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IRCT20180416039326N25 IRCT 2025-10-14 Esfahan University of Medical Sciences The effect of intravenous lidocaine and dexamethasone injection on endotracheal tube removal time and quality of postoperative recovery in elderly patients. Comparison of the effect of intravenous lidocaine and dexamethasone on extubation time and postoperative complications in elderly patients undergoing vitrectomy: a randomized clinical trial 2025-11-06 anticipated 60 Complete https://irct.ir/trial/86100 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random Allocation Software will be used to allocate patients undergoing vitrectomy to either lidocaine (Group A) or dexamethasone (Group B). An eligible patient list will be created and numbered, and then randomization will be performed using blocks of 4. An independent person will maintain the confidentiality of the allocation list throughout the study, Blinding description: In this double-blind study , participants, caregivers, researchers, and data collectors will be blinded to the type of intervention and patient grouping. Patients are randomly assigned to receive either lidocaine or dexamethasone, the study drugs is prepared in 2 ml syringes of identical volume and appearance by a nurse who is not involved in the data collection process to ensure blinding and prevent disclosure of interventions. 3 Condition 1: Ocular pain. Condition 2: Nausea and vomiting. Condition 3: cough. Condition 4: Sore throat. Condition 5: Extubation time. Intervention 1: Intervention Group: IV Lidocaine, Drug: Lidocaine 2% (20 mg/mL), Dose and Calculation Method: 1.5 mg/kg of patient body weight, Dose Cap: The maximum allowable dose is 100 mg, Injection Volume: The final calculated volume will be drawn into identical, indistinguishable 10 mL syringes, Injection Time: The drug is injected as a slow IV bolus over 3-5 minutes, prior to extubation. Intervention 2: Control/Comparison Group: Intravenous Dexamethasone, Drug: Dexamethasone (4 mg/mL), Dose and Calculation Method: 0.1 mg/kg of patient body weight, Dose Cap: The maximum allowable dose is 8 mg, Injection Volume: The final calculated volume will be drawn into identical, indistinguishable 10 mL syringes (same as the lidocaine group), Injection Time: The drug is injected as a slow IV bolus over 3-5 minutes, immediately after induction of general anesthesia and before the start of surgery. Yes - There is a plan to make this available What will be shared: The participant data file, study protocol, clinical study report without individual patient data and statistical data will be published. When: The access period begins 6 months after publication of the article. To whom: Researchers from academic institutions will have access. Conditions: There are no special conditions. Where to obtain: Dr. Hamidreza Shatabi How to obtain: By email to the research manager: hamidshetabi@med.mui.ac.ir Comments:
public Hamidreza Shetabi
Faiz Hospital, Modares Street
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3668 8138 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidreza Shetabi
Faiz Hospital, Modares Street
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3668 8138 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age range between 60 and 80 years Candidate for eye surgeries under general anesthesia Patient's informed consent to participate in the study ASA Class I-II 60 years 80 years Both Having a history of allergies or known allergies to lidocaine, dexamethasone or other drugs used in the study protocol. Patients with a history of nausea and vomiting after surgery Taking strong painkillers (such as narcotics), anti-inflammatory drugs or corticosteroids or anti-nausea and vomiting before surgery. Existence of severe cognitive impairment (for example, advanced dementia), severe mental illness or lack of fluency in Persian, which makes it impossible to communicate and evaluate the criteria of outcomes (such as pain). Severe heart failure (less than 30% cardiac discharge fraction) Severe cardiac conduction disorders (such as second or third degree heart blocks) Severe liver failure (Cirrhosis of Child-P Class B or C) Severe renal failure (EGFR < 30 ml / min) Diseases neuromuscular (such as myasthenia gravis) H57.1 R11 R05 J02 Ocular pain Nausea and vomiting Cough Acute pharyngitis Treatment - Drugs Treatment - Drugs Intervention Group: IV Lidocaine, Drug: Lidocaine 2% (20 mg/mL), Dose and Calculation Method: 1.5 mg/kg of patient body weight, Dose Cap: The maximum allowable dose is 100 mg, Injection Volume: The final calculated volume will be drawn into identical, indistinguishable 10 mL syringes, Injection Time: The drug is injected as a slow IV bolus over 3-5 minutes, prior to extubation. Control/Comparison Group: Intravenous Dexamethasone, Drug: Dexamethasone (4 mg/mL), Dose and Calculation Method: 0.1 mg/kg of patient body weight, Dose Cap: The maximum allowable dose is 8 mg, Injection Volume: The final calculated volume will be drawn into identical, indistinguishable 10 mL syringes (same as the lidocaine group), Injection Time: The drug is injected as a slow IV bolus over 3-5 minutes, immediately after induction of general anesthesia and before the start of surgery. Extubation time. Timepoint: From the time the anesthetic agent (isoflurane) is discontinued until the moment the tracheal tube is removed (Extubation). Method of measurement: In minutes. Measurement method: Time recorded by stopwatch by a blinded assessor who was unaware of the patient's grouping. Postoperative Pain Intensity. Timepoint: Every 10 minutes during the patient's stay in recovery. Method of measurement: Using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (the most severe pain possible). Postoperative Nausea and Vomiting (PONV). Timepoint: Every 10 minutes during the patient's stay in recovery. Method of measurement: Observational recording by the recovery ward nurse (blinded) and direct questioning of the patient. Rescue analgesic use. Timepoint: Every 10 minutes during the patient's stay in recovery. Method of measurement: Direct questioning of the patient. Rescue antiemetic use. Timepoint: Every 10 minutes during the patient's stay in recovery. Method of measurement: Observing and questioning the patient. Length of stay in the recovery ward. Timepoint: Every 10 minutes during the patient's stay in recovery. Method of measurement: From the patient's entry into the recovery ward until they meet the criteria for discharge from recovery (Aldrete score ≥ 9). The patient's overall satisfaction with the quality of the recovery period after anesthesia. Timepoint: At the end of their recovery stay. Method of measurement: Using a Likert scale (from 1 "very dissatisfied" to 5 "very satisfied"). Drug-related side effects. Timepoint: Every 10 minutes during the patient's stay in recovery. Method of measurement: Observing and questioning the patient. Esfahan University of Medical Sciences Approved 2025-06-28 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Boulevard Isfahan Isfehan Iran (Islamic Republic of)