Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section

Menoufia University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cesarean Section; Dexmedetomidine; Spinal Anesthesia

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03775655

9076411

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Full-term pregnant women
• Singleton gestation
• American Society of Anaesthesiologists (ASA) physical status classes II and I

Exclusion criteria

• Preterm pregnancy (<37 wks. gestation)
• Multiple gestation
• Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications
• Asthma and allergy to non-steroidal anti-inflammatory drugs
• Conditions that prevent spinal anaesthesia
• Failed spinal block and conversion to general anaesthesia
• A history of established chronic pain
• Drug addiction
• A psychiatric disorder
• Inability to communicate effectively

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

LD-DEX

Active Comparator group

Description:

This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml).

Treatment:

Drug: Dexmedetomidine

Control group

No Intervention group

Description:

This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%).