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IRCT20120915010841N28 IRCT 2026-07-20 Hamedan University of Medical Sciences Post injection Propofol pain Comparative study of intravenous administration of low-dose Propofol with lidocaine on the reduction of local pain caused by intravenous injection of full-dose Propofol during induction of general anesthesia 2026-08-23 anticipated 88 Recruiting https://irct.ir/trial/90878 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, we will use the quadruple Block Randomization method. For this purpose, we prepare four sheets of paper.Write the letter A on two sheets and the letter B on the other two sheets. Mix the sheets together and place them in the desk drawer. With the referral of each eligible patient, one of the sheets is randomly taken out and based on this sheet is A or B, it will be assigned to one of the two groups of Propofol or Lidocaine. After randomly pulling out all four sheets, all the papers are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached, Blinding description: After inserting a size 20 angiocatheter into the patient's hand and receiving 5ml/kg of Ringer's solution, the patient's hand will be held up for 10 seconds, then the top of the angiocatheter will be blocked with a tourniquet, and on the randomization block, one of two drugs, Lidocaine (40 mg) or Propofol (20 mg), will be injected by the anesthesiologist. in syringes of the same shape and volume, covered with cloth tape, and numbered by the nurse anesthetist (who is unaware of the details of the design). 2-3 Pain reduction from intravenous injection of full dose of propofol. Intervention 1: Intervention group: After entering the operating room, a 20-gauge angiocatheter is first fixed in the veins on the back of the patient's hand. After receiving 5 ml/kg of Ringer's serum, the patient's hand is held up for 10 seconds and then the upper part of the angiocatheter is blocked with a tourniquet, and then lidocaine (40 mg) is injected by the anesthesiologist through the same angiocatheter. After 2 minutes, the vein is opened and ¼ of the induction dose of propofol (0.5 mg/kg) is injected by the anesthesiologist through the same vein. Then, the intensity of pain in the patient's hand during the injection of propofol is assessed based on the visual scale of pain(VAS) and recorded in a questionnaire. Then, anesthesia induction is completely performed by injecting 2 ug/kg of fentanyl and the remaining dose of propofol (1.5 mg/kg) and 0.5 mg/kg of atracurium, and after 3 minutes, intubation will be performed. Intervention 2: Intervention group: After entering the operating room, a 20-gauge angiocatheter is first fixed in the veins on the back of the patient's hand. After receiving 5 ml/kg of Ringer's serum, the patient's hand is held up for 10 seconds and then the upper part of the angiocatheter is blocked with a tourniquet, and then propofol (20 mg) is injected by the anesthesiologist through the same angiocatheter. After 2 minutes, the vein is opened and ¼ of the induction dose of propofol (0.5 mg/kg) is injected by the anesthesiologist through the same vein. Then, the intensity of pain in the patient's hand during the injection of propofol is assessed based on the visual scale of pain(VAS) and recorded in a questionnaire. Then, anesthesia induction is completely performed by injecting 2 ug/kg of fentanyl and the remaining dose of propofol (1.5 mg/kg) and atracurium 0.5 mg/kg, and intubation will be performed after 3 minutes. 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 Because the study is not finished yet.
public Nahid Manouchehrian
Besat Hospital, Modafeane salamat St, Beheshti Blvd,
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3264 0030 manuchehriann@gmail.com Hamedan University of Medical Sciences scientific Nahid Manouchehrian
Besat Hospital, Modafeane salamat St, Beheshti Blvd
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3264 0030 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients aged from 18 to 60 years old ASA class 1 and 2 Candidate for elective surgery under general anesthesia 18 years 60 years Both History of cardiovascular disease History of seizure Consumption history of narcotics, sedatives and anti anxiety drugs Previous allergy to egg and peanut Previous allergy to Propofol and lidocaine Infection or wound on dorsal of hand Y48.1 Drugs, medicaments and biological substances causing adverse effects in therapeutic use Treatment - Drugs Treatment - Drugs Intervention group: After entering the operating room, a 20-gauge angiocatheter is first fixed in the veins on the back of the patient's hand. After receiving 5 ml/kg of Ringer's serum, the patient's hand is held up for 10 seconds and then the upper part of the angiocatheter is blocked with a tourniquet, and then lidocaine (40 mg) is injected by the anesthesiologist through the same angiocatheter. After 2 minutes, the vein is opened and ¼ of the induction dose of propofol (0.5 mg/kg) is injected by the anesthesiologist through the same vein. Then, the intensity of pain in the patient's hand during the injection of propofol is assessed based on the visual scale of pain(VAS) and recorded in a questionnaire. Then, anesthesia induction is completely performed by injecting 2 ug/kg of fentanyl and the remaining dose of propofol (1.5 mg/kg) and 0.5 mg/kg of atracurium, and after 3 minutes, intubation will be performed. Intervention group: After entering the operating room, a 20-gauge angiocatheter is first fixed in the veins on the back of the patient's hand. After receiving 5 ml/kg of Ringer's serum, the patient's hand is held up for 10 seconds and then the upper part of the angiocatheter is blocked with a tourniquet, and then propofol (20 mg) is injected by the anesthesiologist through the same angiocatheter. After 2 minutes, the vein is opened and ¼ of the induction dose of propofol (0.5 mg/kg) is injected by the anesthesiologist through the same vein. Then, the intensity of pain in the patient's hand during the injection of propofol is assessed based on the visual scale of pain(VAS) and recorded in a questionnaire. Then, anesthesia induction is completely performed by injecting 2 ug/kg of fentanyl and the remaining dose of propofol (1.5 mg/kg) and atracurium 0.5 mg/kg, and intubation will be performed after 3 minutes. Local Pain Score. Timepoint: After injection of 1/4 of Propofol dose. Method of measurement: Visual analog scale. Systolic & Diastolic Blood Pressure. Timepoint: Before and after injection of 1/4 dose of propofol, After injection of full dose of propofol and before & after intubation. Method of measurement: Automatic non-invasive blood pressure monitor. Mean Arterial Pressure. Timepoint: Before and after injection of 1/4 dose of propofol, After injection of full dose of propofol and before & after intubation. Method of measurement: Automatic non-invasive blood pressure monitor. Heart rate. Timepoint: Before and after injection of 1/4 dose of propofol, After injection of full dose of propofol and before & after intubation. Method of measurement: Pulse Oximetry. Amount of ephedrine and atropine used. Timepoint: During the operation. Method of measurement: Milligram. Hamedan University of Medical Sciences Approved 2026-04-25 Ethics committee of Hamadan University of Medical Sciences Mahdieh Street, Hamadan University of Medical Sciences Hamadan Hamadan Iran (Islamic Republic of)