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

Phase 4

Completed

• Conditions: Dexmedetomidine in Subarachnoidal Anesthesia
• Interventions: Drug: Dexmedetomidine and bupivacaine; Drug: Fentanyl and bupivacaine

• Registration Number: NCT02582372
• Lead Sponsor: Hospital Central Dr. Luis Ortega

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-11
• Study Completion: 2015-02
• Status Verified: 2015-10
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-19
• Last Update Submitted: 2015-10-20
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Dexmedetomidine and bupivacaine	25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge
fentanyl	Fentanyl and bupivacaine	25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge

Primary Outcome Measures

Name	Time	Method
Changes of baseline oxygen saturation	during anesthesia and 1 hour of postoperatory
Changes of motor block using Bromage scale	during anesthesia and 1 hour of postoperatory
Changes of baseline blood pressure	during anesthesia and 1 hour of postoperatory
Postoperatory pain visual analogue scale	during first 24 hours of postoperatory
Changes of baseline cardiac rate	during anesthesia and 1 hour of postoperatory

Secondary Outcome Measures

Name	Time	Method
Numbers of patients with excessive sedation using Ramsay scale	during anesthesia and first 24 hours of postoperatory
Numbers of patients with nauseas	during anesthesia and first 24 hours of postoperatory
Numbers of patients with hypotension using non invasive blood presure monitor	during anesthesia and first 24 hours of postoperatory	we report hypotension below 20% of basal values