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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine in Subarachnoidal Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine and bupivacaine; Drug: Fentanyl and bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexmedetomidine; 25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 10 micrograms of dexmedetomidine, with needle 25 gauge	Drug: Dexmedetomidine and bupivacaine; 10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal
Active Comparator: fentanyl; 25 patients recieve subarachnoidal anesthesia with 12,5 mgrs of bupivacaine 0,5% plus 25 micrograms of fentanyl, with needle 25 gauge	Drug: Fentanyl and bupivacaine; 25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of patients with hypotension using non invasive blood presure monitor	we report hypotension below 20% of basal values	during anesthesia and first 24 hours of postoperatory
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of patients with signs of peripheral neurological toxicity using questionnaire	phone contact	during first seven days of postoperatory time

Collaborators and Investigators

• Sponsor: Hospital Central Dr. Luis Ortega

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: HCLuisOrtega