Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery

Hospital Central Dr. Luis Ortega

Status and phase: Completed; Phase 4

Conditions: Dexmedetomidine in Subarachnoidal Anesthesia

Treatments: Drug: Fentanyl and bupivacaine; Drug: Dexmedetomidine and bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02582372

HCLuisOrtega

Details and patient eligibility

About

Dexmedetomidine, highly selective agonist for alpha-2 receptors, enhances the sensory and motor block with prolonged postoperative analgesia without hemodynamic compromise.

OBJECTIVE: To evaluate effects of dexmedetomidine vs fentanyl with hyperbaric bupivacaine spinal anesthesia for lower abdominal surgeries.

METHODS: double-blind, randomized, American Society Anesthesiologist classification (ASA) : I - II, 18-65 years. F group (23 patients) received 25 mcg fentanyl, Group D (27 patients), 10 mcg dexmedetomidine with 12.5 mg hyperbaric bupivacaine . 0,02mgrs morphine / kg intravenously if EVA≥4was administered in postoperative period. Hemodynamic variables and O2 saturation intraoperatively was recorded, EVA every 4 hours, side effects, sensory block, motor, sedation and peripheral neurological manifestations of toxicity.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I and II
• lower abdominal surgery

Exclusion criteria

• Consumption antagonists adrenergic or channel blockers Ca ++
• Patients with arrhythmias or heart block
• Allergic to any drugs under study
• Obese
• Physical or mental incapacity to understand and use the pain scale
• Contraindication for anesthesia conductive
• Realization difficulty or complication during anesthesia and / or surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

dexmedetomidine

Experimental group

Description:

25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge

Treatment:

Drug: Dexmedetomidine and bupivacaine

fentanyl

Active Comparator group

Description:

25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge

Treatment:

Drug: Fentanyl and bupivacaine