RecruitingPhase 2NCT07465185

Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery

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


Sponsor

Benha University

Enrollment

300 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 35 Years

Inclusion Criteria1

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

Exclusion Criteria7

  • 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.

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Interventions

DRUGBupivacaine

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.

DRUGBupivacaine 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.


Locations(1)

Banha Faculity of Medicine

Banhā, Elqalyoubea,, Egypt

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NCT07465185


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