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IRCT20210415050983N2 IRCT 2022-01-09 Shahid Beheshti University of Medical Sciences A Comparison of the effect of dexmedetomidine and remifentanil on analgesia and respiratory parameters in patients undergoing stereotactic brain biopsy A Comparison of the effect of dexmedetomidine and remifentanil on analgesia and respiratory parameters in patients undergoing stereotactic brain biopsy 2021-12-22 anticipated 40 Complete https://irct.ir/trial/60399 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: En Permuted Randomized Blocks :In this method, 10 random blocks are generated by computer. Each block includes 5 people in the intervention group and 5 people in the control group. The order of these people is randomly arranged by computer and people are assigned to groups in the same way. At the end of each block, a new block of 10 is produced and this process will continue until the final sample volume is reached, Blinding description: Forms with numbers 1 and 2 are used in packaged envelopes to group patients, which are given to patients randomly and patients do not know about the envelopes. After entering the envelope operating room by the anesthesiologist in charge of the patient Opened and according to the intervention group, the drug that was prepared in advance is given to the clinical caregiver for injection. The clinical caregiver is not aware of the grouping. The evaluator and recorder of the results and the person analyzing the data are also unaware of the grouping. 2 Stereotactic biopsy. Intervention 1: First, under local anesthesia of the scalp with 20 cc of 1.5% lidocaine and 50 micrograms of intravenous fentanyl, a stereotactic form is installed for the patient and the patient is transferred to radiology for MRI. Then 2 liters of oxygen per minute with a mask, 5 cc of normal saline per hour and 0.003 mg per kg of intravenous midazolam are given. Group D receive intravenous dexmedetomidine at the rate of 0.5 micrograms per kg per 10 minutes for 10 minutes. Then 0.5 micrograms per kilogram per hour is given by the infusion pump during the procedure. Intervention 2: First, under local anesthesia of the scalp with 20 cc of 1.5% lidocaine and 50 micrograms of intravenous fentanyl, a stereotactic form is installed for the patient and the patient is transferred to radiology for MRI. Then 2 liters of oxygen per minute with a mask, 5 cc of normal saline per hour and 0.003 mg per kg of intravenous midazolam are administered. Group R Remifentanil 1 microgram per kilogram of bolus and then 0.05 to 0.2 micrograms per kilogram. Receives grams per minute by infusion pump. Yes - There is a plan to make this available What will be shared: En All data(questionnaire and the Excel file) can be shared after identifying individuals. When: Start access 6 months after printing results To whom: En Researchers working in academic institutions Conditions: En If the study is conducted in a larger area between several hospitals Where to obtain: En Email: drasgari98429@gmail.com Phone : 09127421711 Mrs. Dr. Sogol Asgari How to obtain: En After identifying the people, the questionnaire and the Excel file will be sent via e-mail within a week. Comments:
public Sogol Asgari
South Kargar St. Kamali St. Special Loghman Hakim Hospital
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 drasgari98429@gmail.com Shahid Beheshti University of Medical Sciences scientific Faranak Behnaz
Valiasr St. Tajrish Square (Quds)
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 Faranak.behnaz@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients 18-50 years old candidate for stereotactic Patients with supratentorial lesions with or without hydrocephalus No dysfunction of the liver and kidneys No drug addiction Consent to participate in the study 18 years 50 years Both BMI >35 or<16 mental disorder Uncontrolled epilepsy Alcohol and drug abuse Having a comorbid condition such as high blood pressure History of chronic pain Patients with brainstem lesions Intubated patients N/A N/A First, under local anesthesia of the scalp with 20 cc of 1.5% lidocaine and 50 micrograms of intravenous fentanyl, a stereotactic form is installed for the patient and the patient is transferred to radiology for MRI. Then 2 liters of oxygen per minute with a mask, 5 cc of normal saline per hour and 0.003 mg per kg of intravenous midazolam are given. Group D receive intravenous dexmedetomidine at the rate of 0.5 micrograms per kg per 10 minutes for 10 minutes. Then 0.5 micrograms per kilogram per hour is given by the infusion pump during the procedure. First, under local anesthesia of the scalp with 20 cc of 1.5% lidocaine and 50 micrograms of intravenous fentanyl, a stereotactic form is installed for the patient and the patient is transferred to radiology for MRI. Then 2 liters of oxygen per minute with a mask, 5 cc of normal saline per hour and 0.003 mg per kg of intravenous midazolam are administered. Group R Remifentanil 1 microgram per kilogram of bolus and then 0.05 to 0.2 micrograms per kilogram. Receives grams per minute by infusion pump. Hemodynamic parameters. Timepoint: Every 5 minutes from the moment you enter the operating room. Method of measurement: monitoring. Respiratory parameters. Timepoint: Every 5 minutes from the moment you enter the operating room. Method of measurement: monitoring. Seadation. Timepoint: Every 5 minutes from the moment you enter the operating room. Method of measurement: Ramssy Criteria. Analgesia. Timepoint: Every 5 minutes from the moment you enter the operating room. Method of measurement: VAS criteria. Recovery from sedation. Timepoint: Every 10 minutes after the procedure. Method of measurement: Aldert criteria. Shahid Beheshti University of Medical Sciences Approved 2021-12-01 Vice for Research and Technology, Shahid Beheshti University of Medical Sciences Velenjak, Yemen Street, Shahid Shahriari Square Tehran Tehran Iran (Islamic Republic of)