Spinal bupivacaine with or without dexmedetomidine for cesarean delivery
Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery ;Arandomized Non - Inferiority Study
This trial tests whether adding dexmedetomidine to spinal bupivacaine improves anesthesia for full-term women having elective cesarean deliveries.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, Elqalyoubea,) |
| Trial ID | NCT07465185 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial enrolls full-term pregnant women aged 20–35, ASA II–III, who are scheduled for elective cesarean delivery under spinal anesthesia. Participants receive intrathecal bupivacaine alone or bupivacaine combined with dexmedetomidine, and investigators compare anesthetic characteristics and safety between the two approaches. Outcomes of interest include block onset and duration, hemodynamic stability, analgesic requirements, and side effects in the perioperative period. The protocol excludes women with multiple pregnancy, significant cardiovascular, hepatic or renal disease, substance addiction, or contraindications to spinal anesthesia.
Who should consider this trial
Good fit: Full-term pregnant women aged 20–35 with ASA physical status II–III who are scheduled for elective cesarean delivery under spinal anesthesia and meet inclusion/exclusion criteria.
Not a fit: Women with multiple pregnancies, significant cardiovascular disease (including pre-eclampsia or hypertension), severe hepatic or renal dysfunction, a history of substance addiction, contraindications to spinal anesthesia, or those who decline consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding dexmedetomidine could provide longer or more stable spinal anesthesia with improved pain control and acceptable safety for cesarean deliveries.
How similar studies have performed: Previous smaller studies of intrathecal dexmedetomidine as an adjuvant to local anesthetics have reported longer block duration and improved analgesia in some settings, but evidence in cesarean populations remains limited.
Eligibility criteria
Show full inclusion / exclusion 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: 1. Multiple pregnancies. 2. Cardiovascular disease(e.g., pre-eclampsia and hypertension). 3. Serious hepatic dysfunction (Child-Pugh class C). 4. serious renal dysfunction (undergoing dialysis before surgery). 5. History of alcohol or opioid addiction. 6. Contraindication to spinal anesthesia. 7. Refusing to sign informed consent.
Where this trial is running
Banhā, Elqalyoubea,
- Banha Faculity of Medicine — Banhā, Elqalyoubea,, Egypt (Recruiting)
Study contacts
- Study coordinator: fatma ahmed abdelfatah, MD
- Email: drfatmaahmed86@gmail.com
- Phone: 00201091921540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.