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OpenTrials
Completed

NCT Number: NCT02582372

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

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.

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Key information

Conditions

Dexmedetomidine in Subarachnoidal Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine and bupivacaine

Drug

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

Fentanyl and Bupivacaine

Drug

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

Primary outcomes

  1. Changes of baseline blood pressure

    Time frame: during anesthesia and 1 hour of postoperatory

  2. Changes of baseline cardiac rate

    Time frame: during anesthesia and 1 hour of postoperatory

  3. Changes of baseline oxygen saturation

    Time frame: during anesthesia and 1 hour of postoperatory

  4. Postoperatory pain visual analogue scale

    Time frame: during first 24 hours of postoperatory

  5. Changes of motor block using Bromage scale

    Time frame: during anesthesia and 1 hour of postoperatory

Secondary outcomes

  1. Numbers of patients with hypotension using non invasive blood presure monitor

    Time frame: during anesthesia and first 24 hours of postoperatory

    we report hypotension below 20% of basal values

  2. Numbers of patients with excessive sedation using Ramsay scale

    Time frame: during anesthesia and first 24 hours of postoperatory

  3. Numbers of patients with nauseas

    Time frame: during anesthesia and first 24 hours of postoperatory

Other outcomes

  1. Numbers of patients with signs of peripheral neurological toxicity using questionnaire

    Time frame: during first seven days of postoperatory time

    phone contact

Sponsors and collaborators

Lead sponsor

Hospital Central Dr. Luis Ortega

Other

Registry information

Acronym: Dex

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Oct 21, 2015
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.