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IRCT20211023052849N3 IRCT 2022-06-08 Tehran University of Medical Sciences The effect of anesthesia types on cognitive disorders after spinal surgery Evaluation of postoperative cognitive disorders in non-emergent spinal surgery patients undergoing intravenous and isoflurane anesthesia 2022-02-24 anticipated 65 Complete https://irct.ir/trial/61846 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This research uses individual randomization method. The random number sequence is generated using the "Randomization.com" website with a simple randomization method. The rest of the patients are in the group of total intravenous anesthesia (TIVA). Anesthesia is performed by an anesthesiologist and a second anesthesiologist who is not aware of the patients' randomization examines the patients for cognitive impairment, Blinding description: The patient's physician, who is the lead researcher, induces anesthesia, and the second anesthesiologist, who has no knowledge of patient's randomization, examines patients for cognitive impairment. N/A Spine surgery. Intervention 1: Group 1 will be patients who are candidates for elective spinal surgery and will receive anesthesia with complete intravenous drugs by propofol induction dose(2-2.5 mg/kg IV) .After induction of anesthesia, patients received propofol as a continuous injection (using an infusion pump) at a dose of 50 to 100 μg / kg / min to maintain anesthesia. Proposol brand was BBRAUN (Germany). Intervention 2: Group 2 will be patients who are candidates for elective spinal surgery and will receive 1.5 - 3 % isoflurane anesthesia.After induction of anesthesia, isoflurane inhaled anesthetic gas with MAC 1.2 to 2% (by Drager anesthesia machine) was used to maintain anesthesia. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Access starting after publication To whom: Clinical researchers and physicians Conditions: Decision upon request Where to obtain: Via email of Dr Arash Heroabadi aheroabadi@sina.tums.ac.ir How to obtain: Formal inquiry. Comments:
public Arash Heroabadi
Shariati Hospital, Jalal-al ahmad street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 arash.heroabadi@gmail.com Tehran University of Medical Sciences scientific Arash Heroabadi
Shariati Hospital, Jalal-al ahmad street, North Kargar street
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 arash.heroabadi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) ≥ 18 years of age and maximum 65 Class 1 to 3 ASA anesthesia Absence of heart failure (EF <20%) No uncontrolled blood pressure or diabetes No pregnancy Willingness and satisfaction to participate in the project 18 years 65 years Both Emergent surgery Patient dissatisfaction with continued participation in the study Pregnant women History of using psychiatric medications History of dementia History of brain surgery History of schizophrenia Recent alcohol or opioid use Severe anxiety Mental retardation Recent stroke S24.2XXD Injury of nerve root of thoracic spine, subsequent encounter Treatment - Drugs Treatment - Drugs Group 1 will be patients who are candidates for elective spinal surgery and will receive anesthesia with complete intravenous drugs by propofol induction dose(2-2.5 mg/kg IV) .After induction of anesthesia, patients received propofol as a continuous injection (using an infusion pump) at a dose of 50 to 100 μg / kg / min to maintain anesthesia. Proposol brand was BBRAUN (Germany). Group 2 will be patients who are candidates for elective spinal surgery and will receive 1.5 - 3 % isoflurane anesthesia.After induction of anesthesia, isoflurane inhaled anesthetic gas with MAC 1.2 to 2% (by Drager anesthesia machine) was used to maintain anesthesia. Cognitive disorders. Timepoint: Before induction of anesthesia, 6 ,12 , and 24 hours after Recovery. Method of measurement: Mini Mental State Examination questionnaire. Tehran University of medical sciences Approved 2020-09-29 Ethics Committee of Tehran University of Medical Sciences Keshavarz Blvd, Qarib street Tehran Tehran Iran (Islamic Republic of)