Evaluation of the effect of dextromethorphan gargling on postoperative quality of recovery and analgesia after endo ultrasonography procedure in scopy ward
Evaluation of the effect of dextromethorphan gargling on postoperative quality of recovery and analgesia after endo ultrasonography procedure in scopy ward
Design
Clinical trial with control group, single-blind, randomized, phase 2 on 60 patients. Randomizer softwere was used for randomization.
Settings and conduct
Candidate patients for endosonography admitted to the scopy ward of Imam Reza Hospital are included in the study and are divided into two groups. The first group gargle dextromethorphan, the second group are sprayed lidocaine into their throats. The researcher and statistical analyzer did not notice the study groups. Finally, the information is evaluated for improvement in recovery and reduction of pain.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for endosonography, age 188 to 65 years, ASA groups 1 and 2
Exclusion criteria: Cardiovascular disease, history of depression, pregnant women
Intervention groups
Patients are divided into two groups. The first group gargle dextromethorphan, the second group are sprayed lidocaine into their throats.
Main outcome variables
Recovery quality; Pain reduce
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200612047740N5
Registration date:2022-06-23, 1401/04/02
Registration timing:prospective
Last update:2022-06-23, 1401/04/02
Update count:0
Registration date
2022-06-23, 1401/04/02
Registrant information
Name
Hossein Naderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3568 5233
Email address
hossein.naderi1374@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-22, 1401/04/31
Expected recruitment end date
2022-11-20, 1401/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dextromethorphan gargling on postoperative quality of recovery and analgesia after endo ultrasonography procedure in scopy ward
Public title
The effect of dextromethorphan gargling on improving the quality of recovery after endosonography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for endosonography
ASA 1 AND 2
Age 18 to 65 years
Exclusion criteria:
Cardiovascular disease
History of depression
Pregnant women
Addiction
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to the groups of A and B using Randomization software (https://www.randomizer.org/) according to inclusion criteria. Each group has 30 members. In this software, numbers from 1 to 60 are entered into the software and at one time, they randomly pick the numbers from 1 to 60 so that the number of people in each group is equal. The numbers remain hidden and the order in which people enter the study is revealed in the order in which the data output software is displayed, and if the number is between 1 and 30, it is placed in the first group and if it is between 31 and 60, it is placed in the second group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are divided into two groups A and B and are kept in two separate parts. How to do the study for each group is described. The information is collected by the clinical caregiver and the researcher and data analyzer do not know the patient group and after analyzing the data, the codes are decoded to avoid bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical
Street address
AJA university of medical sciences, Shahid Etemadzade st, West Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2022-06-19, 1401/03/29
Ethics committee reference number
IR.AJAUMS.REC.1401.020
Health conditions studied
1
Description of health condition studied
Pain after endosonography
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Severity of sore throat
Timepoint
After transfer to recovery
Method of measurement
visual analogue scale
2
Description
Satisfaction of operation
Timepoint
After transfer to recovery
Method of measurement
Numeric Pain Rating Scale
3
Description
Pain free period
Timepoint
From the time a person enters recovery to the time they feel pain in the throat
Method of measurement
Ask and record
Secondary outcomes
1
Description
Frequency of nausea and vomiting
Timepoint
After transfer to recovery
Method of measurement
View and record
2
Description
Frequency of cough
Timepoint
After transfer to recovery
Method of measurement
View and record
Intervention groups
1
Description
Intervention group: Patients gargle dextromethorphan for one minute before endosonography and endosonography is performed for them. After finishing the work and transferring them to recovery, the quality of recovery and the amount of sore throat are evaluated.
Category
Prevention
2
Description
Control group: Patients are sprayed 3 puffs of lidocaine on the back of their throats before endoscopy , then endosonography is performed for them. After finishing the work and transferring them to recovery, the quality of recovery and the amount of sore throat are evaluated.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mohammadreza Rafiee
Street address
Shahid Etemadzade st, West Fatemi
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
hossein.naderi1374@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Mojtaba Yousefi
Street address
Shahid Etemadzade st, West Fatemi st
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
research@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Naderi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University Of Medical Sciences., Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
7786114396
Phone
+98 31 3568 5233
Fax
Email
hossein.naderi1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Naderi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University Of Medical Sciences., Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
7786114396
Phone
+98 31 3568 5233
Fax
Email
hossein.naderi1374@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Naderi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University Of Medical Sciences., Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
7786114396
Phone
+98 31 3568 5233
Fax
Email
hossein.naderi1374@gmail.com
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
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only registered symptoms can be published without mentioning the names of the participants
When the data will become available and for how long
Start of access period 6 months after printing the results up to one year after printing
To whom data/document is available
Only available to scholars working in academia and academia
Under which criteria data/document could be used
Written request via email(hossein.naderi1374@gmail.com) and university approval
From where data/document is obtainable
By contacting the corresponding author
What processes are involved for a request to access data/document
After the email is received by the applicant, it takes one week to agree The university will be obtained and then will be notified to the requestor. Maximum of this process takes ten days.