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Recruiting NCT07465185

Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery

Phase II Interventional Anesthesia

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: Bupivacaine, Bupivacaine and Dexmedetomidine.
Who it may be relevant to
Registry conditions: Anesthesia. Basic parameters: 20 years — 35 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 →

Unsure about the terms? Read our patient guide →

Official title

Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery ;Arandomized Non - Inferiority Study

Overview

Cesarean section (CS) is one of the most frequently performed surgical procedures globally, with an increasing demand for safe and effective anesthesia techniques. Regional anesthesia, particularly intrathecal anesthesia, has become the method of choice for elective cesarean deliveries.The most commonly used local anesthetic for intrathecal anesthesia is bupivacaine.Recent studies have focused on adjunctive agents to enhance the efficacy of local anesthetics.

Interventions

  • Drug Bupivacaine
    patient will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml.
  • Drug Bupivacaine and Dexmedetomidine
    patient will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml.

Primary outcome measures

  • the duration of sensory block [Time frame: after anesthesia up to 12 hours postoperatively]
Secondary outcome measures (3)
  • the onset time of sensory block [Time frame: during 30 minutes after intrathecal injection]
  • the onset time of motor block [Time frame: during 30 minutes after intrathecal injection]
  • The recovery quality of parturients [Time frame: 24 hours post-operatively]

Eligibility criteria

Inclusion criteria

  • (1) Full-term pregnant women undergoing elective cesarean section under spinal anesthesia. (2) Age: 20 \~ 35 years. (3) ASA physical status II \~ III

Exclusion criteria

  • Multiple pregnancies.
  • Cardiovascular disease(e.g., pre-eclampsia and hypertension).
  • Serious hepatic dysfunction (Child-Pugh class C).
  • serious renal dysfunction (undergoing dialysis before surgery).
  • History of alcohol or opioid addiction.
  • Contraindication to spinal anesthesia.
  • Refusing 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
Triple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Banha Faculity of Medicine — Banhā

Identifiers

NCT: NCT07465185 · RC 17-2-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