This study aimed to investigate the efficacy of olanzapine and haloperidol in the treatment of delirium in patients with ICU intoxication.
Design
36 patients with delirium are divided into two groups of 18 each. Each drug is randomly assigned double-blind and randomized to each group using blocking.
Settings and conduct
Patients with intoxication in the ICU of Loghman Hospital in Tehran, for whom delirium is diagnosed. The placement of patients in each intervention group is based on a randomized blocking method. For each treatment method, we created 6 blocks, and then we created random numbers through the computer, and then we sorted the blocks on them, and then we randomly assign each of them to each group. It is an individual randomization unit. Hiding is also done by using encrypted envelopes. The drugs are encrypted in envelopes and given by the nurse, and the information is collected by the poisoning fellowship.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients over 18 years of age with acute intoxication admitted to the ICU and without dementia.
Exclusion criteria:
1. Those who take antipsychotic drugs for any reason
Patients are using alcohol or benzodiazepine
3. Patients who were allergic to haloperidol or olanzapine,
4. The patient has severe agitation.
Intervention groups
Patients with delirium, one group receiving olanzapine 5 mg 3 times a day, and the other group receiving haloperidol 3 mg 3 times a day for up to 5 days, depending on the response to treatment.
Main outcome variables
The outcome of the study is a change in the symptom of delirium on the basis of the MDAS score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044909N1
Registration date:2020-07-21, 1399/04/31
Registration timing:retrospective
Last update:2020-07-21, 1399/04/31
Update count:0
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Javad Mesbahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5000
Email address
j.mesbahi1969@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of haloperidol and olanzapine in the treatment of delirium patient admitted in ICU
Public title
Effect of olanzapine in delirium of poisoning patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria included patients over 18 years of age who had acute intoxication without dementia
Exclusion criteria:
Patients who take antipsychotic drugs for any reason
Patients are using alcohol or benzodiazepine
Patients who were allergic to haloperidol or olanzapine,
Patients who have severe agitation
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
We randomly generated 6 blocks for the study intervention and then generated random numbers from the computer and then arranged the blocks on them and then randomly assigned each group to each individual randomization unit. . Hiding is also done by using randomly formatted encrypted boxes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medication is given to the nurse in anonymous envelopes by the nurse and noted in the questionnaire form.The patient does not know the type of medication
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research
Street address
Loghman Hospital,Makhsos Ave
City
Tehran
Province
Tehran
Postal code
1333631151
Approval date
2019-11-25, 1398/09/04
Ethics committee reference number
ir.sbmu.retech.rec.1398.426
Health conditions studied
1
Description of health condition studied
delirium patient admitted in ICU
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in the symptoms of delirium: All symptoms related to decreased attention and memory impairment are eliminated. Response to treatment is based on changes in MDAS scores.impairment are resolved. The response to treatment is based on improvement in the MDAS score.
Timepoint
Treatment results are evaluated by the researcher on days 3 and 5.
Method of measurement
Delirio intensity is measured on the MDAS score, which includes 10 items and 4 points.This intensity will be rated in MDAS <= 15 as "mild", in 16 <= MDAS <= 22 as "moderate" and in 23 <= MDAS <= 30, it will be rated "severe". The remission index for this disease based on this score is MDAS values less than 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: olanzapine pill 5 mg, made by Marham Daroo Company and is prescribed orally every 8 hours to three days
Category
Treatment - Drugs
2
Description
Control group: Halopiridolis pill 5 mg, made by Iran Daroo Company and is prescribed orally every 8 hours to three days.