]>
IRCT20250722066589N4 IRCT 2026-02-03 Shahid Beheshti University of Medical Sciences Effect of Perioperative Lidocaine versus Dexmedetomidine on Depressive Symptoms and Sleep Quality Following Breast Cancer Surgery Effect of Perioperative Lidocaine versus Dexmedetomidine on Depressive Symptoms and Sleep Quality Following Breast Cancer Surgery 2026-01-31 anticipated 120 Complete https://irct.ir/trial/88802 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation list is generated using block randomization with random number generator software, employing fixed or variable block sizes (e.g., 4 and 6) to ensure balanced patient numbers between groups. Allocation codes are placed in sequentially numbered, opaque, light-proof envelopes prepared by an independent individual uninvolved in patient treatment or evaluation. Only the admitting personnel in the operating room may open the envelope corresponding to the patient's number, Blinding description: This study employs a double-blind design, ensuring that patients and outcome assessors are unaware of the intervention type. An anesthesia nurse, independent of the data collection team, prepares lidocaine and dexmedetomidine to be identical in appearance (50 mL volume and color) and administers them via identically labeled syringes or infusion pumps with a random code. The research team will remain blinded until the observation period concludes, unless anesthesiologists detect clear signs of systemic toxicity or cardiovascular complications (e.g., severe bradycardia or hypotension). 3 Condition 1: Breast Cancer. Condition 2: Depressive episode. Condition 3: Sleep disorders. Condition 4: Generalized Anxiety Disorder. Intervention 1: The intervention group will receive intravenous dexmedetomidine. After induction of anesthesia, dexmedetomidine will be administered at a dose of 1 microgram per kilogram, followed by continuous infusion at a rate of 0.5–1 microgram per kilogram per hour until discharge from the recovery room. Intervention 2: The control group will receive intravenous lidocaine. After induction of anesthesia, lidocaine will be administered at a dose of 1.5 mg per kilogram as a loading dose, followed by continuous infusion at a rate of 1.5–2 mg per kilogram per hour until discharge from the recovery room. Yes - There is a plan to make this available What will be shared: All data collected from the study population can potentially be shared after de‑identification of individuals. When: The access period begins 6 months after publication of the results To whom: Study data will be available to researchers employed in academic and scientific institutions, and also to those employed in industry. Conditions: All data from our study will be available to researchers employed in academic and scientific institutions, and individuals working in industry may also apply to obtain access to the data. Where to obtain: Dr Mlihe Abniki How to obtain: Data will be available six months after publication via email or written request. Comments:
public Malihe Abniki
Anesthesiology of Department , 4th Floor , Shihada-y Tajrish Hospital , Valiasr Street
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 dr.abniki@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Malihe Abniki
Anesthesiology of Department , 4th Floor , Shihada-y Tajrish Hospital , Valiasr Street
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 dr.abniki@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Mild to severe anxiety or depression symptoms Without systemic disease, or with controlled systemic disease 18 years 60 years Female Patients with incomplete clinical data severe cardiac disease increased intracranial pressure epilepsy incomplete clinical data failure to complete the one‑week follow‑up allergy to intravenous anesthetic agents C50 F06.32 G47 F41.1 Malignant neoplasm of breast Mood disorder due to known physiological condition with major depressive-like episode Sleep disorders Generalized anxiety disorder Treatment - Drugs Treatment - Drugs The intervention group will receive intravenous dexmedetomidine. After induction of anesthesia, dexmedetomidine will be administered at a dose of 1 microgram per kilogram, followed by continuous infusion at a rate of 0.5–1 microgram per kilogram per hour until discharge from the recovery room. The control group will receive intravenous lidocaine. After induction of anesthesia, lidocaine will be administered at a dose of 1.5 mg per kilogram as a loading dose, followed by continuous infusion at a rate of 1.5–2 mg per kilogram per hour until discharge from the recovery room. Changes in NRS scores, opioid use, and adverse events (including cardiac complications, nausea, and dizziness). Timepoint: During the first 24 hours after surgery. Method of measurement: Numerical Rating Scale. Depressive symptoms. Timepoint: on postoperative days 1, 3, and 7. Method of measurement: Patient Health Questionnaire–9 (PHQ‑9). Postoperative sleep quality improvement based on PSQI score. Timepoint: on postoperative days 1, 3, and 7. Method of measurement: The Pittsburgh Sleep Quality Index (PSQI) questionnaire. Anxiety symptoms. Timepoint: on postoperative days 1, 3, and 7. Method of measurement: The 7-item Generalized Anxiety Disorder (GAD-7). Shahid Beheshti University of Medical Sciences Approved 2026-01-11 Research Ethics Committees of Vice-Chancellor in Research Affairs-Shahid Beheshti University of Medi 5th Floor , Vic President for Research and Tecnology , Shahid Beheshti University of Medical Sciences, Arabi Street, Yemen Street Tehran Tehran Iran (Islamic Republic of)