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

• Sponsor: Hospital Central Dr. Luis Ortega (Other)
• Overall Status: Completed
• CT.gov ID: NCT02582372
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 11.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dexmedetomidine in Subarachnoidal Anesthesia	Drug: Dexmedetomidine and bupivacaine; Drug: Fentanyl and bupivacaine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Subarachnoidal Anesthesia: Dexmedetomidine vs Fentanyl Plus Hyperbaric Bupivacaine for Lower Abdomen Surgery
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes of baseline blood pressure [during anesthesia and 1 hour of postoperatory]

2. Changes of baseline cardiac rate [during anesthesia and 1 hour of postoperatory]

3. Changes of baseline oxygen saturation [during anesthesia and 1 hour of postoperatory]

4. Postoperatory pain visual analogue scale [during first 24 hours of postoperatory]

5. Changes of motor block using Bromage scale [during anesthesia and 1 hour of postoperatory]

Secondary Outcome Measures

1. Numbers of patients with hypotension using non invasive blood presure monitor [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 [during anesthesia and first 24 hours of postoperatory]

3. Numbers of patients with nauseas [during anesthesia and first 24 hours of postoperatory]

Other Outcome Measures

1. Numbers of patients with signs of peripheral neurological toxicity using questionnaire [during first seven days of postoperatory time]

   phone contact

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Central Dr. Luis Ortega

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beatriz Arismendi Gómez, Clinical Professor Beatriz Arismendi Gomez, Hospital Central Dr. Luis Ortega
• ClinicalTrials.gov Identifier: NCT02582372
• Other Study ID Numbers: HCLuisOrtega
• First Posted: Oct 21, 2015
• Last Update Posted: Oct 22, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Fentanyl; Dexmedetomidine; Bupivacaine

Study Results

No Results Posted as of Oct 22, 2015