Comparison of the effects of propofol, ketamine, and ketofol on controlling agitation in children after herniorrhaphy
Design
A double-blind randomized clinical trial with parallel groups and phase 3 will be conducted on 105 patients. Patients will be assigned to one of three groups receiving propofol, ketamine, or ketofol. Randomization will be performed with the block randomization method using Random allocation software.
Settings and conduct
In this double-blinded clinical trial study, children undergoing herniorrhaphy at Urmia Shahid Motahari Hospital in will be enrolled. In the operating room, patients will be placed under routine monitoring such as electrocardiography, pulse oximetry, and non-invasive blood pressure monitoring. After inducing general anesthesia with sevoflurane, 105 patients will be randomly assigned to one of three groups: propofol 0.5 mg, ketamine 0.5 mg, and ketofol 0.5 mg. The study will be conducted as a double-blind clinical trial. The patient and the primary researcher who will assess the outcomes will be blind of the patient's allocation into one of the intervention groups.
Participants/Inclusion and exclusion criteria
In this study, 105 children aged 2 to 4 years undergoing herniorrhaphy under general anesthesia will be included. Children with mental retardation, neurological and pulmonary diseases will not be included in the study.
Intervention groups
In all patients after induction of general anesthesia with sevoflurane, for patients in group one Propofol 0.5 mg/kg, in group two Ketamine 0.5 mg/kg, and in group three Ketofol 0.5 mg/kg will be injected intravenously.
Main outcome variables
Agitation score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201207049639N9
Registration date:2023-06-12, 1402/03/22
Registration timing:prospective
Last update:2023-06-12, 1402/03/22
Update count:0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
Hadi Houshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
hooshyar.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of propofol, ketamine, and ketofol on controlling agitation in children after herniorrhaphy
Public title
Investigating the effect of propofol, ketamine and ketofol on agitation after herniorrhaphy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children undergoing herniorrhaphy under general anesthesia
Aged between 2-4 years
Patients with physical status classified as ASA II and ASA III according to the criteria of the American Anesthesia Association (ASA).
Exclusion criteria:
Mental retardation
Neurological diseases
Anomaly of the upper airway
History of asthma or other lung diseases
Pulmonary infections in the last 4 weeks
Age
From 2 years old to 4 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into interventions groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be selected. Patients will be allocated in intervention groups based on generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the primary researcher who will assess the outcomes will be blind of the patient's allocation into one of the intervention groups. The syringes containing drugs will be similar in shape and size and the drug will be prescribed by an anesthesiologist (other than the outcome assessor). Therefore, the physician will be given a list of numbers generated by computer software, and the physician will assign patients to groups based on the order of the numbers, and finally, the groups will be labeled with letters A, B, and C.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-03-08, 1401/12/17
Ethics committee reference number
IR.UMSU.REC.1401.422
Health conditions studied
1
Description of health condition studied
Agitation after surgery
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Agitation score
Timepoint
After extubation, the time to leave the operating room, recovery and 30 minutes after surgery.
Method of measurement
Four-point scale for assessing of agitation
Secondary outcomes
1
Description
Pain severity
Timepoint
Recovery, 30 minutes after surgery
Method of measurement
Consolability cry activity leg face (FLACC )
2
Description
Heart rate
Timepoint
Every 15 minutes to one hour, and at hours 6, 12, and 24 after surgery.
Method of measurement
Pulse oximetry
3
Description
Vomiting
Timepoint
Within 24 hours after surgery
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: For patients in group one, after induction of general anesthesia with sevoflurane, propofol 0.5 mg/kg will be injected intravenously.
Category
Treatment - Other
2
Description
Intervention group: For patients in group two after induction of general anesthesia with sevoflurane, Ketamine 0.5 mg/kg will be injected intravenously.
Category
Treatment - Other
3
Description
Intervention group: For patients in group three after induction of general anesthesia with sevoflurane, Ketofol 0.5 mg/kg will be injected intravenously.