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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130304012695N12
Enrollment
100
Registered
2022-05-03
Start date
2022-05-21
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystoscopy.

Interventions

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 intraven

Sponsors

Deputy of Research,Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: History of closed glaucoma History of dry mouth disease

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Khajavi

Tehran University of Medical Sciences

khajavim@tums.ac.ir+98 21 6312 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026