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IRCT20260428069192N4 IRCT 2026-08-15 Tehran University of Medical Sciences Investigating the Effect of Propofol-Ketamine Combination on the Quality of Emergence from Anesthesia To compare the efficacy of propofol monotherapy versus propofol-ketamine combination on peri-extubation outcomes in patients undergoing laparoscopic cholecystectomy under general anesthesia 2026-07-14 anticipated 100 Recruiting https://irct.ir/trial/91987 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be divided into two equal groups using the simple randomization method. A random number sequence will be generated using statistical software (such as SPSS or Excel) via the random number function (RANDBETWEEN). Odd numbers will be allocated to Group 1 (Propofol alone) and even numbers to Group 2 (Propofol–Ketamine combination). The allocation sequence will be prepared by an independent colleague who is not involved in the data collection process. To ensure allocation concealment, the group codes will be placed in sequentially numbered, opaque, sealed envelopes. After obtaining written informed consent and upon the patient's arrival in the operating room, the corresponding envelope will be opened, and the assigned intervention will be administered, Blinding description: This study will be conducted as a double-blind trial. The study drugs for both groups will be prepared by an independent colleague who is not involved in data collection, and will be provided to the anesthesiologist in identical, coded containers. The anesthesiologist will be aware of the drug composition due to the clinical necessity of knowing the type and dosage of the administered agent for safe anesthesia management. However, the patient will remain unaware of the treatment allocation, and the data analyst, who is responsible for the statistical analysis of the results, will remain blinded to the group codes until the completion of all analyses. Thus, blinding of the patient and the data analyst is maintained. 3 Laryngeal spasm. Intervention 1: Intervention group: Premedication consists of midazolam 0.03–0.05 mg/kg IV (manufactured by Tehran Shimi Pharmaceutical Company, brand: Midazolam Tehran Shimi) and fentanyl 1–2 µg/kg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Fentanyl Exir), administered 5 minutes before induction at the discretion of the anesthesiologist. Anesthesia is induced with propofol 2 mg/kg IV (propofol 1%, injectable emulsion, manufactured by Tehran Shimi Pharmaceutical Company, brand: T-Cifol) given as a slow bolus over 30–60 seconds, along with ketamine 0.5 mg/kg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Ketamine Hydrochloride Exir) administered simultaneously (either in a single syringe or in two separate syringes via two different IV lines, according to the anesthesiologist's discretion). To facilitate tracheal intubation, atracurium 0.5 mg/kg IV (manufactured by Iran Hormone Pharmaceutical Company, brand: Atracurium Iran Hormone) is administered. Anesthesia is maintained with a continuous IV infusion of propofol at 100–150 µg/kg/min (via syringe pump). In this group, no additional ketamine is administered unless clinically necessary (e.g., severe hypotension or inadequate depth of anesthesia), in which case ketamine 0.25–0.5 mg/kg IV will be given as a bolus by the anesthesiologist. If needed, supplemental doses of atracurium (0.1 mg/kg) are given to maintain muscle relaxation. Mechanical ventilation is performed with an oxygen–air mixture (FiO₂=0.5) using a volume-controlled ventilator, adjusted to maintain EtCO₂ within 35–45 mmHg. Hemodynamic parameters (blood pressure, heart rate, oxygen saturation) are continuously monitored throughout surgery. A decrease in mean arterial pressure >20% from baseline is treated with intravenous fluids or ephedrine (manufactured by Tehran Shimi Pharmaceutical Company, brand: Ephedrine Tehran Shimi), and bradycardia with atropine (manufactured by Tehran Shimi Pharmaceutical Company, brand: Atropine Tehran Shimi). At the end of surgery, the propofol infusion is discontinued and the patient is transferred to the recovery room. If pain is present, morphine 0.05–0.1 mg/kg IV (manufactured by Darupakhsh Pharmaceutical Company, brand: Morphine Sulfate Darupakhsh) is administered; if nausea occurs, ondansetron 4 mg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Ondansetron Exir) is given. All drugs are administered by the anesthesiologist via the intravenous route according to the department's standard protocol. The intervention duration is calculated from induction until the end of surgery. Intervention 2: Control group: Premedication consists of midazolam 0.03–0.05 mg/kg IV (manufactured by Tehran Shimi Pharmaceutical Company, brand: Midazolam Tehran Shimi) and fentanyl 1–2 µg/kg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Fentanyl Exir), administered 5 minutes before induction at the discretion of the anesthesiologist. Anesthesia is induced with propofol 2 mg/kg IV (propofol 1%, injectable emulsion, manufactured by Tehran Shimi Pharmaceutical Company, brand: T-Cifol) given as a slow bolus