Treatment Of Alcohol Withdrawal Syndrome: Dexmedetomidine Vs Diazepam In A Hospital O'horán
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03877120|
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|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.|
|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|
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.
- 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
- Average Diazepam Received (mg) [ Time Frame: Limited to 10 days ]Dosis total: Diacepam 5-20 mg IV
- 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
- heart rate average [ Time Frame: 24 hours ]mean values per 24 hours period for each patient
- Systolic blood pressure average [ Time Frame: 24hours ]mean values per 24 hours period for each patient
- days of hospital stay [ Time Frame: 24 hours limited to 10 days ]Duration in days of hospital stay
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
|Nayely Garcia Mendez|
|Ciudad de Mexico, Mexico, 4780000|