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

NCT02582372 | Completed Phase 4

• 1 other identifier: HCLuisOrtega
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dexmedetomidine in Subarachnoidal Anesthesia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Numbers of patients with hypotension using non invasive blood presure monitor

  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 Outcomes (1)

• Numbers of patients with signs of peripheral neurological toxicity using questionnaire

  during first seven days of postoperatory time

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

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

fentanyl

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine and bupivacaine DRUG

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

dexmedetomidine

Fentanyl and bupivacaine DRUG

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

fentanyl

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I and II
• lower abdominal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Central Dr. Luis Ortega: lead

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Beatriz Arismendi Gomez

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 21, 2015
• Study Start: March 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10