Evaluation of the preventive effect of intravenous diphenhydramine injection before induction of anesthesia on control of the catheter bladder discomfort after Nephrolithiasis surgery
Reduce pain and catheter bladder discomfort in patients after surgery and increase their cooperation in recovery and ward
Design
Clinical trial with control group, parallel groups, double-blind, randomized, phase 2 on 70 patients.The software rand function was used to randomize.
Settings and conduct
patients who are candidates for PCNL surgery in Sina hospital in the operating room with the Computer Generated Table technique are divided into two groups: Diphenhydramine (D) and Placebo (P). Before induction of anesthesia Diphenhydramine 0.6 mg / kg (maximum 50 mg) diluted in 5cc syringe (1cc = 10mg) is injected intravenously (IV) and in the placebo group, the same volume of 5 cc normal saline is injected.Anesthesia is the same in both groups Before incision , all patients receive 0.1 mg / kg morphine sulfate slowly intravenously within two minutes. The degree of sedation based on the Ramsy sedation scale, hemodynamic changes during extubation, severity of pain based on (vissule analog scale) and the incidence and severity of bladder discomfort will be evaluated in recovery . The need for analgesia in recovery and 24 hours after surgery is also assessed and recorded. Paracetamol is used for postoperative analgesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients candidate for per cutaneous nephrolithotomy (PCNL)
Exclusion criteria: Glucome, benign prostate hypertrophy, opioids addiction
Intervention groups
Intervention group: 50 mg of diphenhydramine is injected intravenously before anesthesia and the degree of agitation, pain during extubation and feeling of urination and severity of catheter bladder discomfort in recovery and ward will be evaluated
Control group: They do not receive medication
Main outcome variables
Incidence and severity of catheter bladder discomfort
degree of sedation
thermodynamics changes
analgesic requirement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N7
Registration date:2020-07-21, 1399/04/31
Registration timing:registered_while_recruiting
Last update:2020-07-21, 1399/04/31
Update count:0
Registration date
2020-07-21, 1399/04/31
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
2019-08-23, 1398/06/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the preventive effect of intravenous diphenhydramine injection before induction of anesthesia on control of the catheter bladder discomfort after Nephrolithiasis surgery
Public title
control catheter bladder discomfort
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All candidate candidate patients for Nephrolithiasis surgery
Exclusion criteria:
history of large prostate disease
Glucome
Drug addiction
uncontrolled hypertension
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
76
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
Participants.
Those who evaluate the outcome.
Data collection officials.
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, Imam Khomeini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.286
Health conditions studied
1
Description of health condition studied
catheter bladder discomfort
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Incidence and severity of catheter bladder discomfort
Timepoint
During extubation and 5, 15, 30 and 60 minutes after surgery
Method of measurement
Visual Analogue Scale
2
Description
Severity of postoperative agitation
Timepoint
During extubation and 5, 15, 30 and 60 minutes after surgery
Method of measurement
Ramsy sedation Scale
3
Description
Analgesic requirement in recovery and ward
Timepoint
During recovery period and first 24 hours after surgery
Method of measurement
The total amount of mg of morphine consumed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 mg of diphenhydramine is injected intravenously before anesthesia and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence and severity of catheter bladder discomfort in the recovery and the total amount of analgesic reqiurement are evaluated during 24 hours after surgery.
Category
Prevention
2
Description
Control group: They do not receive medication and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence and severity of catheter bladder discomfort in the recovery and the total amount of analgesic reqiurement are evaluated during 24 hours after surgery.
Category
Prevention
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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Keshavarz Blvd., corner of Quds St., Central Organizatioehran University of Medical Sciencesn of T
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
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
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Mohammadreza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8551
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
All information used for this research can be shared after unidentified the identity of patients. Also, statistical information, information analysis, study method, findings and conclusions can be shared.
When the data will become available and for how long
Starting access after accepting by a valid scientific journal and publishing it
To whom data/document is available
For academic researchers and in the field of science
Under which criteria data/document could be used
All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned.
From where data/document is obtainable
Mohammad Reza Khajavi
khajavim@tums.ac.ir
What processes are involved for a request to access data/document
The applicant can request the type of files by email.