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

Clinical trial with 3 groups, with parallel groups, triple blind, randomized, phase 3 on 90 patients. For randomization, a simple randomization method is used using a table of random numbers.

After the approval of the ethics committee and obtaining the consent of the patients, 90 candidates for spine surgery in Imam Hossein Hospital who meet the entry criteria will be included in the study. Patients are assigned to one of the 3 groups by simple randomization method. Individuals responsible for randomization from the research team will not be responsible for examining the dependent variable. The data analyst will not know about the coding of the groups.

Candidate patients for spine surgery under neuromonitoring with the following criteria Age 18 to 65 years Patients with ASA class 1 or 2 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)

After undergoing general anesthesia, patients are assigned to one of three groups: ketamine, lidocaine, or simultaneous infusion, which are administered during the operation. The infusion is halted at the onset of skin closure.

Latency and amplitude changes in neuromonitoring

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.

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.

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