Comparison of the effect of adding low doses of Ketamine to Dxmedetomidine and Propofol on the sedative quality and hemodynamic response in Children during Upper Gastrointestinal Endoscopy
Determining the effect of adding ketamine to dexmedetomedine and propofol on the quality of sedation and hemodynamic response in pediatric endoscopy
Design
Two arm clinical trial with parallel, double-blind, randomized groups using a random number table, phase three groups on 52 patients.
Settings and conduct
The patient and the data collector were unaware of the drug and drug groups used.
Three syringes (dexmedetomidine 4 milliliter per Mililiter, propofol 4 milligram per milliliter , ketamine 1 milligram per milliliter) will be prepared and injected. Patients are evaluated and recorded every five minutes based on Ramsey criteria and variables.
Participants/Inclusion and exclusion criteria
1- Patients 2 to 12 years old
2- Consent of the patient or parents to participate in the study
;
1- ventricular atrial block (Grade 2 or 3 ) in electrocardiography
2- Slow heart rate
3- QTc more than 550 Millisecond in electrocardiography
4- Severe heart failure
5- low blood pressure (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mm Hg)
6- Liver disease
7- Using any analgesic drug
8- History of chronic pain syndromes,
9- history of any allergy to the drug used in the design
Intervention groups
Patients in the first group (group D) will receive dexmedetomidine and patients in the second group (group M) will receive propofol for sedation during surgery. The sample size in each group was 26 people
Main outcome variables
Depth of relaxation; ; blood pressure ; Heart rate; Recovery time; Duration of anesthesia; Intraoperative complications; Desaturation cases; Complications in recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N21
Registration date:2022-06-01, 1401/03/11
Registration timing:registered_while_recruiting
Last update:2022-06-01, 1401/03/11
Update count:0
Registration date
2022-06-01, 1401/03/11
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding low doses of Ketamine to Dxmedetomidine and Propofol on the sedative quality and hemodynamic response in Children during Upper Gastrointestinal Endoscopy
Public title
The effect of adding Ketamine to Dxmedetomidine and Propofol on the sedative quality and hemodynamic response in Children during Upper Gastrointestinal Endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of the patient or parents to participate in the study
Patients aged 2 to 12 years
Exclusion criteria:
ventricular atrial block (Grade 2 or 3 ) in electrocardiography
Slow heart rate
QTc more than 550 Millisecondon electrocardiography
Severe heart failure
low blood pressure (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg)
Liver disease
Use of any analgesic drug (due to possible drug interactions with the two drugs used in the study and the possibility of influencing the conclusion and prejudice of anesthesia)
History of any allergy to the drug used in the design (dexmedetomidine and propofol)
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random sequence generated from random allocation software, patients were enrolled individually in the two groups receiving ketamine-dexmedetomidine (DK) and ketamine-propofol (KP) were included in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blinded.Patient and researcher are unaware of patient groups and type of medication.The medications are prepared by an anesthetist who is unaware of the grouping of patients and is worn by an aluminum foil and encoded by an anesthetist.Demographic information; Sedation level. The quality of pain relief and hemodynamic variables and complications are collected by a patient who is not aware of the type of drug and patient grouping
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 Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-12-11, 1400/09/20
Ethics committee reference number
IR.MUI.MED.REC.1400.683
Health conditions studied
1
Description of health condition studied
Anesthesia for endoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation depth
Timepoint
Every 5 minutes during procedure and every 10 minutes in recovery
Method of measurement
Ramsey Sedation criteria
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes
Method of measurement
Blood pressure barometer
2
Description
Heart rate
Timepoint
Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes
Method of measurement
Pulse oximeter
3
Description
Recovery time
Timepoint
After completing the intervention until the withdrawal from the recovery
Method of measurement
Minute Numbers
4
Description
Surgery time
Timepoint
From the beginning of the surgery
Method of measurement
Minute Numbers
5
Description
Duration of anesthesia
Timepoint
From the time of anesthesia injection to the time of consciousness
Method of measurement
Minute Numbers
6
Description
Complications (bradycardia, apnea)
Timepoint
Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes
Method of measurement
Monitoring
7
Description
Incidence of complications in recovery
Timepoint
Every 10 minutes after the end of the intervention for 30 minutes
Method of measurement
Patient monitoring and observation
Intervention groups
1
Description
Intervention group: In dexmedetomidine group (Dk), patients will receive 1-0. 7 micrograms per kilogram of dexmedetomidine and then bolus ketamine 0.4 mg per kilogram in 50 ml of normal saline for 10 minutes followed by infusion of dexmedetomidine at 50 micrograms per kilogram per hour and ketamine 0.4 micrograms per kilogram per hour.
Category
Treatment - Drugs
2
Description
Intervention group: In Propofol group (kp), patients will receive 100-50 micrograms per kilogram of Propofol and then bolus ketamine 0.4 mg per kilogram in 30 ml of normal saline for 10 minutes followed by infusion of Propofol at 50 micrograms per kilogram per hour and ketamine 0.4 micrograms per kilogram per hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Children's Educational and Medical Center
Full name of responsible person
Hamidreza Shetabi
Street address
Imam Hossein Children's Educational and Medical Center - Imam Khomeini St. - before Esteghlal Square - Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Fax
Email
emamhossein_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
شقایق حق جوی جوانمرد
Street address
Vice chancellor of research and technology of university, Isfahan University of Medical Sciences, Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz hospital, Modarres st
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feiz Hospital, Modarres st.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Hamidshetabi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Unidentifiable individual data of participants including hemodynamic indicators and complications can be shared in all two groups.
When the data will become available and for how long
6 month after publication of paper
To whom data/document is available
Academic and medical researcher
Under which criteria data/document could be used
Use for research and treatment purpose
From where data/document is obtainable
Email of person in charge of public accountability ,Dr Hamidreza Shetabi: hamidshetabi@med.mui.ac.ir
What processes are involved for a request to access data/document
After the request, it will be sent by email, if possible, within a maximum of one month.