Comparison of the effectiveness of Dexmedtomidine and propofol during ERCP
Design
Clinical trial, with two intervention and control arms in parallel with random allocation and without blinding
Settings and conduct
The study population are ERCP candidate patients referred to Babol Educational and Medical Center who are randomly assigned to intervention and control groups after initial evaluations of the inclusion criteria. After the sedation intervention before the procedure, 5 minutes after the start, 15 minutes after the start of the procedure and after finishing the work with the Ramsay score tool is measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age18-65 years old؛ Absence of cardiovascular disease؛ ERCP candidate patients؛ Do not take sedatives؛ Absence of blood pressure؛ Absence of respiratory disease؛ Body Mass Index<30
Exclusion criteria: History of drug abuse؛ Medical allergy؛ Kidney disease؛ Liver disease Pregnancy
Intervention groups
Control group: Fentanyl at a dose of one microgram per kilogram of body weight up to a maximum of 100 micrograms with first receiving 1 mg per kilogram of body weight of propofol as STAT and then receiving a dose of 50 macro per kilogram per minute maintenance drug.
Intervention group: Fentanyl at a dose of one microgram per kilogram of body weight up to a maximum of 100 micrograms with a maintenance dose of dexmedetomidine at a dose of 1 microgram per kilogram of body weight per hour
Main outcome variables
Sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044907N4
Registration date:2021-08-27, 1400/06/05
Registration timing:registered_while_recruiting
Last update:2021-08-27, 1400/06/05
Update count:0
Registration date
2021-08-27, 1400/06/05
Registrant information
Name
seyed hossein hamidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 3301
Email address
a.hamidi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Dexmedtomidine and propofol during ERCP
Public title
The effectiveness of Dexmedtomidine and propofol during ERCP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age18-65 years old
Absence of cardiovascular disease
ERCP candidate patients
Do not take sedatives
Absence of blood pressure
Absence of respiratory disease
Body Mass Index<30
Exclusion criteria:
History of drug abuse
Medical allergy
Kidney disease
Liver disease
Pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of 40 using 4 blocks and 20 blocks with a ratio of 1: 1. In order to generate the allocation sequence, the free website www.randomization.com will be used. The notes will be written on separate sheets and will be placed in sealed envelopes and will be given to the principal investigator for study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2021-02-20, 1399/12/02
Ethics committee reference number
IR.MUBABOL.REC.1399.487
Health conditions studied
1
Description of health condition studied
Sedation
ICD-10 code
T88.52
ICD-10 code description
Failed moderate sedation during procedure
Primary outcomes
1
Description
Heart Rate
Timepoint
Before starting the procedure, 5 minutes after starting, 15 minutes after starting the procedure and after finishing the work.
Method of measurement
Number per minute
2
Description
O2 saturation
Timepoint
Before starting the procedure, 5 minutes after starting, 15 minutes after starting the procedure and after finishing the work.
Method of measurement
Pulse oximeter
3
Description
Sedation
Timepoint
Before starting the procedure, 5 minutes after starting, 15 minutes after starting the procedure and after finishing the work.
Method of measurement
Ramsay score
Secondary outcomes
empty
Intervention groups
1
Description
Control group: : Fentanyl at a dose of one microgram per kilogram of body weight up to a maximum of 100 micrograms with first receiving 1 mg per kilogram of body weight of propofol as STAT and then receiving a dose of 50 macro per kilogram per minute maintenance drug
Category
Treatment - Drugs
2
Description
Intervention group: Fentanyl at a dose of one microgram per kilogram of body weight up to a maximum of 100 micrograms with a maintenance dose of dexmedetomidine at a dose of 1 microgram per kilogram of body weight per hour