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IRCT20230204057318N2 IRCT 2023-07-16 Shahid Beheshti University of Medical Sciences Investigating the effect of simultaneous infusion of lidocaine and ketamine compared to single infusion of lidocaine and ketamine on neuromonitoring in spine surgeries Investigating the effect of simultaneous infusion of lidocaine and ketamine compared to single infusion of lidocaine and ketamine on neuromonitoring in spine surgeries 2023-07-23 anticipated 90 Complete https://irct.ir/trial/71283 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a simple randomization method was used using a table of random numbers and through the Random generator program of the Android version. In this randomization, patients who meet the criteria for entering the study are assigned a number before anesthesia, which will represent one of the three study groups. Based on this number, special medicine will be started for the patients, Blinding description: Due to the fact that the patients are unaware of the drug content, they are blinded to their group. Also, the drugs were prepared by a person outside the study group and the treatment group of patients with numbers, so the treatment group is also unaware of the colorless drug content in the 50 cc syringe. Also, the person who measures pain, nausea, and agitation in recovery is also blinded to the patient group. The data analyst will not know about the coding of the groups. 3 Neuromonitoring status in spine surgeries. Intervention 1: Intervention group: After general anesthesia in the ketamine group, 0.3 mg/kg/h of ketamine will be administered during the operation and will be stopped at the beginning of skin closure. Intervention 2: Intervention group: After general anesthesia in the lidocaine group, 1mg/kg/h of lidocaine will be administered during the operation and will be stopped at the beginning of skin closure. Intervention 3: Intervention group: After general anesthesia in the mixed group, 1mg/kg/h of lidocaine and 0.3 mg/kg/h of ketamine will be administered during the operation and will be stopped at the beginning of skin closure. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Alireza Shakeri
Imam Hossein Hospital, Shahid Madani st, Imam Ali Hwy.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences scientific Alireza Shakeri
Imam Hossein Hospital, Shahid Madani st, Imam Ali Hwy.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 dr.alirezashakeri@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Candidate patients for spine surgery under neuromonitoring Age 18 to 65 years Patients with ASA class 1 or 2 18 years 65 years Both Absence of any significant laboratory disturbance in coagulation, kidney, liver function tests, blood cell count No history of drug addiction Insensitivity to ketamine or local anesthetics Absence of contraindications for performing MEP (epilepsy, cerebral cortex damage, increased intracranial pressure, cardiac pacemaker, intracranial electrodes, or vascular clamps) M43.2 Fusion of spine Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: After general anesthesia in the ketamine group, 0.3 mg/kg/h of ketamine will be administered during the operation and will be stopped at the beginning of skin closure. Intervention group: After general anesthesia in the lidocaine group, 1mg/kg/h of lidocaine will be administered during the operation and will be stopped at the beginning of skin closure. Intervention group: After general anesthesia in the mixed group, 1mg/kg/h of lidocaine and 0.3 mg/kg/h of ketamine will be administered during the operation and will be stopped at the beginning of skin closure. Latency and amplitude changes in neuromonitoring. Timepoint: During surgery. Method of measurement: Analysis of neural wave diagram. Intraoperative hemodynamic. Timepoint: During surgery. Method of measurement: Hemodynamic monitoring device. Intraoperative hemorrhage. Timepoint: During surgery. Method of measurement: Suction bottle and gauzes. Emergence time from anesthesia. Timepoint: During surgery. Method of measurement: Chronometer. Pain in the recovery room. Timepoint: Recovery. Method of measurement: Visual Analogue Scale (VAS). First time of analgesia request. Timepoint: Post surgery. Method of measurement: Watch. Postoperative nausea and vomiting. Timepoint: Recovery room. Method of measurement: Questionary. Sedation - agitation status. Timepoint: Recovery room. Method of measurement: Riker Sedation- Agitation Scale. Shahid Beheshti University of Medical Sciences Approved 2023-06-27 Ethics Committee of Shahid Beheshti University of Medical Sciences Yaman st., Shahid Chamran Hwy. Tehran Tehran Iran (Islamic Republic of)