Comparative study of the combination of dexmedetomidine-propofol, dexmedetomidine and propofol for sedation during mechanical ventilation in patients hospitalized in the intensive care unit
Comparative determination of the combination of dexmedetomidine-propofol, dexmedetomidine and propofol for sedation during mechanical ventilation in patients hospitalized in the intensive care unit
Design
Clinical trial, with parallel groups, three blinded, randomized, phase 3 on 90 patients, random allocation software was used for randomization
Settings and conduct
This study is a three-blind clinical and comparative study of patients who underwent mechanical ventilation and were admitted to the special care department of Al-Zahra (S) and Kashani Hospitals in Isfahan in 1402-1403. Patients who meet all the inclusion criteria were included in the study after obtaining informed consent. These patients are randomly divided into 3 groups
Participants/Inclusion and exclusion criteria
Study inclusion criteria: Age over 18 and under 70 Criteria for not entering the study: Patients with serious mental disorders and dementia Patients with contraindications to dexmedetomidine or propofol Patients with allergies to any of the drugs Patients who are unable to continue the research process for any reason. People with acute infectious diseases or severe underlying diseases
Intervention groups
An initial loading dose of dexmedetomidine or propofol was given to rapidly achieve stable plasma concentrations. In the first group, the loading dose of dexmedetomidine was 1 µg kg–1 h–1 within 10 minutes and then the infusion 0.1 µg kg–1h–1 and in the second group propofol (1%) loading dose 1 mg kg–1 within 10 minutes and then 1 mg kg–1 kg–1 h–1 infusion in the third group dexmedetomidine loading dose 0.5 µg kg–1 h-1 with the addition of propofol 0.5 mg kg-1 and then dexmedetomidine 0.05 µg kg-1h-1 with the addition of 0.5mg propofol kg-1kg-1h-1
Main outcome variables
Average dose of propofol consumed, average dose of dexmedetomidine consumed, average duration of mechanical respiration, blood pressure,heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N54
Registration date:2023-10-17, 1402/07/25
Registration timing:prospective
Last update:2023-10-17, 1402/07/25
Update count:0
Registration date
2023-10-17, 1402/07/25
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the combination of dexmedetomidine-propofol, dexmedetomidine and propofol for sedation during mechanical ventilation in patients hospitalized in the intensive care unit
Public title
study of the combination of dexmedetomidine-propofol, dexmedetomidine and propofol for sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years and under 70 mechanical ventilation hospitalized in the intensive care unit, Glasgow coma number is less than 9.
Exclusion criteria:
Patients with contraindications to dexmedetomidine and propofol
Patients with serious mental disorders and dementia
People with acute infectious diseases or severe underlying diseases including liver dysfunction, cardiovascular disorders including heart block, heart rate ≤ 60, heart failure with ejection fraction ≤ 30%, diabetes or severe blood pressure (120/180)
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way. The samples are randomly placed in three intervention groups 1, 2 and 3 by means of random allocation software. Sampling continues until the samples in all three groups reach the set limit
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a three-way blind clinical trial, so that the patient is included in the study but does not know the type of intervention applied and is blind, the person who records the patient's symptoms is also different from the person who injects the medicine. And without knowing the type of medicine, he only records the patient's symptoms during the study and therefore is kept blind. The analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Minimum ethics in the research of medical school of Isfahan University of Medical Sciences
Street address
Hear jerib
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-10-14, 1402/07/22
Ethics committee reference number
IR.MUI.MED.REC.1402.261
Health conditions studied
1
Description of health condition studied
Need for sedation during mechanical ventilation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation rate of patients
Timepoint
At the base time (before the start of the intervention) and then every 24 hours
Method of measurement
The level of patient sedation will be evaluated using the Ramsay criterion, whose validity and reliability have been confirmed by a recent study
Secondary outcomes
1
Description
Mean arterial pressure
Timepoint
Baseline time (before the start of the intervention) then every 6 hours
Method of measurement
barometer
2
Description
Heart Rate
Timepoint
Baseline time (before the start of the intervention) then every 6 hours
Method of measurement
ECG
3
Description
Arterial blood oxygen saturation
Timepoint
Baseline time (before the start of the intervention) then every 6 hours
Method of measurement
pulse oximeter
4
Description
blood pressure
Timepoint
Baseline time (before the start of the intervention) then every 6 hours
Method of measurement
Barometer
Intervention groups
1
Description
Intervention group: In the first group, the loading dose of dexmedetomidine was 1 µg kg–1 h–1 within 10 minutes and then the infusion 0.1 µg kg–1h–1
Category
Treatment - Drugs
2
Description
Intervention group: In the second group, propofol (1%) loading dose of 1 mg kg-1 within 10 minutes and then infusion of 1 mg kg-1 kg-1h-1
Category
Treatment - Drugs
3
Description
Intervention group: In the second group, propofol (1%) loading dose of 1 mg kg-1 within 10 minutes and then infusion of 1 mg kg-1 kg-1h-1
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad nazemoroaya
Street address
soffeh boulevard, shahid keshvari highway
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Behzad nazemoroaya
Street address
Ayatollah Kashani St
City
Esfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr mozhgan mortazavi
Street address
Hear jerib
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?