Comparison effect of Diphenhydramine-propofol versus ketamine-propofol in improving the quality of deep sedation in male patients undergoing rigid cystoscopy
Comparison of the effect of diphenhydramine-propofol and ketamine-propofol on sedation and analgesia for male cystoscopy
Design
A double-blind clinical trial study of 100 male patients who are candidates for cystoscopy at Sina Hospital in Tehran.
Settings and conduct
This double-blind and clinical trial will be conducted on 100 male patients who are candidates for cystoscopy at Sina Hospital in Tehran. The patients are divided into two groups by Block balanced randomization.This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind). Assessor and analyzer and participant are not aware of group allocation
Participants/Inclusion and exclusion criteria
Inclusion criteria:male patients, age 20 to 75 years old, ASA Class 1 and 2, cystoscopy candidate, 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 use of drug or alcohol ,no history of psychological illness Exclusion criteria:lack of consent
Intervention groups
Diphenhydramine and propofol group: 0.6 mg / kg diphenhydramine and 0.6 mg / kg propofol .Ketamine and propofol group: 0.5 mg / kg ketamine and 0.6 mg / kg propofol Receive.
Main outcome variables
Duration of cystoscopy - Pain intensity - Patient and surgeon satisfaction - Depth of sedation - Total propofol consumption changes in mean Arterial blood pressure -changes in Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N12
Registration date:2022-05-03, 1401/02/13
Registration timing:prospective
Last update:2022-05-03, 1401/02/13
Update count:0
Registration date
2022-05-03, 1401/02/13
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Diphenhydramine-propofol versus ketamine-propofol in improving the quality of deep sedation in male patients undergoing rigid cystoscopy
Public title
Comparison of the effect of diphenhydramine propofol with ketamine propofol on analgesia in male patients under cystoscopy
Purpose
Treatment
Inclusion/Exclusion 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:
History of closed glaucoma
History of dry mouth disease
Age
From 20 years old to 75 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sina hospital; Hasan Abad square; Emam khomeni street
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2022-05-02, 1401/02/12
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1401.014
Health conditions studied
1
Description of health condition studied
Cystoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of Cystoscopy
Timepoint
Once .Start and end of Cystoscopy
Method of measurement
With stopwatch
2
Description
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
3
Description
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
4
Description
The amount of propofol consumed
Timepoint
Once at the end of cystoscopy
Method of measurement
In milligrams
5
Description
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
6
Description
pain intensity
Timepoint
During cystoscopy and in recovery
Method of measurement
visual analog scale (VAS)
7
Description
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
8
Description
Quality and patient satisfaction from sedation
Timepoint
in recovery room
Method of measurement
Ask the patients and score from 1-4
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Reza Khajavi
Street address
Sina Hospital Imam khomeini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research,Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tehran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Main study outcome data
When the data will become available and for how long
Six months after the end of the study
To whom data/document is available
University researchers
Under which criteria data/document could be used
Share experiences to increase the knowledge
From where data/document is obtainable
khajavim@tums.ac.ir
Dr.khajavi
What processes are involved for a request to access data/document
Through Dr. Khajavi
e-mail address: khajavim@tums.ac.ir