Skip to content

Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07465185
Enrollment
300
Registered
2026-03-11
Start date
2026-03-15
Completion date
2026-10-15
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

bupivacaine, dexmetomedine, spinal anesthesia, cessarian delivery

Brief 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.

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.

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.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the duration of sensory blockafter anesthesia up to 12 hours postoperativelytime taken from intrathecal injection to sensory regression to S1 dermatome.

Secondary

MeasureTime frameDescription
the onset time of sensory blockduring 30 minutes after intrathecal injectiontime taken from intrathecal injection to the maternal feeling of lower extremities temperature increment or numbness
the onset time of motor blockduring 30 minutes after intrathecal injectiontime taken from intrathecal injection to MBS \> 1
The recovery quality of parturients24 hours post-operativelyObsQoR-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

Countries

Egypt

Contacts

CONTACTfatma ahmed abdelfatah, MD
drfatmaahmed86@gmail.com00201091921540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026