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

NCT05335655 | Unknown Phase 3

• 1 other identifier: 24-CEI-001-20160427
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Total time of spinal anesthesia with hyperbaric bupivacaine

  Time (minutes) from anesthetic onset, until first sign (sensitive/motor) of blockade regression.

  Up to 300 minutes

• Presence of post-operative pain

  Patient refers pain (Yes or No)

  Up to 120 minutes

Secondary Outcomes (1)

• Adverse effects Adverse Effects

  Through anesthetic period while administering IV drug

Study Arms (2)

Group A

ACTIVE COMPARATOR

IV bolus of dexmedetomidine, blindly administered and tittered to 0.5mcg per kilogram (real weight), diluted in 10 ml of 0.9% saline solution during 15 minutes before the spinal block. Once the anesthetic effect is confirmed, the maintenance IV infusion, based on dexmedetomidine 100 mcg diluted in 100 ml of 0.9% saline solution tittered at 0.5 mcg per kilogram per hour (real weight), begins.

Drug: Dexmedetomidine injection

Group B

PLACEBO COMPARATOR

IV 10 ml initial bolus of 0.9% saline solution during the 15 minutes before the spinal block. Once de anesthetic effect is confirmed, the maintenance infusion of IV 0.9% saline solution (100 ml in equivalent dosage per hour) begins.

Drug: Sodium Chloride 0.9% infusion

Interventions

Dexmedetomidine injection DRUG

IV initial bolus and trans operative dexmedetomidine infusion.

Also known as: Precedex infusion

Group A

Sodium Chloride 0.9% infusion DRUG

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

Also known as: Placebo

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Central "Dr. Ignacio Morones Prieto": lead

Study Sites (1)

Hospital Central Dr Ignacio Morones Prieto

San Luis Potosí City, 78210, Mexico

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Juan Francisco Hernández Sierra, M in C

  Universidad Autonoma de San Luis Potosí

  STUDY DIRECTOR

Central Study Contacts

Liliana Serrano Ibarrola, MD

CONTACT

+52 3313270064; ibarrola_92@hotmail.com

Juan Francisco Hernández Sierra, M in C

CONTACT

+52 4443082889; kiko_hdzs@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Each patient is assigned to one of the two treatment groups (A of B) according to a computer-generated chart of random numbers. Under standard preanesthetic procedures (non-invasive monitoring, premedication), we blindly administer an IV bolus of dexmedetomidine tittered to 0.5mcg per kilogram (real weight), diluted in 10 ml of 0.9% saline solution during 15 minutes before the spinal block. Once the anesthetic effect is confirmed, we begin a maintenance IV infusion for group A, based on dexmedetomidine 100 mcg diluted in 100 ml of 0.9% saline solution tittered at 0.5 mcg per kilogram per hour (real weight). On the other hand, for group B, we administer the same volume (10 ml) of IV 0.9% saline solution for the initial bolus, and for the maintenance infusion we keep equivalent organoleptic characteristics of simple intravenous 0.9% saline solution as well.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 19, 2022
• Study Start: January 31, 2022
• Primary Completion: June 10, 2022
• Study Completion: June 15, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)