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IRCT20121205011676N7 IRCT 2024-09-23 Tehran University of Medical Sciences Comparison efficacy of nebulized Dexmedetomidine-ketamine and midazolam-ketamine in preoperative sedation Comparison efficacy of nebulized Dexmedetomidine-ketamine and midazolam-ketamine in preoperative sedation in pediatric 2024-08-05 anticipated 60 Complete https://irct.ir/trial/77817 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 efficacy of preoperative sedation for pediatric ophthalmic surgery. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Part of the data, such as information related to the main outcome or similar, can be shared. When: After printing the results To whom: Researchers working in academic and scientific institutions Conditions: Non-identifiable personal data or other documentation for larger studies Where to obtain: Applicants can email the project manager, Dr.Ostadalipour, at a-ostadalipour@tums.ac.ir to receive the desired documents or data. How to obtain: 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. Comments:
public Abbas Ostadalipour
South Kargar St., Qazvin Square
Tehran Iran (Islamic Republic of) 1336616351 +98 21 8856 3811 a-ostadalipour@tums.ac.ir Tehran University of Medical Sciences scientific Abbas Ostadalipour
South Kargar St. - Qazvin Square
Tehran Iran (Islamic Republic of) 1336616351 +98 21 5540 0003 a-ostadalipour@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) ASA I and II Children aged 3-7 years3 Elective eye surgery under general anesthesia 3 years 7 years Both Hepatic renal failure Neurologic disease Asthma Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. 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. 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. Tehran University of Medical Sciences Approved 2024-05-11 Research Ethics Committees of Farabi Hospital, Tehran University of Medical Sciences Farabi Hospital, South Kargar St., Qazvin Square Tehran Tehran Iran (Islamic Republic of)