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

NCT05335655 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-06-13

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Dexmedetomidine

Interventions

DRUG

Dexmedetomidine injection

IV initial bolus and trans operative dexmedetomidine infusion.

DRUG

Sodium Chloride 0.9% infusion

IV initial bolus and trans operative infusion of 0.9% saline solution.

Sponsors & Collaborators

  • Hospital Central "Dr. Ignacio Morones Prieto"

    lead OTHER

Principal Investigators

  • Juan Francisco Hernández Sierra, M in C · Universidad Autónoma de San Luis Potosí

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-06-10
Completion
2022-06-15

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335655 on ClinicalTrials.gov