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IRCT20220302054164N1 IRCT 2022-04-06 Arak University of Medical Sciences Comparison of effect of ketamine and lidocaine on prevention of emergence agitation in Rhinoplasty Comparison of effect of ketamine and lidocaine on prevention of emergence agitation in Rhinoplasty 2022-04-04 anticipated 72 Complete https://irct.ir/trial/62256 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization method is to flip a coin and based on the sample size, the same number of coins will be thrown. If head is observed, the patient will be in the ketamine group and otherwise in the lidocaine group, Blinding description: This randomized study is one side blinded because the patient does not know which treatment or medication he/she is receiving. 3 rhinoplasty surgery. Intervention 1: Intervention group: Intervention group: Lidocaine group: 1.5 mg / kg lidocaine intravenously 20 minutes before surgery completion. Intervention 2: Intervention group: Intervention group: Ketamine group: 5 /. Mg / kg of ketamine 20 minutes before surgery completion. Intervention 3: Control group: 20 minutes before surgery completion to patients in the control group 1 ml of normal saline intravenously. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Safoora Omidvar
Sardasht
Arak Iran (Islamic Republic of) 3815697854 +98 71 5335 2678 s_omidvar1991@yahoo.com Arak University of Medical Sciences scientific Safoora Omidvar
Sardasht
Arak Iran (Islamic Republic of) 3815697854 +98 86 3417 3526 s_omidvar1991@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Referral for elective rhinoplasty surgery Age 18-45 years Lack of known allergies to the drugs used in the present study No pregnancy No drug addiction Do not use psychotropic drugs Perform surgery under general anesthesia Classification of ASA class, I-II 18 years 45 years Both Taking painkillers and sedatives 24 hours before surgery History of heart disease, nervous system, and neurological disorders Patient with a history of previous rhinoplasty History of seizures Duration of anesthesia and surgery more than 2 hours J95-J95 Intraoperative and postprocedural complications and disorders of the respiratory system, not elsewhere classified Prevention Prevention Placebo Intervention group: Intervention group: Lidocaine group: 1.5 mg / kg lidocaine intravenously 20 minutes before surgery completion Intervention group: Intervention group: Ketamine group: 5 /. Mg / kg of ketamine 20 minutes before surgery completion Control group: 20 minutes before surgery completion to patients in the control group 1 ml of normal saline intravenously Restlessness when waking up from anesthesia. Timepoint: During anesthesia until the end of the patient's presence in the recovery room, the patient's vital signs will be measured. Also, during the presence at recovery, the RASS and NRS questionnaires will be filled in. Method of measurement: After extubation and transfer of the patient to recovery room, the patient's restlessness will be recorded by the RASS scale every 10 minutes until discharge from the recovery by a trained nurse who does not know the patient group. Also, after transferring the patient to recovery room, the amount of postoperative pain will be recorded by the Numerical Pain Measurement Scale (NRS) every 10 minutes. Arak University of Medical Sciences Approved 2022-01-22 Ethics committee of Arak University of Medical sciences Sardasht Arak Markazi Iran (Islamic Republic of)