Efficacy of nebulized Dexmedetomidine-ketamine and midazolam-ketamine in preoperative sedation for pediatric ophthalmic surgery
Design
A clinical trial with a control group, double-blind, randomized, phase 3 on 60 patients was used for randomization using the rand function of Excel software.
Settings and conduct
double-blind, prospective clinical randomized controlled trial study was conducted in Farabi Hospital, Tehran, Iran, on 60 patients. The patients are divided into two groups of 30 people. An independent researcher who is not involved in the study opens the envelopes one hour before the start of anesthesia, and the drugs are prepared in identical syringes with matching random codes. Informed consent will be obtained from parents or authorized guardians. Participants in the intervention group will receive nebulized dexmedetomidine (2 μg/kg) with ketamine (1 mg/kg) and the control group will receive nebulized midazolam (0.1 mg/kg) with ketamine (1 mg/kg). The study drugs are administered through a conventional nebulizer with a mouthpiece with oxygen at a rate of 6 L/min, 30 minutes before surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA I and II؛ Children aged 3-7 years؛ Elective eye surgery under general anesthesia
Exclusion criteria: Renal or hepatic dysfunction؛ allergy to midazolam؛ asthma؛ neurologic disease
Intervention groups
nebulized Dexmedetomidine-ketamine and midazolam-ketamine
Comparison efficacy of nebulized Dexmedetomidine-ketamine and midazolam-ketamine in preoperative sedation in pediatric
Public title
Comparison efficacy of nebulized Dexmedetomidine-ketamine and midazolam-ketamine in preoperative sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I and II
Children aged 3-7 years3
Elective eye surgery under general anesthesia
Exclusion criteria:
Hepatic renal failure
Neurologic disease
Asthma
Age
From 3 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To ensure an equal number of participants in each group, a total of 60 people were selected for the study. We used a computer randomization table and the block method for random sequence generation, using EXCEL 2016. Here's how it worked: first, a random sequence was created, and then 60 envelopes were prepared, each containing a card with one of the random sequences. To maintain the randomness, we numbered the envelopes sequentially on the outside and sealed them to prevent any visibility of their contents. The sealed envelopes were then placed in a box. When participants were eligible to enter the study, we opened the envelopes in the order of their entry, revealing the assigned group for each participant.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is randomized double-blind because both the patients, the anesthesiologist responsible for data collection and scoring based on the questionnaires, the leading researcher, and the operating room personnel, including the anesthetist, recovery nurse, operating room expert, and those who prepared the draft of the article. They are kept blind. An independent investigator not involved in the study opens the envelopes one hour before the start of anesthesia, and the drugs are prepared in identical syringes with matching random codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Farabi Hospital, Tehran University of Medical Sciences
Street address
Farabi Hospital, South Kargar St., Qazvin Square
City
Tehran
Province
Tehran
Postal code
1336616351
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.TUMS.FARABIH.REC.1403.013
Health conditions studied
1
Description of health condition studied
efficacy of preoperative sedation for pediatric ophthalmic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation
Timepoint
Minutes fifteen and thirty
Method of measurement
The degree of sedation is evaluated using the RAMSAY sedation scale.1: Patient is anxious, agitated or restless, or both. 2: Patient is oriented, co-operative and tranquil. 3: Patient responds to commands only. 4: Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. 5: Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. 6: Patient exhibits no response
2
Description
Mask Acceptance
Timepoint
Minutes fifteen and thirty
Method of measurement
The acceptability of the face mask is determined based on the above Corda system: Excellent= Acceptance without any complaint; Good= Compliant, momentarily teary but then agreed to take medication; Fair= Complaint, initially disobedient but eventually agreed to take medication; Poor= Refuse medication
3
Description
Parental separation
Timepoint
Minutes fifteen and thirty
Method of measurement
At 0 and 15 minutes, separation anxiety is assessed using the Point Parental Separation Anxiety Scale (PSAS). 1. Easily detachable; 2. Moaning but confident; 3. She cries and can't be sure, clinging to her parents; 4. He cries and clings to his parents.
4
Description
Determining the prevalence of nausea and vomiting after receiving medication
Timepoint
Minutes 0 and 15 and during postoperative recovery
Method of measurement
Minutes 0 and 15 minutes and during the recovery after the operation will be recorded by the doctor in the relevant form
Secondary outcomes
empty
Intervention groups
1
Description
The patients are divided into two groups: the intervention group includes patients with nebulized midazolam-ketamine. In the midazolam-ketamine nebulized group, it is 0.3 mg per kg of midazolam and 3 mg per kg of ketamine and in 2 cc of normal saline. Patients are allowed to consume clear liquids up to 2 hours before surgery and solid or semi-solid foods up to 8 hours before surgery. Regular monitoring (plus oximetry, non-invasive blood pressure, and EKG) is done in the pre-anesthesia room with a guardian, and children are given nebulizers 15 minutes before the operation. A typical hospital jet nebulizer comes with a mouthpiece that injects 100% oxygen continuously at 10 liters per minute. The nurse guarantees the correct use of the nebulizer and the final administration of the solution. The degree of sedation is evaluated using the RAMSAY sedation scale.
Category
Treatment - Drugs
2
Description
Control group: includes patients who are going to take nebulized dexmedetomidine-ketamine. In the group, dexmedetomidine DK is 2 micrograms per kilogram and ketamine is 3 mg per kilogram in 2 cc of normal saline. Patients are allowed to consume clear liquids up to 2 hours before surgery, as well as solid or semi-solid foods up to 8 hours before surgery. Regular monitoring (plus oximetry, non-invasive blood pressure and EKG) is done in the pre-anesthesia room with the presence of a guardian and children are given nebulizer 15 minutes before the operation. A typical hospital jet nebulizer comes with a mouthpiece that injects 100% oxygen continuously at a rate of 10 liters per minute. The correct use of the nebulizer and the final administration of the solution are guaranteed by the nurse. The degree of sedation is evaluated using the RAMSAY sedation scale.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Abbas Ostadalipour
Street address
South Kargar St., Qazvin Square.
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Email
farabih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Building of Vice chancellor for Research, Tehran University of Medical Sciences and Health Services., Ghods St., Cross, Keshavarz Blvd.,
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۹۳۵۸۴۰
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Abbas Ostadalipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
South Kargar St., Qazvin Square
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 8856 3811
Email
a-ostadalipour@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Ostadalipour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
South Kargar St. - Qazvin Square
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Email
a-ostadalipour@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Ostadalipour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
South Kargar St., Qazvin Square
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Email
a-ostadalipour@tums.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
No - There is not 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
Part of the data, such as information related to the main outcome or similar, can be shared.
When the data will become available and for how long
After printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Non-identifiable personal data or other documentation for larger studies
From where data/document is obtainable
Applicants can email the project manager, Dr.Ostadalipour, at a-ostadalipour@tums.ac.ir to receive the desired documents or data.
What processes are involved for a request to access data/document
Applicants can email the responsible author at a-ostadalipour@tums.ac.ir to receive the desired documents or data and describe the required study and information.