Determination of the effect of propofol and ketofol on restlessness after anesthesia in children aged 18-6 months under cleft palate surgery
Design
A randomized, Triple-blinding clinical trial, with the parallel groups, Phase 2-3 on 86 patients
Settings and conduct
In this randomized three-blind randomized clinical trial study, 86 children who are candidates for cleft palate surgery presented at Imam Hossein Hospital in Isfahan will be included in the study and will be randomly divided into 2 groups. One group will receive propofol and the other group will receive ketofol. Delirium score, pain score, and hemodynamic parameters of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
The children aged 6 to 18 months, candidates for cleft palate surgery, classified as ASA I and II are included after obtaining the child's parent's satisfaction to participate in the study. Exclusion criteria include underlying diseases such as mitochondrial metabolism disorder and fat metabolism disorder, a history of convulsion, and growth retardation.
Intervention groups
All patients go to the operating room after premedication with 0.01 mg/kg midazolam and induction of anesthesia is performed by injecting 2 mg/kg propofol, 2 μg / kg fentanyl, and 0.5 mg/kg atracurium. Then, the patients of the first intervention group are anesthetized with 100 μg/kg/min of propofol with 50% oxygen and 50% air. The second intervention group is anesthetized with a combination of propofol at a dose of 75 μg/kg/min and ketamine at a dose of 25 μg/kg/min with 50% oxygen and 50% air.
Main outcome variables
Delirium; Pain; Pressure; Heart rate; Percentage of oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N22
Registration date:2021-01-20, 1399/11/01
Registration timing:registered_while_recruiting
Last update:2021-01-20, 1399/11/01
Update count:0
Registration date
2021-01-20, 1399/11/01
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of propofol and ketofol on restlessness after anesthesia in children aged 18-6 months under cleft palate surgery
Public title
The effect of propofol and ketofol on restlessness after anesthesia in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 6 to18 months
Candidate for cleft palate surgery
Classified as ASA I and II based on American Society of Anesthesiologists Classification
Consent to participate in the study
Exclusion criteria:
Underlying diseases such as mitochondrial metabolic disorders and fat metabolism disorders
History of convulsion
Growth and development retardation
Age
From 6 months old to 18 months old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 86 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, propofol and ketofol, are prepared by the pharmacist and placed in coded packages, and delivered daily to an anesthesiologist, who prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.MUI.MED.REC.1399.765
Health conditions studied
1
Description of health condition studied
Cleft palate
ICD-10 code
Q35.9
ICD-10 code description
Cleft palate, unspecified
Primary outcomes
1
Description
Delirium score
Timepoint
Immediately upon entering the recovery ward and 15, 30 and 45 minutes later in the recovery
Behavioral scale derived from the Face, Leg, Activity, Cry, Consolability (FLACC)
3
Description
Blood Pressure
Timepoint
Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery
Method of measurement
Monitoring device
4
Description
Heart rate
Timepoint
Immediately after surgery, in the minutes of 15, 30, and 45 during surgery and immediately, 15, 30, and 45 minutes after recovery
Method of measurement
Monitoring device
5
Description
Percentage of oxygen saturation
Timepoint
Immediately after surgery, in the minutes of 15, 30 and 45 during surgery and immediately, 15, 30 and 45 minutes after recovery
Method of measurement
Monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Anesthesia induction is performed for patients by injecting 2 mg/kg propofol(Caspian Tamin Pharmaceutical), 2 μg/kg fentanyl(Caspian Tamin Pharmaceutical), and 0.5 mg/kg atracurium(Caspian Tamin Pharmaceutical). The propofol (Caspian Tamin Pharmaceutical) maintenance anesthesia is administered to the patient at 100 μg/kg/min with 50% oxygen.
Category
Treatment - Drugs
2
Description
Second intervention group: Anesthesia induction is performed for patients by injecting 2 mg/kg propofol(Caspian tamin Pharmaceutical), 2 μg/kg fentanyl(Caspian Tamin Pharmaceutical), and 0.5 mg/kg atracurium(Caspian Tamin Pharmaceutical). The maintenance anesthesia including a combination of propofol (Caspian Tamin Pharmaceutical) at a dose of 75 μg/kg/min and ketamine (Rotex Medica Pharmaceutical) at a dose of 25 μg/kg/min with 50% oxygen, is administered to the patient.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Isfahan
Full name of responsible person
Amir Shafa
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.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
Amir Shafa
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
shafa_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
shafa_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Ghorbani
Position
Non-faculty physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
fatemeghorbani2014@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD