Determining the prophylactic effect of diphenhydramine with paracetamol on agitation and pain after laparoscopic cholecystectomy
Design
60 patients in the age group of 20 to 60 years with ASA class one and two will undergo laparoscopic cholecystectomy with selective general anesthesia.
Settings and conduct
Patients aged 20 to 60 years with ASA class one and two undergoing laparoscopic cholecystectomy with selective general anesthesia referred to Imam Khomeini Hospital in Urmia the night before surgery will receive 5 mg of diazepam oral drug. And on the day of operation will be randomly divided into two groups. In group (P), paracetamol will be injected simultaneously for more than 15 minutes (1 g of paracetamol per 100 ml of 0.9% NaCl) 10 minutes after induction of anesthesia. became. In the DP group, diphenhydramine 0.4 mg / kg intravenously in 100 ml of 0.9% Nacl with paracetamol will be injected together for 10 minutes after induction of anesthesia.
Participants/Inclusion and exclusion criteria
The age group of 20 to 60 years with ASA class one and two will undergo laparoscopic cholecystectomy with elective general anesthesia. Patients with hypertension, history of heart disease, gastritis, kidney and lung disease, stomach pain, mental health problems and drug addicts and people treated with beta-blockers, methyl dopa, monoamine oxidase inhibitors, analgesics, BMI Above 30 will be excluded from the study
Intervention groups
Intravenous paracetamol group and diphenhydramine group
Main outcome variables
Pain / agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170411033365N4
Registration date:2022-07-20, 1401/04/29
Registration timing:prospective
Last update:2022-07-20, 1401/04/29
Update count:0
Registration date
2022-07-20, 1401/04/29
Registrant information
Name
Alireza Mahoori
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 8967
Email address
mahouri.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-22, 1401/05/31
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the prophylactic combined effect of diphenhydramine with paracetamol on agitation and pain after laparoscopic cholecystectomy
Public title
Assessment of the prophylactic combined effect of diphenhydramine with paracetamol on agitation and pain after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 20 to 60 years
Patients with ASA class one and two undergo laparoscopic cholecystectomy
Selective general anesthesia
Exclusion criteria:
Patients aged 20 to 60 years with ASA class one and two undergoing laparoscopic cholecystectomy
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The number of patients in this study will be 60 patients. Patients will be randomly divided into two equal groups by computer numbers via a certified true randomizer number generator (www.random.org,
Android Play Store) and Based on the last number of the file number .From number of 0-30 in control group and 31-60 will be placed in Diphenhydramine and Paracetamol group. Target codes will be written and placed in sealed envelops with sequential allocation using single blind method.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the clinical caregiver and outcome assessor will be unaware of which group each patient belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Determining the prophylactic effect of diphenhydramine with paracetamol on agitation and pain after laparoscopic cholecystectomy
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.UMSU.REC.1401.078
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Agitation and pain
Timepoint
In recovery and after transfer to the ward at 6, 12 and 24 hours after surgery
Method of measurement
The amount of visual scoring pain (VAS) from zero to 10 points and the amount of agitation at the time of recovery after 10, 20, 30 minutes after recovery, by four-point scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group (P), intravenous paracetamol will be injected simultaneously for more than 15 minutes (1 g of paracetamol per 100 ml of 0.9% NaCl) 10 minutes after induction of anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group: In the DP group, diphenhydramine 0.4 mg / kg intravenously in 100 ml of 0.9% Nacl with paracetamol will be injected together for 10 minutes after induction of anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Urmia
Full name of responsible person
Dr. Alireza Mahouri
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Fax
+98 44 3345 7277
Email
Mahouri.a@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Resalat Boulevard - Emergency Alley - Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5718748983
Phone
+98 44 3237 5907
Email
sabergholizadeh@yahoo.com
Web page address
https://Umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Alireza Mahouri
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
Mahouri.a@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Alireza Mahouri
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
Mahouri.a@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Alireza Mahour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia-IRAN
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
Mahouri.a@umsu.ac.ir
Web page address
http://Imam.umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available