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IRCT20130304012695N12 IRCT 2022-05-03 Deputy of Research,Tehran University of Medical Sciences Comparison of the effect of diphenhydramine propofol with ketamine propofol on analgesia in male patients under cystoscopy Comparison effect of Diphenhydramine-propofol versus ketamine-propofol in improving the quality of deep sedation in male patients undergoing rigid cystoscopy 2022-05-21 anticipated 100 Complete https://irct.ir/trial/63295 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize patients with inclusion criteria Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group. The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room, Blinding description: To randomize patients with inclusion criteria Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group. The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room. 2-3 Cystoscopy. Intervention 1: Intervention group: First, midazolam was injected 0.03 mg / kg, fentanyl 2µ /kg intravenously, then patients in the Diphenhydramine group received 0.6 mg / kg diphenhydramine intravenously. Propofol 0.5 mg / kg is injected 3 minutes after injection of these drugs and 60 seconds before the start of cystoscopy. Then the quality of sedation, pain and hemodynamic changes are examined during cystoscopy. In case of pain and movements that indicate the patient's intolerance, propofol is injected again to calm the patient. Intervention 2: Control group: First, midazolam was injected 0.03 mg / kg, fentanyl 2µ /kg intravenously, then patients in the Ketamine group received 0.6 mg / kg ketamine intravenously. Propofol 0.5 mg / kg is injected 3 minutes after injection of these drugs and 60 seconds before the start of cystoscopy. Then the quality of sedation, pain and hemodynamic changes are examined during cystoscopy. In case of pain and movements that indicate the patient's intolerance, propofol is injected again to calm the patient. Yes - There is a plan to make this available What will be shared: Main study outcome data When: Six months after the end of the study To whom: University researchers Conditions: Share experiences to increase the knowledge Where to obtain: khajavim@tums.ac.ir Dr.khajavi How to obtain: Through Dr. Khajavi e-mail address: khajavim@tums.ac.ir Comments:
public Mohammad Reza Khajavi
Imam khomeni St, Hasan Abad Sq, Sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 khajavim@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Reza Khajavi
Imam khomeni St, Hasan Abad Sq, Sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 khajavim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) male patient Age 20 to 75 years old Cystoscopy candidate ASA Class 1 and 2 No allergy to used drugs No history of cardio-pulmonary-liver and kidney disease Lack of Obstructive Sleep Apnea (OSA) No history of drug addiction or other psychotropic substances No history of acute drug or alcohol poisoning No history of psychological illness 20 years 75 years Male History of closed glaucoma History of dry mouth disease Treatment - Drugs Treatment - Drugs Intervention group: First, midazolam was injected 0.03 mg / kg, fentanyl 2µ /kg intravenously, then patients in the Diphenhydramine group received 0.6 mg / kg diphenhydramine intravenously. Propofol 0.5 mg / kg is injected 3 minutes after injection of these drugs and 60 seconds before the start of cystoscopy. Then the quality of sedation, pain and hemodynamic changes are examined during cystoscopy. In case of pain and movements that indicate the patient's intolerance, propofol is injected again to calm the patient. Control group: First, midazolam was injected 0.03 mg / kg, fentanyl 2µ /kg intravenously, then patients in the Ketamine group received 0.6 mg / kg ketamine intravenously. Propofol 0.5 mg / kg is injected 3 minutes after injection of these drugs and 60 seconds before the start of cystoscopy. Then the quality of sedation, pain and hemodynamic changes are examined during cystoscopy. In case of pain and movements that indicate the patient's intolerance, propofol is injected again to calm the patient. Duration of Cystoscopy. Timepoint: Once .Start and end of Cystoscopy. Method of measurement: With stopwatch. Mean Arterial Blood Pressure. Timepoint: Before the cystoscope enters the urethra and bladder, 30 seconds after entering the urethra, then every 2 minutes. Method of measurement: Non-invasive and automatically. Heart Rate. Timepoint: Before the cystoscope enters the urethra and bladder, 30 seconds after entering the urethra, then every 2 minutes. Method of measurement: from monitor. The amount of propofol consumed. Timepoint: Once at the end of cystoscopy. Method of measurement: In milligrams. Patient response when a cystoscope enters the urethra. Timepoint: When the cystoscope enters the urethra. Method of measurement: Observe the patient's movements and rate it from 0-3 according to the type of movements. Pain intensity. Timepoint: During cystoscopy and in recovery. Method of measurement: visual analog scale (VAS). Quality and satisfaction of the surgeon from Sedition. Timepoint: At the end of cystoscopy. Method of measurement: Ask the surgeon and score from 1-4. Quality and patient satisfaction from sedation. Timepoint: in recovery room. Method of measurement: Ask the patients and score from 1-4. Deputy of Research,Tehran University of Medical Sciences Approved 2022-05-02 Ethics committee of Tehran University of Medical Sciences Sina hospital; Hasan Abad square; Emam khomeni street Tehran Tehran Iran (Islamic Republic of)