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| Name | Class |
|---|---|
| Universidad de La Frontera | OTHER |
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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
Alcohol withdrawal syndrome AWS (Alcohol Withdrawal Syndrome), is defined as the appearance of two or more data of autonomic hyperactivity, nausea, hallucinations and seizures associated with cessation of alcohol consumption. For its evaluation, the CIWA-Ar (Clinical Institute Withdrawal Assessment for Alcohol) scale is used, which guides the treatment based on benzodiazepines but a disadvantage is the related adverse effects, for which other pharmacological strategies of sedation have been tried, among them Dexmedetomidine (DEX).
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 (Alcohol Withdrawal Syndrome).
MATERIALS:
Prior authorization from the ethics committee of O'Horán Hospital, Yucatán, Mexico. No. Registration CEI-011-1-17, and signature of informed consent. A randomized clinical trial was carried out in the Adult Emergencies service during the period July 2017-July 2018. Forty participants with CIWA-Ar greater than 10 points participated. The administration of:
A) Diazepam 5-20 mg IV. B) DEX 0.2-0.7 mcg / Kg / min., until the CIWA-Ar scale decreases to <10.
The investigators are excluded minor patients, mild CIWA-Ar category, previous medication, participants with severe cranial encephalic trauma (TBI) or mechanical ventilation requirement, with chronic liver failure category C in the Child-Turcotte-Pugh classification.
RESULTS
The CIWA Ar scale average for admission was 23 points, the lowest of 10 points and the highest of 38 points. The average number of days consuming alcohol prior to hospital admission was 131.9, with the highest average in the group that used dexmedetomidine; the average number of days after having suspended the intake until hospital admission was 1.7 days, being slightly higher in the group that used diazepam; the shortest time was 6 hours and the longest of a week without being related to the CIWA Ar score.
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) After applying t student a significant difference was found in the number of days in favor of dexmedetomidine (p = 0.0016)
CONCLUSIONS
The investigators found that DEX at conventional doses, for the treatment of moderate-severe alcohol withdrawal in terms of reducing the CIWA-Ar scale, in fewer days and with fewer adverse effects and complications.
REFERENCES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Diazepam | Active Comparator | Dosage form: Diazepam 5-10 mg IV, steps until a maximum dose of 120 mg diazepam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| days of hospital stay | Duration in days of hospital stay | 24 hours limited to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nayely Garcia Mendez | Mexico City | 4780000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8701843 | Result | Yost DA. Alcohol withdrawal syndrome. Am Fam Physician. 1996 Aug;54(2):657-64, 669. | |
| 33423824 | Derived | 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. |
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| ID | Term |
|---|---|
| D000430 | Alcohol Withdrawal Delirium |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D020268 | Alcohol-Induced Disorders, Nervous System |
| D020258 | Neurotoxicity Syndromes |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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| Diazepam Injectable Solution | Drug | diazepam start with 5-20 mg IV as a dose response, steps until a maximum dose of 120 mg diazepam. |
|
| D064419 | Chemically-Induced Disorders |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D013375 | Substance Withdrawal Syndrome |
| D001523 | Mental Disorders |