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

NCT ID: NCT02582372

Last Updated: 2015-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Dexmedetomidine in Subarachnoidal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine and bupivacaine

Intervention Type DRUG

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

fentanyl

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

Group Type ACTIVE_COMPARATOR

Fentanyl and bupivacaine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine and bupivacaine

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

Intervention Type DRUG

Fentanyl and bupivacaine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Central Dr. Luis Ortega

OTHER

Sponsor Role lead

Responsible Party

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Beatriz Arismendi Gómez

Clinical Professor Beatriz Arismendi Gomez

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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HCLuisOrtega

Identifier Type: -

Identifier Source: org_study_id

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