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Sponsor study identifier
interventional
2
1 country
1
Study Start
November 1, 2017
Actual (reported)Primary Completion
February 28, 2018
Actual (reported)Study Completion
August 31, 2018
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2017
Actual (reported)February 28, 2018
Actual (reported)August 31, 2018
Actual (reported)March 12, 2019
Actual (reported)March 15, 2019
Actual (reported)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
days of hospital stay
24 hours limited to 10 days
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.
Dosage form: Diazepam 5-10 mg IV, steps until a maximum dose of 120 mg diazepam
Experimental studies and single case reports suggest the α2-agonist dexmedetomidine is effective in managing the autonomic symptoms seen with alcohol withdrawal.
diazepam start with 5-20 mg IV as a dose response, steps until a maximum dose of 120 mg diazepam.
Nayely Garcia Mendez
Mexico City, 4780000, Mexico
Yost DA. Alcohol withdrawal syndrome. Am Fam Physician. 1996 Aug;54(2):657-64, 669.
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.
2 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2019
First Posted
March 15, 2019
Study Start
Contact the study team to confirm eligibility.
November 1, 2017
Primary Completion
February 28, 2018
Actual (reported)Study Completion
August 31, 2018
Actual (reported)Last Updated
March 15, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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