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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02582372
Acronym
Dex
Enrollment
50
Registered
2015-10-21
Start date
2014-03-31
Completion date
2015-02-28
Last updated
2015-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine in Subarachnoidal Anesthesia

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.

Interventions

DRUGDexmedetomidine and bupivacaine

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

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

Sponsors

Hospital Central Dr. Luis Ortega
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes of motor block using Bromage scaleduring anesthesia and 1 hour of postoperatory
Changes of baseline blood pressureduring anesthesia and 1 hour of postoperatory
Changes of baseline cardiac rateduring anesthesia and 1 hour of postoperatory
Changes of baseline oxygen saturationduring anesthesia and 1 hour of postoperatory
Postoperatory pain visual analogue scaleduring first 24 hours of postoperatory

Secondary

MeasureTime frameDescription
Numbers of patients with hypotension using non invasive blood presure monitorduring anesthesia and first 24 hours of postoperatorywe report hypotension below 20% of basal values
Numbers of patients with excessive sedation using Ramsay scaleduring anesthesia and first 24 hours of postoperatory
Numbers of patients with nauseasduring anesthesia and first 24 hours of postoperatory

Other

MeasureTime frameDescription
Numbers of patients with signs of peripheral neurological toxicity using questionnaireduring first seven days of postoperatory timephone contact

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026