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NCT Number: NCT07465185

Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery

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.

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Key information

Conditions

Anesthesia

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Banha Faculity of Medicine

Banhā, Elqalyoubea,, 13511, Egypt

Location status: Recruiting

Location contact

fatma ahmed abdelfatah, MD

CONTACT

[email protected]

00201091921540

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine

Drug

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.

Bupivacaine and Dexmedetomidine

Drug

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 outcomes

  1. the duration of sensory block

    Time frame: after anesthesia up to 12 hours postoperatively

    time taken from intrathecal injection to sensory regression to S1 dermatome.

Secondary outcomes

  1. the onset time of sensory block

    Time frame: during 30 minutes after intrathecal injection

    time taken from intrathecal injection to the maternal feeling of lower extremities temperature increment or numbness

  2. the onset time of motor block

    Time frame: during 30 minutes after intrathecal injection

    time taken from intrathecal injection to MBS > 1

  3. The recovery quality of parturients

    Time frame: 24 hours post-operatively

    ObsQoR-11, score from 0 to 10 in each term, where 0 = strongly agree and 10 = strongly disagree, the higher of the score, the higher of recovery quality

Study contacts

Contact information is provided by the study sponsor or research team.

fatma ahmed abdelfatah, MD

CONTACT

[email protected]

00201091921540

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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