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Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery

ConditionAnesthesia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorBenha University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Multiple pregnancies.

Cardiovascular disease(e.g., pre-eclampsia and hypertension).

Serious hepatic dysfunction (Child-Pugh class C).

serious renal dysfunction (undergoing dialysis before surgery).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Group (B)Active comparator 1 intervention
Group B: Group (BD)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

the duration of sensory block

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

Time frame
after anesthesia up to 12 hours postoperatively

Secondary outcomes

1

the onset time of sensory block

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

Time frame
during 30 minutes after intrathecal injection
2

the onset time of motor block

time taken from intrathecal injection to MBS \> 1

Time frame
during 30 minutes after intrathecal injection
3

The recovery quality of parturients

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

Time frame
24 hours post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov
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