Comparison of the sedation effect of Dexmedetomidine and midazolam using the Richmond agitation sedation scale (RASS) in patients admitted to clinical toxicology intensive care unit
According to high prevalence of poisoning in Isfahan and the necessity of maintaining of airway by intubation which needs sedation before doing this procedure , And also both of Midazolam and Dexmedetomidine are safe and effective drugs for the sedation before intubation, we decided to compare the rate of sedation inducing by these drugs.
Design
This clinical trial has control group, with two parallel group, blinded and Random Allocation with two groups each including 30 people. for random allocation we use Random Allocation software.
Settings and conduct
In this study two people would be blinded, first the person who would fill the RASS scale forms, second the person who analyses the data.
After random allocation into two groups each including 30 patients that admitted to ICU of poisoning patients in Khorshid hospital, we will give one group Dexmedetomidine and other group, Midazolam. then we measure the rate of sedation before and after taking drugs and intubation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with ASA class of III,IV admitted to ICU
2- Age between 18 to 80
3- Patients who are undergoing sedation before intubation
4- Not taking sedative drugs before admitting to ICU
Non entry criteria:
1- Serum Creatinine more than 200 microMol/Lit
2- Allergy to any of the drugs used in this study
3- Patients with unstable angina or acute myocardial infarction
4- Advanced liver failure
Intervention groups
There would be two intervention group in this clinical trial that one of them would be taking Dexmedetomidine before intubation and the other group would be taking Midazolam. Then we use RASS scale to score the level of sedation that induced in patients.
Main outcome variables
1- Assessment and compare rate of sedation induced by each drugs by Richmond agitation-sedation scale (RASS)
2- Blood pressure measurement
3- Heart rate measurement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211022052838N1
Registration date:2023-06-21, 1402/03/31
Registration timing:prospective
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Arman Otroshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 4261
Email address
arman.otroshi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the sedation effect of Dexmedetomidine and midazolam using the Richmond agitation sedation scale (RASS) in patients admitted to clinical toxicology intensive care unit
Public title
Comparison between sedating effect of Midazolam and Dexmedetomidine in intubated poisoned patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with American society of anesthesiologist (ASA) class 3 and 4 who are admitted in ICU of poisoned patients
Age between 18 to 80
Patients whom are going to be intubated
Not taking sedative drugs before admitting to intensive care unit (ICU)
Exclusion criteria:
known allergy to any of the drugs used in this study
advanced liver disease
Serum creatinine level above 200 micromol/liter
Unstable angina or acute myocardial infarction patients
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation of eligible people into two groups is done by Random allocation software.
There are several boxes in this software: the number of groups, the total number of samples. After specifying the number of groups (2) and the total number of samples (60), the software randomly divides the entire sample into two groups of 30.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the randomization done by the software, the main author of the plan (professor) knows which patient will take which of the drug categories and injects the ampoule containing the sedative drug to the patient, while the patient does not know which of the two drugs, has received. Then the outcome assessor (student) comes to the patient's bedside and fills the RASS form without knowing what medicine the patient has taken. Then the information and forms are provided to the data analyst without knowing which medicine the patient has received, and after the analysis, he provides the information to the main author of the plan.
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, isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-04-04, 1402/01/15
Ethics committee reference number
IR.MUI.MED.REC.1402.024
Health conditions studied
1
Description of health condition studied
Sedation before Intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of sedation caused by drug according to RASS scale
Timepoint
Before intervention and then every 2 hours
Method of measurement
RASS scale system is a known scale in the world that measured the rate of sedation whom admitted to ICU. Scoring points in this scale include -5 to +4 that the +4 point belongs to agitated and aggressive patients who are a threat for ICU personals. the -5 points belongs to the patients who are not responding to voice and physical stimulations and they are not conscious. the rest of points are spectrum between these two scores.
2
Description
Blood pressure in the admitted patients of ICU
Timepoint
Before intervention and then every 2 hours
Method of measurement
Vital sign monitoring device
3
Description
Heart rate
Timepoint
Before intervention and then every 2 hours
Method of measurement
Vital sign monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients admitted to Intensive care unit (ICU) of poisoned patients
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Arman Otroshi
Street address
Khorshid medical educational research complex, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
nobakht9877@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arman Otroshi
Street address
Isfahan university of medical sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
nobakht9877@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?