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

NCT02582372 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-10-22

No results posted yet for this study

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.

Conditions

  • Dexmedetomidine in Subarachnoidal Anesthesia

Interventions

DRUG

Dexmedetomidine and bupivacaine

10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal

DRUG

Fentanyl and bupivacaine

25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal

Sponsors & Collaborators

  • Hospital Central Dr. Luis Ortega

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-11-30
Completion
2015-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582372 on ClinicalTrials.gov