over 30–60 seconds. To facilitate tracheal intubation, atracurium 0.5 mg/kg IV (manufactured by Iran Hormone Pharmaceutical Company, brand: Atracurium Iran Hormone) is administered. Anesthesia is maintained with a continuous IV infusion of propofol at 100–150 µg/kg/min (via syringe pump). If needed, supplemental doses of atracurium (0.1 mg/kg) are given to maintain muscle relaxation. Mechanical ventilation is performed with an oxygen–air mixture (FiO₂=0.5) using a volume-controlled ventilator, adjusted to maintain EtCO₂ within 35–45 mmHg. Hemodynamic parameters (blood pressure, heart rate, oxygen saturation) are continuously monitored throughout surgery. A decrease in mean arterial pressure >20% from baseline is treated with intravenous fluids or ephedrine (manufactured by Tehran Shimi Pharmaceutical Company, brand: Ephedrine Tehran Shimi), and bradycardia with atropine (manufactured by Tehran Shimi Pharmaceutical Company, brand: Atropine Tehran Shimi). At the end of surgery, the propofol infusion is discontinued and the patient is transferred to the recovery room. If pain is present, morphine 0.05–0.1 mg/kg IV (manufactured by Darupakhsh Pharmaceutical Company, brand: Morphine Sulfate Darupakhsh) is administered; if nausea occurs, ondansetron 4 mg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Ondansetron Exir) is given. All drugs are administered by the anesthesiologist via the intravenous route according to the department's standard protocol. The intervention duration is calculated from induction until the end of surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is decided that individual participant data will not be publicly shared, and only the results of aggregate analyses will be published in the final article. The main reason for this decision is to protect the confidentiality and privacy of the participants. It should be noted that the initial informed consent form did not include permission for the publication and sharing of personal data of the patients. However, upon formal request from the journal in which the article will be published, the raw data may be made available to the journal's reviewers or editors, after complete removal of all identifiable information (such as names, surnames, contact numbers, and any personal identifiers), and will only be presented with hospital codes that have been assigned to each patient from the beginning of the study. No public dissemination of personal data will take place.
public mohamad Sorani
No. 17, Bastani Parizi Alley, Ghods St., Enghelab Ave., Enghelab Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1417744361 +98 21 8898 3025 mohamad.sorani@gmail.com Tehran University of Medical Sciences scientific mohamad Sorani
No. 17, Bastani Parizi Alley, Ghods St., Enghelab Ave., Enghelab Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1417744361 +98 21 8898 3025 mohamad.sorani@gmail.com Tehran University of Medical Sciences Iraq Age: Adults aged 18 to 65 years. ASA Physical Status: Classified as American Society of Anesthesiologists (ASA) physical status I or II. Surgical Procedure: Scheduled for an elective laparoscopic or open cholecystectomy under general anesthesia. Consent: Willing and able to provide written informed consent after understanding the study protocol. 18 years 65 years Both Severe Underlying Diseases: Presence of severe cardiac, pulmonary, hepatic, renal, or neurological disorders. Drug Allergy: Documented hypersensitivity or contraindication to propofol or ketamine. Psychiatric History or Substance Abuse: A history of mental illness or substance abuse. Pregnancy and Lactation: Pregnant or lactating women. Morbid Obesity: Body mass index (BMI) exceeding 35 kg/m². Difficult Airway: Anticipated difficult airway based on standard pre-anesthetic assessments. Emergency Surgery: Requirement for urgent or emergency surgical intervention. J38.5 Laryngeal spasm Treatment - Drugs Treatment - Drugs Intervention group: Premedication consists of midazolam 0.03–0.05 mg/kg IV (manufactured by Tehran Shimi Pharmaceutical Company, brand: Midazolam Tehran Shimi) and fentanyl 1–2 µg/kg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Fentanyl Exir), administered 5 minutes before induction at the discretion of the anesthesiologist. Anesthesia is induced with propofol 2 mg/kg IV (propofol 1%, injectable emulsion, manufactured by Tehran Shimi Pharmaceutical Company, brand: T-Cifol) given as a slow bolus over 30–60 seconds, along with ketamine 0.5 mg/kg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Ketamine Hydrochloride Exir) administered simultaneously (either in a single syringe or in two separate syringes via two different IV lines, according to the anesthesiologist's discretion). To facilitate tracheal intubation, atracurium 0.5 mg/kg IV (manufactured by Iran Hormone Pharmaceutical Company, brand: Atracurium Iran Hormone) is administered. Anesthesia is maintained with a continuous IV infusion of propofol at 100–150 µg/kg/min (via syringe pump). In this group, no additional ketamine is administered unless clinically necessary (e.g., severe hypotension or inadequate depth of anesthesia), in which