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IRCT20251005067513N1 IRCT 2026-05-16 Shahre-kord University of Medical Sciences The effect of simultaneous injection of propofol and epinephrine in anesthesia. The effect of combined low-dose Epinephrine and Propofol infusion on Hemodynamic statues and Anesthesia-related complication: A Randomized Clinical Trial 2026-03-21 anticipated 60 Recruiting https://irct.ir/trial/87410 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining the researcher's consent, subjects will be randomly assigned to one of the two intervention and control groups using the Random Allocation software using permutation block allocation. For this purpose, 10 blocks of size 6 will be prepared and provided to an outsider to assign patients to the groups, Blinding description: An independent statistician generated the randomized sequence using variable blocks and placed it in opaque, sequentially numbered envelopes. A research assistant (who had no role in patient care) prepared identical syringes containing either 50 μg of epinephrine or normal saline, labeled only with the patient's code. Patients, the anesthesiologist, the surgeon, operating room personnel, the outcome assessor, and the data analyst were all blinded to group allocation until the analysis was completed. The study drug was administered by the research assistant through a separate port so that the treatment team could not see the syringe contents. No blinding violation occurred. All patients provided written informed consent to participate in the study. 3 Anesthesia. Intervention 1: Intervention group: General anesthesia with epinephrine: After induction of anesthesia by the anesthesiologist, a 1:10,000 dilution of epinephrine at a dose of 50 micrograms will be injected by the surgeon. Epinephrine will be injected after all anesthesia judges have been injected during induction of anesthesia. Intervention 2: Control group: Participants in this group will receive an equal volume (0.5 mL) of 0.9% normal saline (0.9% sodium chloride solution) as placebo. This placebo will be prepared by the research assistant in an identical syringe with exactly the same appearance as the epinephrine syringe (colorless and clear solution). It will be administered immediately after completion of anesthesia induction (midazolam, fentanyl, propofol, and cisatracurium) via a separate intravenous port as a rapid intravenous bolus over 5–10 seconds. The timing of injection, injection site (the arm opposite to the anesthesia drug infusion line), and injection speed are identical in both groups. Participants, the treatment team (anesthesiologist, surgeon, nurse), and the outcome assessor are blinded to the type of injected solution. No additional additives or preservatives are present in the placebo syringe. 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 No further information available.
public Mohammad javad Torkan
Isfahan City, Sepahanshahr Town, Shahed Boulevard, Alvand4 Street, Farhang Alley, Aria Alley, No. 6,
Isfehan Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 31 3651 9630 drmjt1372@gmail.com Shahre-kord University of Medical Sciences scientific Mohammad javad Torkan
Isfahan City, Sepahanshahr Town, Shahed Boulevard, Alvand4 Street, Farhang Alley, Aria Alley, No. 6,
Isfehan Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 31 3651 9630 drmjt1372@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) 1. Age 18 to 45 years 2. ASA class I and II (except for hypertension and cardiac disease) 3. Written consent to participate in the study 18 years 45 years Both People with coagulation disorders, heart disease, hypertension, cerebrovascular disease, peripheral vascular disease, or drug allergies Patient unwillingness to continue participation in the study or failure to sign the informed consent form. Alcohol and caffeine consumption Detection of any severe hemodynamic instability or unexpected need for emergency intervention during initial monitoring/assessment. Unexpected findings on baseline laboratory tests (if performed) that constitute a contraindication to the intervention. Inability to ensure standard conditions for baseline measurements (e.g., severe uncooperativeness). Treatment - Drugs Treatment - Drugs Intervention group: General anesthesia with epinephrine: After induction of anesthesia by the anesthesiologist, a 1:10,000 dilution of epinephrine at a dose of 50 micrograms will be injected by the surgeon. Epinephrine will be injected after all anesthesia judges have been injected during induction of anesthesia. Control group: Participants in this group will receive an equal volume (0.5 mL) of 0.9% normal saline (0.9% sodium chloride solution) as placebo. This placebo will be prepared by the research assistant in an identical syringe with exactly the same appearance as the epinephrine syringe (colorless and clear solution). It will be administered immediately after completion of anesthesia induction (midazolam, fentanyl, propofol, and cisatracurium) via a separate intravenous port as a rapid intravenous bolus over 5–10 seconds. The timing of injection, injection site (the arm opposite to the anesthesia drug infusion line), and injection speed are identical in both groups. Participants, the treatment team (anesthesiologist, surgeon, nurse), and the outcome assessor are blinded to the type of injected solution. No additional additives or preservatives are present in the placebo syringe. Mean heart rate (beats per minute) at four time points: before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), and at the end of surgery (T3). Timepoint: Before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), and at the end of surgery (T3). Method of measurement: Same pulse oximetry. Determining and comparing the mean blood pressure score of patients undergoing surgery under general anesthesia with propofol before, immediately, and after the intervention in the two intervention and control groups, within and between groups. Timepoint: Before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), end of surgery (T3). Method of measurement: Cuffs of the same size arm in the same place for the same people. Mean arterial oxygen saturation percentage (SpO₂) at four time points: before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), and at the end of surgery (T3). Timepoint: Before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), end of surgery (T3). Method of measurement: Same Pulse oximetry. Mean respiratory rate (breaths per minute) at four time points: before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), and at the end of surgery (T3). Timepoint: Before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), end of surgery (T3). Method of measurement: Counting the number of breaths per minute. Occurrence of any electrocardiogram rhythm or morphology changes including ventricular tachycardia, bradycardia requiring treatment, ventricular or atrial extrasystoles, and ST segment changes during anesthesia until the end of recovery. Timepoint: Continuously from before induction (T0) until the end of recovery (up to 2 hours after surgery), recording any clinically significant change. Method of measurement: ECG. Frequency of the following adverse events within 30 minutes after arrival in the post‑anesthesia care unit: nausea, vomiting, post‑anesthetic shivering, arrhythmia diagnosed by electrocardiogram, and severe pain (visual analogue scale score ≥ 7). Timepoint: Continuously during the first 30 minutes after transfer to the recovery room; pain assessment at arrival and at 30 minutes. Method of measurement: Follow up. Mean diastolic blood pressure (mmHg) at four time points: before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), and at the end of surgery (T3). Timepoint: Before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), end of surgery (T3). Method of measurement: Cuffs of the same size arm in the same place for the same people. Mean arterial pressure (mmHg) at four time points: before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), and at the end of surgery (T3). Timepoint: Before induction (T0), one minute post-induction (T1), three minutes post-induction (T2), end of surgery (T3). Method of measurement: Cuffs of the same size arm in the same place for the same people (1/3 SBP* 2/3 DBP). Shahre-kord University of Medical Sciences Approved 2025-09-28 Ethics Committee of Shahrekord University of Medical Sciences Shahrekord University of Medical Sciences, Kashani Street, Shahrekord town Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)