IV Dexmedetomidine in the Duration of Spinal Anesthesia With Hyperbaric Bupivacaine: Double Blind Randomized Trial.

• Status: Recruiting
• Trial end date: 2022-05-15
• Target enrollment: 0
• Participant gender: All

Summary

Introduction: Spinal anesthesia produces sensitive and motor block according to the administered local anesthetic. The total duration of surgical anesthesia depends on the dose, intrinsic properties of the anesthetic, and the use of additional drugs. Dexmedetomidine is an alpha-2 adrenergic agonist that has sedative and analgesic effects. The specific action site in the spinal cord receptors and in the locus coeruleus provide as well hypnotic and sympatholytic characteristics. The combination of spinal anesthesia and intravenous dexmedetomidine is a safe option for hemodynamically stable patients undergoing elective surgery. Material and methods: Double blind randomized trial. The objective is to time and compare the total duration of neuraxial blockade with spinal hyperbaric bupivacaine plus intravenous dexmedetomidine, against hyperbaric bupivacaine by itself. 60 patients shall be included, between the ages of 18 and 65 years, classified by the American Society of Anesthesiologists (ASA) I and II, undergoing lower limb elective orthopedic procedure, with spinal anesthesia plus epidural catheter. 50% of the patients (group A) will receive spinal hyperbaric bupivacaine and IV dexmedetomidine at 0.5 mcg/kg (real weight), and the other 50% (group B) will receive spinal hyperbaric bupivacaine plus IV 0.9% saline solution in equivalent volume.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• Previously accepted and signed informed consent.

• Age between 18 and 65 years

• Male or female

• ASA classified I or II

• Undergoing elective lower limb orthopedic surgery

• Neuraxial anesthesia with 10 mg of spinal bupivacaine (2ml at 0.5%)

• Inert epidural catheter

Exclusion Criteria

• Basal heart rate lower than 55 beats per minute

• Basal mean arterial pressure (MAP) lower than 65 mmHg

• Non-compensated heart disease

• Sinus bradycardia

• Drug allergy or intolerance

• Contraindication for neuraxial blockade

• Coagulopathy

• Lumbar structural pathology and/or vertebral instrumentation

• Local active infection at punction site

• Thrombocytopenia (lower than 80 K platelets)

• Non-controlled psychiatric disease

• Patients that receive drugs such as NSAIDs, acetaminophen and/or opioids within less than 3 hours prior to the procedure