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IRCT20250608066112N1 IRCT 2025-08-04 Alborz University Of Medical Sciences Oxytocin versus lidocaine for controlling hemodynamic response during intubation OL-HemoTrial (Oxytocin–Lidocaine Hemodynamic Trial) Comparison of the effects of intravenous oxytocin and lidocaine on hemodynamic responses during laryngoscopy and tracheal intubation in adult patients undergoing elective surgery: A triple-blind randomized controlled trial 2025-07-23 anticipated 60 Complete https://irct.ir/trial/84324 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple individual randomization will be used. The random allocation sequence will be generated using a computer-based random number generator. For allocation concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) will be utilized. Each envelope will contain a coded drug vial, which will be prepared by an independent person not involved in the study. The envelopes will be handed to a nurse who will be unaware of the intervention type. Outcome assessors will also be blinded to the group allocation. No stratification will be applied, but age and gender balance between groups will be maintained as much as possible, Blinding description: In this study, participants, care providers (including the administering nurse), investigators, outcome assessors, and data analysts will be blinded to group assignments. The study medications (oxytocin and lidocaine) will be prepared in identical coded vials by an independent individual not involved in the study. Each participant’s assigned intervention will be placed in a sequentially numbered, opaque, sealed envelope (SNOSE) and handed to the nurse responsible for injection. The outcome parameters (blood pressure, heart rate, ECG changes, etc.) will be measured by assessors unaware of the treatment allocation. Group codes will remain concealed from all parties until after data analysis is completed, ensuring full triple-blinding. 3 Hemodynamic responses to laryngoscopy and endotracheal intubation under general anesthesia. Intervention 1: Intervention group: Patients in this group will receive lidocaine at a dose of 1.5 mg per kilogram of body weight administered as a slow intravenous injection one to two minutes prior to endotracheal intubation. The lidocaine solution will be 2% lidocaine hydrochloride manufactured by Caspian Pharmaceutical Company. The injection will be performed by a nurse anesthetist who will be blinded to the group assignment of the patient. Intervention 2: Intervention group: Patients in this group will receive magnesium sulfate at a dose of 30 mg per kilogram of body weight, administered as an intravenous infusion over 10 minutes, starting one to two minutes before endotracheal intubation. The magnesium sulfate solution used will be 20% concentration manufactured by Shahid Ghazi Pharmaceutical Company. The infusion will be administered by a nurse anesthetist who is blinded to the patient's group assignment. Yes - There is a plan to make this available What will be shared: Individual participant data (IPD), study protocol, informed consent form, statistical analysis plan, clinical study report, statistical analysis codes, and data dictionary; all documents will be anonymized and made available after completion of the trial. When: Data and documents will be available starting 6 months after the publication of the final manuscript, for a period of 5 years. To whom: Academic researchers, investigators from recognized research institutions, PhD and post-doctoral students for independent academic research. Conditions: Use is limited to independent academic analysis with a sound methodological proposal. Commercial use or redistribution of the data is prohibited without written permission. Where to obtain: Requests should be sent to the corresponding author of the study, Dr. Mehdi Rezaei. How to obtain: The request will undergo initial screening. Upon approval, a data confidentiality agreement will be issued. Once signed, access will be granted within 10 working days. Comments:
public Mahdi Rezai
Alborz University Of Medical Sciences, Taleghani Sq, North Taleghani Blvd.
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3419 7000 anesthesia.practitioner@gmail.com Alborz University Of Medical Sciences scientific Mahdi Rezai
Alborz University Of Medical Sciences, Taleghani Sq, North Taleghani Blvd.
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3419 7000 anesthesia.practitioner@gmail.com Alborz University Of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years Candidates for elective surgery requiring intubation and laryngoscopy ASA physical status class I and II Written informed consent for participation No contraindication to lidocaine or oxytocin No known allergy to standard anesthetic agents Systolic blood pressure >90 mmHg and heart rate >60 bpm 18 years 65 years Both Pregnancy History of cardiovascular diseases (e.g. arrhythmia or tachycardia) Chronic respiratory diseases Neurological disorders Hepatic or renal disease History of substance abuse or stimulant use Anticipated difficult intubation (e.g. short neck, large tongue, small jaw) Known allergy to lidocaine or oxytocin R00.1 Bradycardia, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group will receive lidocaine at a dose of 1.5 mg per kilogram of body weight administered as a slow intravenous injection one to two minutes prior to endotracheal intubation. The lidocaine solution will be 2% lidocaine hydrochloride manufactured by Caspian Pharmaceutical Company. The injection will be performed by a nurse anesthetist who will be blinded to the group assignment of the patient. Intervention group: Patients in this group will receive magnesium sulfate at a dose of 30 mg per kilogram of body weight, administered as an intravenous infusion over 10 minutes, starting one to two minutes before endotracheal intubation. The magnesium sulfate solution used will be 20% concentration manufactured by Shahid Ghazi Pharmaceutical Company. The infusion will be administered by a nurse anesthetist who is blinded to the patient's group assignment. Change in patients' systolic blood pressure following endotracheal intubation. Timepoint: Systolic blood pressure will be measured before administration of intervention, immediately before endotracheal intubation, and at one, three, and five minutes after intubation. Method of measurement: Systolic blood pressure will be measured using a non-invasive hospital-grade blood pressure monitor. Change in patients' diastolic blood pressure following endotracheal intubation. Timepoint: Before intervention, immediately before intubation, and at one, three, and five minutes after intubation. Method of measurement: Measured using a non-invasive hospital-grade blood pressure monitor. Change in patients' heart rate following endotracheal intubation. Timepoint: Before intervention, immediately before intubation, and at one, three, and five minutes after intubation. Method of measurement: Measured using hospital electrocardiographic heart rate monitor. Occurrence of cardiac arrhythmias following endotracheal intubation in patients receiving lidocaine or oxytocin. Timepoint: From the beginning of intervention up to five minutes after intubation. Method of measurement: Continuous monitoring using hospital electrocardiographic system. Change in mean arterial blood pressure (MAP) following endotracheal intubation. Timepoint: Before intervention, immediately before intubation, and at one, three, and five minutes after intubation. Method of measurement: Calculated from systolic and diastolic values measured using a non-invasive monitor. Alborz University Of Medical Sciences Approved 2025-05-24 Research Ethics Committee of Alborz University of Medical Sciences Alborz University of Medical Sciences, Taleghani Sq., North Taleghani Blvd. Karaj Alborz Iran (Islamic Republic of)