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临床试验/CTRI/2024/07/070438
CTRI/2024/07/070438已完成4 期

Comparative study of Intramuscular Midazolam, Lorazepam and Haloperidol-Promethazine combination for management of acute agitation.

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年7月22日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
Time till adequate sedation using Altered Mental Status Scale (AMSS)

研究概览

简要总结

In the event that the patient meets the study’s eligibility requirements, socio-demographic and  clinical profile and the baseline AMSS score will be gathered. CAM would be applied to filter  out patients with delirium. Computer generated number will be used for randomization. Each patient would either receive 5mg midazolam or 2mg lorazepam or 5mg haloperidol and 50 mg promethazine combination.  Time to adequate sedation (defined as AMSS score less than/equal to 0) will be recorded with a stopwatch.  Occurrence of bradycardia (Pulse Rate <60 beats per minute), extrapyramidal adverse effects  (akathisia or dystonia), allergic reactions (rash, wheezing, or anaphylaxis), hypoxemia (oxygen  saturation <93%), or intubation will also be noted.Patient would be followed up till 12 hours after the intramuscular injection has been given.  AMSS score would be calculated at 0, 30 min, 1 hour, 6 hour and 12 hour mark. Blood pressure,  pulse rate, oxygen saturation and AIMS score (for extrapyramidal symptoms) would also be  noted. In case the patient continues to have disruptive behavior at 30 minutes after first dose, repeat dose of same agent, that is, 5mg midazolam or 2mg lorazepam or 5mg haloperidol and 50 mg  promethazine combination, will be considered and documented. If the patient remains  disruptive at 1 hour mark or after 2 injections, it will be considered as “failure to sedate”,  however management will continue as standard care. If repeat dose of sedative is given up till 12 hours after adequate sedation is once achieved, it  will be documented. Comparison between 3 subgroups regarding time of adequate sedation and need for repeat  sedation will be done. After the end of study period, that is 12 hours, treatment as usual will resume.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Altered Mental Status Scale (AMSS) score greater than 1.

排除标准

  • Patient with known allergy of either midazolam or lorazepam or haloperidol or promethazine.
  • Patient with medically reversible cause of agitation (hypotension, hypoxia or hypoglycemia).
  • Patient known to be pregnant or lactating.
  • Patient presenting with drug withdrawals or drug intoxication within past 48 hours.
  • Patient with history of head injury within past 48 hours.
  • Patient in active Delirium.
  • Patient chemically restrained in past 24 hours.

结局指标

主要结局

Time till adequate sedation using Altered Mental Status Scale (AMSS)

时间窗: 0 min, then every 3 minutes till adequate sedation

次要结局

  • Need for repeat sedation(0,30 min, 1 hour, 6 hour, 12 hour)

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Lakhwinder Singh

Government Medical College and Hospital, Sector 32, Chandigarh

研究点 (1)

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