Protocol summary

Study aim
Comparison of the effect of perioperative intravenous ketamine with fentanyl in control of acute pain after inguinal hernia repair surgery
Design
A randomized, double-blind clinical trial with a parallel groups design; phase 1-2; on 60 patients; divided into two groups of ketamine and fentanyl (control) by random software allocation.
Settings and conduct
This study will be conducted in urmia Imam Khomeini Medical Center. After entering the study, the participants will be randomly assigned to one of two ketamine and fentanyl (control) groups with 30 participants in each group. The patients and the nurse who will take care of them during the procedure will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 30-60 aged adults with inguinal hernia, Absence of contraindications for ketamine and opioids use, patients with American Society of Anesthesiologist (ASA) physical status I,II Exclusion criteria: History of allergic reactions to the drug under study, History of underlying diseases (diabetes, peptic ulcer, gastritis, coronary artery disease, renal failure), Any known psychiatric disorder, Patients with incarcerated hernia, patients with severe infection
Intervention groups
Intervention group: In ketamine group, Induction of anesthesia is done with 1 to 4 mg/kg of intravenous ketamine, and then in maintenance phase, intravenous perfusion of ketamine at a rate of 2 to 10 μg/kg/min will be prescribed. Control group: In fentanyl group, induction of anesthesia is performed with 1-2 μg/kg fentanyl as a routine anesthetic drug, and then maintenance phase, continuous infusion of fentanyl at a rate of 1-2 μg/kg/hr will be prescribed.
Main outcome variables
Postoperative pain measurement at 60, 90 minutes and 24 hours after surgery with numeric rating (NRS) scale from 0 to 10

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221126056613N5
Registration date: 2023-08-27, 1402/06/05
Registration timing: registered_while_recruiting

Last update: 2023-08-27, 1402/06/05
Update count: 0
Registration date
2023-08-27, 1402/06/05
Registrant information
Name
aliakbar nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
nasiriali7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of perioperative intravenous ketamine with fentanyl in control of acute pain after inguinal hernia repair surgery
Public title
Comparison of the effect of ketamine with fentanyl in control of acute pain after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30-60 aged adults with inguinal hernia Absence of contraindications for ketamine and opioids use patients with American Society of Anesthesiologist (ASA) physical status I,II
Exclusion criteria:
History of allergic reactions to the drug under study History of underlying diseases (diabetes, peptic ulcer, gastritis, coronary artery disease, renal failure) Any known psychiatric disorder Patients with incarcerated hernia patients with severe infection
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to two ketamine and fentanyl (control) groups using Random Allocation computer software. In this way, numbers are given to the patients according to the determined sample volume, and then the software allocates the patients to two ketamine and fentanyl (control) groups based on the given numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
After introducing the study to the patients and explaining the benefits and harms of the possible intervention, written consent is obtained from the patients. Then the patients are randomly assigned to one of the intervention or control groups. Patients and nurses who take care of the patients during the trial are blinded to the intervention and control groups, so that none of the nurses and patients know which drug, ketamine or fentanyl, the patients have been under general anesthesia with.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of urmia University of Medical Sciences
Street address
West Azarbaijan University of Medical Sciences, Resalat Blvd, urmia
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.UMSU.REC.1402.040

Health conditions studied

1

Description of health condition studied
inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene

Primary outcomes

1

Description
intensity of pain
Timepoint
At 60, 90 minutes and 24 hours after surgery
Method of measurement
Based on numeric rating scale (NRS)

2

Description
The consumption of opioids for pain after surgery
Timepoint
Up to 24 hours after the surgery
Method of measurement
Based on milligrams

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In ketamine group, Induction of anesthesia is done with 1 to 4 mg/kg of intravenous ketamine, and then in maintenance phase, intravenous perfusion of ketamine at a rate of 2 to 10 μg/kg/min will be prescribed.
Category
Treatment - Drugs

2

Description
Control group: In fentanyl group, induction of anesthesia is performed with 1-2 μg/kg fentanyl as a routine anesthetic drug, and then maintenance phase, continuous infusion of fentanyl at a rate of 1-2 μg/kg/hr will be prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Urmia Imam Khomeini educational and medical center
Full name of responsible person
Ali Akbar Nasiri
Street address
Imam Khomeini Educational and Medical Center, Ershad St., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Fax
+98 44 3346 9935
Email
Nasiriali7@gmail.com
Web page address
https://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
Research and Technology Vice-Chancellor, West Azarbaijan University of Medical Sciences and Healthcare Services, Emergency Room, Resalat Blvd., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57146154637
Phone
+98 44 3223 1930
Email
sabergholizadeh@yahoo.com
Web page address
http://umsu.ac.ir
Grant name
Urmia University of Medical Sciences
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
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
Oroumia University of Medical Sciences
Full name of responsible person
Ali Akbar Nasir
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Educational and Medical Center, Ershad St., Modares Blvd., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 7286
Email
Nasiriali7@gmail.com
Web page address
https://umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ali Akbar Nasiri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Educational and Medical Center, Ershad St., Modares Blvd., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 7286
Email
Nasiriali7@gmail.com
Web page address
https://umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Ali Akbar Nasiri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Educational and Medical Center, Ershad St., Modares Blvd., Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 7286
Email
Nasiriali7@gmail.com
Web page address
https://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
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