drugset / Trial / NCT02582372

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

NCT02582372 ↗

Phase 4 Completed 50 enrolled Hospital Central Dr. Luis Ortega
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2014-03
Primary completion
2014-11
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 10 ug Other
Comparator Fentanyl Other / unclassified 25 ug Other
Comparator Bupivacaine Other / unclassified 12.5 mg Other

Indications

No indication recorded.