Determining and comparing the effect of intravenous vitamin C with preoperative dextromethorphan syrup on pain after abdominal surgery
Design
The type of study:
Double-blind
Research community:
Abdominal surgery candidate patients referred to Tehran Islamic Azad University hospitals
Example of research:
Abdominal surgery candidate patients referred to Islamic Azad University hospitals, Tehran Medical Unit in 2021
Sample size:
75
Settings and conduct
This research is carried out in hospitals affiliated to Islamic Azad University, Tehran Medical Sciences Unit. After obtaining written consent from patients who are candidates for elective abdominal surgery, first a list of patients who are willing to participate in the research is prepared and after matching, each patient is assigned a number and randomly according to the table of random numbers. Online are placed in two groups.
(In order to make double-blind, the drugs at the beginning of the study are A/B by the nurse of the surgery department so that the researcher and the participants do not know the type of drug received). We put patients 2 and 1 in two groups A (recipient of vitamin C intravenously) and B (recipient of dextromethorphan syrup). Medicines are prescribed to patients upon entering the operating room and in the recovery room.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1. Sign the written informed consent form
2. Non-use of drugs and alcohol
3. Elective surgery
Exclusion criteria:
1. Loss of consciousness
2. Hemodynamic disorder
3. Abnormal intraoperative bleeding
4. The duration of the operation is more than 4 hours
Intervention groups
The effect of intravenous vitamin C with dextromethorphan syrup before abdominal surgery on postoperative pain
Main outcome variables
Abdominal post operative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230612058463N1
Registration date:2023-07-09, 1402/04/18
Registration timing:retrospective
Last update:2023-07-09, 1402/04/18
Update count:0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Parviz Foroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8844 1638
Email address
parvizforooghy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
2023-04-04, 1402/01/15
Actual recruitment end date
2023-07-01, 1402/04/10
Trial completion date
2023-07-01, 1402/04/10
Scientific title
Comparison The effect of intravenous vitamin C with dextromethorphan syrup before abdominal surgery on postoperative pain
Public title
Effect of dextromethorphan and vit c in postoperative pain in abdominal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with elective abdominal surgery
Non-use of drugs and alcohol
Sign the written informed consent form
Exclusion criteria:
Decrease level of consciousness
Unstable hemodynamic
Abnormal intraoperative bleeding
Length of operation more than 4 hours
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
150
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines are given to patients without knowing the type of syrup or the type of ampoule. The nurse knows about the prescribed medicine, but the researcher does not.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences
Street address
Islamic Azad University of Medical Sciences, Shariati St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.IAU.TMU.REC.1401.315
Health conditions studied
1
Description of health condition studied
Abdominal post operative pain
ICD-10 code
R10.8
ICD-10 code description
Other abdominal pain
Primary outcomes
1
Description
Pain
Timepoint
The amount of pain in the first hour, 6, 12, 24, after the operation
Method of measurement
Visual analog scales: The visual scale for measuring pain intensity is a 10 cm ruler, with the word "no pain" written at the left end and the most severe state of pain at the right end.This questionnaire has been confirmed in terms of validity and reliability
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving dextromethorphan syrup, each 5 cc of which contains 15 mg of dextromethorphan in the amount of 15 cc in patients under 60 kg and 30 cc in patients over 30 kg by spoon orally before It is consumed from entering the operating room.
Category
Treatment - Drugs
2
Description
Control group: patients receiving 300 mg of injectable vitamin C drug in 200 cc volume of normal saline and administered intravenously to the patient before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali hospital
Full name of responsible person
Alireza Teimouri
Street address
Damavand Ave., Imam Hosien square, Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Fax
+98 21 3378 6182
Email
booali.hospital96@gmail.com
Web page address
https://tms.iau.ir/bouali/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Khoshdel
Street address
Islamic Azad University of Medical Sciences, Shariati St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Parviz Foroughi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 13, Taghavi Ave., north Sohrevardi Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1568636816
Phone
+98 21 8844 1638
Email
parvizforooghy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parviz Foroughi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 13, Taghavi Ave., north Sohrevardi Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1568636816
Phone
+98 21 8844 1638
Email
parvizforooghy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parviz Foroughi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 13, Taghavi Ave., north Sohrevardi Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1568636816
Phone
+98 21 8844 1638
Email
parvizforooghy@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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Full text of thesis
When the data will become available and for how long
2023
To whom data/document is available
Physicians and medical students
Under which criteria data/document could be used
Research
From where data/document is obtainable
parvizforooghy@gmail.com
What processes are involved for a request to access data/document