case ketamine 0.25–0.5 mg/kg IV will be given as a bolus by the anesthesiologist. If needed, supplemental doses of atracurium (0.1 mg/kg) are given to maintain muscle relaxation. Mechanical ventilation is performed with an oxygen–air mixture (FiO₂=0.5) using a volume-controlled ventilator, adjusted to maintain EtCO₂ within 35–45 mmHg. Hemodynamic parameters (blood pressure, heart rate, oxygen saturation) are continuously monitored throughout surgery. A decrease in mean arterial pressure >20% from baseline is treated with intravenous fluids or ephedrine (manufactured by Tehran Shimi Pharmaceutical Company, brand: Ephedrine Tehran Shimi), and bradycardia with atropine (manufactured by Tehran Shimi Pharmaceutical Company, brand: Atropine Tehran Shimi). At the end of surgery, the propofol infusion is discontinued and the patient is transferred to the recovery room. If pain is present, morphine 0.05–0.1 mg/kg IV (manufactured by Darupakhsh Pharmaceutical Company, brand: Morphine Sulfate Darupakhsh) is administered; if nausea occurs, ondansetron 4 mg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Ondansetron Exir) is given. All drugs are administered by the anesthesiologist via the intravenous route according to the department's standard protocol. The intervention duration is calculated from induction until the end of surgery Control group: Premedication consists of midazolam 0.03–0.05 mg/kg IV (manufactured by Tehran Shimi Pharmaceutical Company, brand: Midazolam Tehran Shimi) and fentanyl 1–2 µg/kg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Fentanyl Exir), administered 5 minutes before induction at the discretion of the anesthesiologist. Anesthesia is induced with propofol 2 mg/kg IV (propofol 1%, injectable emulsion, manufactured by Tehran Shimi Pharmaceutical Company, brand: T-Cifol) given as a slow bolus over 30–60 seconds. To facilitate tracheal intubation, atracurium 0.5 mg/kg IV (manufactured by Iran Hormone Pharmaceutical Company, brand: Atracurium Iran Hormone) is administered. Anesthesia is maintained with a continuous IV infusion of propofol at 100–150 µg/kg/min (via syringe pump). If needed, supplemental doses of atracurium (0.1 mg/kg) are given to maintain muscle relaxation. Mechanical ventilation is performed with an oxygen–air mixture (FiO₂=0.5) using a volume-controlled ventilator, adjusted to maintain EtCO₂ within 35–45 mmHg. Hemodynamic parameters (blood pressure, heart rate, oxygen saturation) are continuously monitored throughout surgery. A decrease in mean arterial pressure >20% from baseline is treated with intravenous fluids or ephedrine (manufactured by Tehran Shimi Pharmaceutical Company, brand: Ephedrine Tehran Shimi), and bradycardia with atropine (manufactured by Tehran Shimi Pharmaceutical Company, brand: Atropine Tehran Shimi). At the end of surgery, the propofol infusion is discontinued and the patient is transferred to the recovery room. If pain is present, morphine 0.05–0.1 mg/kg IV (manufactured by Darupakhsh Pharmaceutical Company, brand: Morphine Sulfate Darupakhsh) is administered; if nausea occurs, ondansetron 4 mg IV (manufactured by Exir Boroujerd Pharmaceutical Company, brand: Ondansetron Exir) is given. All drugs are administered by the anesthesiologist via the intravenous route according to the department's standard protocol. The intervention duration is calculated from induction until the end of surgery. Extubation quality score based on a validated 5-point scale comprising four domains: cough severity (none/mild/moderate/severe), agitation severity (none/mild/moderate/severe), breath-holding (present/absent), and laryngospasm (present/absent), assessed immediately after extubation. Timepoint: Measurement of the extubation quality score immediately after extubation. This assessment is performed at a single time point by the blinded outcome assessor. Method of measurement: Direct observation by a blinded assessor at the moment of extubation, using a validated 5-point scale (coughing, agitation, breath-holding, laryngospasm). Recorded in the Case Report Form. Hypotension during Extubating. Timepoint: Incidence of hypotension, defined as a decrease in systolic blood pressure below 90 mmHg or a drop of more than 20% from baseline requiring pharmacological intervention. Measured using an automated non-invasive blood pressure (NIBP) cuff at baseline, induction, intubation, intraoperatively, extubation, and recovery. Recorded in the Case Report Form (CRF). Method of measurement: Automated NIBP cuff at baseline, induction, intubation, intraoperatively, extubation, and recovery. Recorded in CRF. Continuous ECG monitoring at baseline, induction, intubation, intraoperatively, extubation, and recovery. Recorded in CRF. Timepoint: during extubating. Method of measurement: cardiac monitoring using hospital monitoring devices. Tehran University of Medical Sciences Approved 2026-07-14 Ethics Committee of the School of Public Health and Paramedical Sciences, Tehran University of Medic School of Public Health, Tehran University of Medical Sciences (TUMS), Poursina St., Qods (Ghods) St., Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)