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

NCT03877120 | Completed Phase 4 DMC

• 1 other identifier: CEI-011-1-17
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Alcohol Withdrawal Delirium

Keywords

Dexmedetomidine; Diazepam; Alcohol dependence; Alcohol withdrawal syndrome; Benzodiacepines

Outcome Measures

Primary Outcomes (5)

• Average Alcohol Withdrawal Scoring

  Total Score = 0 - 9: absent or minimal withdrawal 10 - 19: mild to moderate withdrawal more than 20: severe withdrawal

  dosing, total dose per 24 hours period for each patient, limited to 10 days

• Average Diazepam Received (mg)

  Dosis total: Diacepam 5-20 mg IV

  Limited to 10 days

• Average Dexmedetomidine Received (mg)

  Infusión: DEX 0.2-0.7 mcg/Kg/min

  dosing, total dose per 24 hours period for each patient, limited to 10 days

• heart rate average

  mean values per 24 hours period for each patient

  24 hours

• Systolic blood pressure average

  mean values per 24 hours period for each patient

  24hours

Secondary Outcomes (1)

• days of hospital stay

  24 hours limited to 10 days

Study Arms (2)

Dexmedetomidine

SHAM COMPARATOR

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

Diazepam

ACTIVE COMPARATOR

Dosage form: Diazepam 5-10 mg IV, steps until a maximum dose of 120 mg diazepam

Drug: Diazepam Injectable Solution

Interventions

Dexmedetomidine 0.004 MG/ML DRUG

Experimental studies and single case reports suggest the α2-agonist dexmedetomidine is effective in managing the autonomic symptoms seen with alcohol withdrawal.

Dexmedetomidine

Diazepam Injectable Solution DRUG

diazepam start with 5-20 mg IV as a dose response, steps until a maximum dose of 120 mg diazepam.

Diazepam

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centro Medico Nacional La Raza, IMSS: lead
• Universidad de La Frontera: collaborator

Study Sites (1)

Nayely Garcia Mendez

Mexico City, 4780000, Mexico

Location

Related Publications (2)

• Yost DA. Alcohol withdrawal syndrome. Am Fam Physician. 1996 Aug;54(2):657-64, 669.

  PMID: 8701843 RESULT

• Garcia-Mendez N, Briceno-Santana M, Totomoch-Serra A, Manterola C, Otzen T, Valdez PS, Campos-Duran R, Reyna GC. The hemodynamic effects of diazepam versus dexmedetomidine in the treatment of alcohol withdrawal syndrome: A randomized clinical trial. Med Clin (Barc). 2021 Dec 24;157(12):561-568. doi: 10.1016/j.medcli.2020.09.023. Epub 2021 Jan 8. English, Spanish.

  PMID: 33423824 DERIVED

MeSH Terms

Conditions

Alcohol Withdrawal Delirium; Alcoholism

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Alcohol-Induced Disorders, Nervous System; Neurotoxicity Syndromes; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doc Medical Sciences, Visiting professor, Universidad de la Frontera.

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: November 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: August 31, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

ME (1)