².
  • Refusal to sign informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Al-Azhar University — Cairo

Identifiers

NCT: NCT07327866 · RC. 16.10.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