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IRCT20241214064051N4 IRCT 2025-05-12 Babol University of Medical Sciences Effect of ketamine administered into the trachea on sore throat after spinal surgery under general anesthesia The effect of endotracheal administration of ketamine on sore throat after spinal surgery in patients under general anesthesia with endotracheal intubation: A randomized clinical trial 2025-05-26 anticipated 34 Complete https://irct.ir/trial/82973 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a double-blind, randomized, placebo-controlled, superiority clinical trial conducted at a single center. Randomization is performed using a computer-generated random number table. The intervention is administered preoperatively. Sore throat severity is assessed using a standardized 4-point scale at multiple time intervals postoperatively (1, 6, 24, 36, 48, 60, and 72 hours), Randomization description: Patients who meet the inclusion criteria will be randomly assigned to two groups (ketamine or normal saline) in a 1:1 ratio using a computer-generated random number table. Each patient will receive a study drug according to a pre-coded syringe labeled with a 3-digit code, prepared in advance. The sequence of group allocation will be determined before the start of the study and followed throughout enrollment, Blinding description: This study is designed as a double-blind randomized clinical trial. The patients, care providers, and outcome assessors are blinded to the group allocation. The study drugs (ketamine or normal saline) are prepared in identical syringes labeled with a unique 3-digit code. An anesthesia technician not involved in patient evaluation administers the drug according to the randomization list. Neither the patient nor the evaluating anesthesiology resident knows which drug has been administered. The codes will be revealed only after data collection is completed for all participants. 3 Postoperative sore throat following general anesthesia with endotracheal intubation. Intervention 1: Intervention group: The intervention group will receive 2 mL of ketamine with a concentration of 5 mg/mL, administered into the endotracheal tube immediately before intubation, as a single preoperative dose. Intervention 2: Control group: The control group will receive 2 mL of normal saline administered into the endotracheal tube immediately before intubation, as a single preoperative dose. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make the individual participant data (IPD) available. The decision will depend on future considerations including ethical approvals and data sharing policies. There is no further information
public Maryam Khoshnevis
School of Medicine, Babol University of Medical Sciences, Ganj Afrooz Street, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 4717648991 +98 911 218 2557 maryamkhoshnevis8@gmail.com Babol University of Medical Sciences scientific Maryam Khoshnevis
School of Medicine, Babol University of Medical Sciences, Ganj Afrooz Street, Babol, Mazandaran, Iran
Babol Iran (Islamic Republic of) 4717648991 +98 911 218 2557 maryamkhoshnevis8@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 60 years ASA physical status class I or II Candidates for elective spinal surgery in the prone position Under general anesthesia with endotracheal intubation Signed written informed consent 20 years 60 years Both History of sore throat before surgery Patients with asthma or COPD Smokers Recent use of NSAIDs Patient unwilling to participate in the study Known allergy to ketamine or normal saline Mallampati score greater than 2 More than one attempt required for endotracheal intubation Intubation time exceeding 20 seconds R07.0 Pain in throat Prevention Placebo Intervention group: The intervention group will receive 2 mL of ketamine with a concentration of 5 mg/mL, administered into the endotracheal tube immediately before intubation, as a single preoperative dose. Control group: The control group will receive 2 mL of normal saline administered into the endotracheal tube immediately before intubation, as a single preoperative dose. The primary outcome variable is the incidence of postoperative sore throat. It is measured using a 4-point severity scale at 1, 6, 24, 36, 48, 60, and 72 hours after extubation. The sample size was calculated based on expected differences in the incidence of sore throat between the ketamine and placebo groups. Timepoint: 1, 6, 24, 36, 48, 60, and 72 hours after extubation. Method of measurement: Sore throat will be measured using a standardized 4-point verbal rating scale, where 0 = no pain, 1 = mild, 2 = moderate, and 3 = severe. Severity of postoperative sore throat will be evaluated using a 4-point verbal rating scale to assess the impact of intervention on pain intensity. Timepoint: 1, 6, 24, 36, 48, 60, and 72 hours after extubation. Method of measurement: 4-point verbal rating scale (0 = no pain, 1 = mild, 2 = moderate, 3 = severe). Time of onset of postoperative sore throat will be recorded in hours after extubation, based on patient self-report, to evaluate the delay in symptom appearance due to the intervention. Timepoint: Continuously assessed within the first 72 hours after extubation. Method of measurement: Patient self-report recorded via a structured questionnaire. Babol University of Medical Sciences Approved 2024-03-05 Ethics Committee of Babol University of Medical Sciences School of Medicine, Babol University of Medical Sciences, Ganj Afrooz Street, Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)