Evaluation and comparison of the effect of haloperidol and quetiapine in the prevention of delirium in patients with end-stage cancer candidates receiving palliative care at home
Determination and comparison of frequency distribution (relative frequency) of delirium incidence in three groups receiving haloperidol, quetiapine and control group
Design
This study uses a double-blind randomized clinical trial with a control group and parallel randomized groups, which examines and compares the effect of haloperidol and quetiapine (manufactured by Iranian companies) in the prevention of delirium in end-stage cancer patients. Excel random rendering software is used for randomization
Settings and conduct
The study sample is selected from patients of Omid Hospital and Isfahan Branch of Ala Cancer Prevention and Control Center (MAXA) in 1399. Individuals are divided into 3 groups by random block method. In this way, the first 3 qualified people are selected and after obtaining consent, they enter to participate in the study. These 3 people are considered as a triple block and are arranged according to the last digit of the national code. Prevention methods are identified as A, B and C, and all three compounds are identified, and after the last administration of drugs for the last block, we decode.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of any type of end-stage cancer in the patient by an oncologist (discontinuation of treatment with a prognosis of less than 6 months)
Conscious consent of the patient or his family to participate in the study
Exclusion criteria:
Existence of major neurocagnetic disorder
Existence of delirium disorder according to DSM-V criteria by a psychiatric assistant and obtaining a score less than 5 in the ICDSC questionnaire
Any contraindications to the use of antipsychotic drugs
Intervention groups
Group A: Haloperidol receptor (1 mg daily / divided into 2 doses)
Group B: Quetiapine receptor (25 mg daily / divided into 2 doses)
Main outcome variables
Delirium prevention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201205049612N1
Registration date:2021-01-16, 1399/10/27
Registration timing:registered_while_recruiting
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Mehrsa Kebari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3435 3008
Email address
mehrshad_m19@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of haloperidol and quetiapine in the prevention of delirium in patients with end-stage cancer candidates receiving palliative care at home
Public title
Comparison of the effect of haloperidol and quetiapine in the prevention of delirium in patients with end-stage cancer candidates receiving palliative care at home
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of any type of end-stage cancer in the patient by the oncologist (discontinuation of therapeutic treatment with a prognosis of less than 6 months)
Conscious consent of the patient or his family to participate in the study
Exclusion criteria:
Existence of major neurocagnetic disorder
Existence of delirium disorder according to DSM-V criteria by a psychiatric assistant and obtaining a score less than 5 in the ICDSC questionnaire
Any contraindications to the use of antipsychotic drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are divided into 3 groups by random block method. In this way, the first 3 qualified people are selected and after obtaining consent, they enter to participate in the study. These 3 people are considered as a triple block and are arranged according to the last digit of the national code. Prevention methods are specified as A, B and C, and we identify all three compounds, and after the last prescription of drugs for the last block, we decrypt.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the randomized block method, individuals are divided into three groups and then the drug is prepared by an individual and specified with a code and given to the researcher (student). The researcher starts the medication and evaluates the patients on a weekly basis using a questionnaire and records the results based on the patient code. Patients are also unaware of the type of medication they are receiving.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate