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Treatment Of Alcohol Withdrawal Syndrome: Dexmedetomidine Vs Diazepam In A Hospital O'horán

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ClinicalTrials.gov Identifier: NCT03877120
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Universidad de la Frontera
Information provided by (Responsible Party):
GARCIA MENDEZ NAYELY, Centro Medico Nacional La Raza, IMSS

Brief Summary:

The cessation of alcohol consumption of people suffering from alcohol abuse frequently leads to the development of an alcohol withdrawal syndrome (AWS).

The ethylic suppression syndrome is defined as the appearance of two or more data of autonomic hyperactivity, nausea, hallucinations and seizures associated with the cessation of alcohol consumption. For its evaluation, the CIWA-Ar scale is used, which guides the treatment based on benzodiazepines but with many adverse effects, so sedatives have been tried, among them dexmedetomidine, an alpha-agonist with action in the locus caeruleus, with variable results. Objectives: The investigators aimed to compare the DEX vs. Diazepam, for moderate disease, applying the CIWA-Ar scale, in participants with severe to moderate AWS. Methodology: 40 participants with CIWA-Ar greater than 10 points, the investigators are collected and randomized into two groups: one under treatment with diazepam (Group Diazepam) and another with dexmedetomidine (Group Dexmedetomidine), until the CIWA-Ar was reduced to less than 10, and adverse effects the investigators also reported. The analysis was done with student t. Results: The average duration of treatment with diazepam was 5.5 days (IC 95 = 6.6-3.8), the average duration of treatment with dexmedetomidine was 3.1 days (95% CI = 4.5-1.7), with a significant difference ( p = 0.0016). In the group with diazepam 60% presented adverse effects and in the group with dexmedetomidine 25% presented them, with a significant difference (p = 0.04). Conclusion: dexmedetomidine was superior to diazepam for the treatment of moderate-severe alcohol withdrawal with fewer adverse effects.

KEY WORDS: Alcohol dependence · Alcohol withdrawal syndrome · Dexmedetomidine · Diazepam · Benzodiazepines


Condition or disease Intervention/treatment Phase
Alcohol Withdrawal Delirium Drug: Dexmedetomidine 0.004 MG/ML Drug: Diazepam Injectable Solution Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical Trials To compare Diazepam 5-20 mg IV or Dexmedetomidine 0.2-0.7 mcg / Kg / min., In monotherapy until the CIWA-Ar decreases to <10.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment Of Alcohol Withdrawal Syndrome: Dexmedetomidine Vs Diazepam In A Hospital O'horán
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Dexmedetomidine

Dexmedetomidine. Dexmedetomidine use 400 mcg in 100 cc 0.9% physiological solution in continuous infusion starting at a dose of 0.2 mcg / kg / hr titrating until reaching a decrease in the adrenergic response, with a maximum dose of 0.7 mcg / kg / hr7.

Dosage form: DEX 0.2-0.7 mcg/Kg/min.

Drug: Dexmedetomidine 0.004 MG/ML
Experimental studies and single case reports suggest the α2-agonist dexmedetomidine is effective in managing the autonomic symptoms seen with alcohol withdrawal.

Active Comparator: Diazepam
Dosage form: Diazepam 5-10 mg IV, steps until a maximum dose of 120 mg diazepam
Drug: Diazepam Injectable Solution
diazepam start with 5-20 mg IV as a dose response, steps until a maximum dose of 120 mg diazepam.




Primary Outcome Measures :
  1. Average Alcohol Withdrawal Scoring [ Time Frame: dosing, total dose per 24 hours period for each patient, limited to 10 days ]
    Total Score = 0 - 9: absent or minimal withdrawal 10 - 19: mild to moderate withdrawal more than 20: severe withdrawal

  2. Average Diazepam Received (mg) [ Time Frame: Limited to 10 days ]
    Dosis total: Diacepam 5-20 mg IV

  3. Average Dexmedetomidine Received (mg) [ Time Frame: dosing, total dose per 24 hours period for each patient, limited to 10 days ]
    Infusión: DEX 0.2-0.7 mcg/Kg/min

  4. heart rate average [ Time Frame: 24 hours ]
    mean values per 24 hours period for each patient

  5. Systolic blood pressure average [ Time Frame: 24hours ]
    mean values per 24 hours period for each patient


Secondary Outcome Measures :
  1. days of hospital stay [ Time Frame: 24 hours limited to 10 days ]
    Duration in days of hospital stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who received dexmedetomidine during their Emergency stay
  • Patients who received diazepam during their Emergency stay
  • CIE-10 codes consistent with alcohol withdrawal during hospitalization
  • CIWA-A score >10 points

Exclusion Criteria:

  • comorbid disease, including several with CNS trauma or cerebrovascular accidents, one with end-stage metastatic carcinoma, and one patient with severe sepsis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877120


Locations
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Mexico
Nayely Garcia Mendez
Ciudad de Mexico, Mexico, 4780000
Sponsors and Collaborators
Centro Medico Nacional La Raza, IMSS
Universidad de la Frontera

Publications of Results:
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Responsible Party: GARCIA MENDEZ NAYELY, Post doc Medical Sciences, Visiting professor, Universidad de la Frontera., Centro Medico Nacional La Raza, IMSS
ClinicalTrials.gov Identifier: NCT03877120     History of Changes
Other Study ID Numbers: CEI-011-1-17
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GARCIA MENDEZ NAYELY, Centro Medico Nacional La Raza, IMSS:
Dexmedetomidine
Diazepam
Alcohol dependence
Alcohol withdrawal syndrome
Benzodiacepines
Additional relevant MeSH terms:
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Delirium
Alcohol Withdrawal Delirium
Substance Withdrawal Syndrome
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol-Induced Disorders, Nervous System
Neurotoxicity Syndromes
Poisoning
Alcohol-Induced Disorders
Alcohol-Related Disorders
Ethanol
Diazepam
Dexmedetomidine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists