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Comparison of fentanyl pump analgesia (PCA) with the combination of morphine, ketamine and lidocaine on pain after coronary artery bypass grafting (CABG)

Protocol summary

Study aim
Comparison of fentanyl pump analgesia (PCA) with the combination of morphine, ketamine and lidocaine on pain after coronary artery bypass grafting (CABG) in Shahid Mohammadi Hospital in Bandar Abbas During in 2024
Design
A comparative, double-blind, randomized clinical trial, phase 2 on 60 patients, rand function of Excel software was used for randomization.
Settings and conduct
After surgery, patients will be transferred to the ICU under full care. Patients will be randomly divided into two groups. The first group, the group receiving fentanyl (500 mcg in a diluted solution of 100 cc of distilled water at a rate of 4 cc per hour) and the second group, the group receiving morphine (20 mg), ketamine (20 mg) and lidocaine (200 mg) at a rate of 4 cc per hour with a pain pump. Also, the demographic characteristics of the patients (age, gender, weight and height) were recorded in the researcher-made questionnaire by the anesthesiologist who was not aware of the type of intervention and the patient's condition and pca pump. It should be noted that pain relief pumps do not contain any information about the drug or drugs used in the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidates for elective CABG surgery Patients 30-80 years old Anesthesia class II, III exclusion criteria: Pump time more than 120 minutes Simultaneous valve and CABG ,Emergency surgery
Intervention groups
The intervention group includes patients who are candidates for CABG surgery who receive fentanyl analgesia pump after the operation The intervention group includes patients who are candidates for CABG surgery, who receive the combined analgesia pump of morphine, ketamine and lidocaine after the operation.
Main outcome variables
systolic blood pressure؛ diastolic blood pressure؛mean arterial pressure؛nausea and vomiting rate ؛ average patient pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231227060539N1
Registration date: 2024-01-28, 1402/11/08
Registration timing: prospective

Last update: 2024-01-28, 1402/11/08
Update count: 0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
Iman Zafarasoodeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
izawlm72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fentanyl pump analgesia (PCA) with the combination of morphine, ketamine and lidocaine on pain after coronary artery bypass grafting (CABG)
Public title
Investigating the effect of fentanyl with the combination of morphine, ketamine and lidocaine in pain after open heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for elective CABG surgery Patients 30-80 years old Anesthesia class II, III Not receiving painkillers within 6 hours before surgery surgeryConsent to participate in the study EF > 40% Patients without a history of renal, hepatic, gastrointestinal, or pulmonary failure No alcohol or drug addiction
Exclusion criteria:
Pump time more than 120 minutes Simultaneous valve and CABG CABGReoperation to control bleeding and progressive heart failure (requiring high dose postoperative inotropes or IABP) Emergency surgery
Age
From 30 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
After the operation, the patient goes to the ICU, neither the patient nor the resident knows about the syringe pump drugs.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of hormozgan university of medical sciences
Street address
Hormozgan university of medical sciences. Blo. Shahid chamran. Bandar Abbas
City
bandar abbas
Province
Hormozgan
Postal code
1388579166
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
IR.HUMS.REC.1402.393

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
I50.4
ICD-10 code description
Combined systolic (congestive) and diastolic (congestive) heart failure

Primary outcomes

1

Description
Measurement of pain score in patients undergoing cabg
Timepoint
Pain score in hours 1, 2, 6, 12 after cabg patients
Method of measurement
Numeric rating scale for pain

Secondary outcomes

1

Description
The level of patient satisfaction
Timepoint
1, 2, 6, 12 hours after surgery
Method of measurement
Visual analogue scale

2

Description
Average systolic blood pressure
Timepoint
1,2,6,12 hours after surgery
Method of measurement
Blood pressure cuff

3

Description
Average diastolic blood pressure
Timepoint
1,2,6,12 hours after surgery
Method of measurement
Blood pressure cuff

4

Description
Average mean arterial pressure
Timepoint
1,2,6,12 hours after surgery
Method of measurement
Blood pressure cuff

5

Description
Average heart rate
Timepoint
1,2,6,12 hours after surgery
Method of measurement
Chest lead monitoring

6

Description
Average pain of patients
Timepoint
1,2,6,12 hours after surgery
Method of measurement
Numeric rating scale

Intervention groups

1

Description
The first intervention group, the group receiving fentanyl(Caspian Pharmaceutical Company) (500 mcg in a diluted solution of 100 cc of distilled water at a rate of 4 cc per hour)
Category
Treatment - Drugs

2

Description
The second intervention group received morphine (Aborehan pharmaceutical company) (20 mg), ketamine (Elixir pharmaceutical company) (20 mg) and lidocaine (Caspin pharmaceutical company) (200 mg) in a diluted solution of 100 cc Distilled water at a speed of 4 cc per hour with the pump.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid mohammadi hospital
Full name of responsible person
Iman Zafar Asoodeh
Street address
Shahid Mohammadi Hospital,Jomhoori Eslami St,Emam Khomeini St,Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3333 3280
Email
Izawlm72@gmail.com
Web page address
http://shmh.hums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr hashem jari neshin
Street address
Hormozgan University Of Medical Sciences,BLO Shahid Chamran,Bandar ABBas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Fax
+98 76 3333 3280
Email
Info@hums.ac.ir
Web page address
https://www.hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Doctor Saiid Kashani
Position
Associate Professor, Department of Anesthesiology, Hormozgan University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital,Jomhoori Eslami St,Emam Khomeini St,Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3333 3280
Email
sdkashani486@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Doctor Hashem Jari Neshin
Position
Professor of the Department of Anesthesiology, Hormozgan University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital,Jomhoori Eslami St,Emam Khomeini St,Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3333 3280
Email
sdkashani486@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Iman Zafar Asoodeh
Position
Anesthesiologist resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital,Jomhoori Eslami St,Emam Khomeini St,Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7000
Fax
+98 76 3333 3280
Email
Izawlm72@gmail.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information of intervention patients can be shared after de-identification
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The conditions are as follows: People related to clinical groups Inclusion of my name and colleagues in the desired research
From where data/document is obtainable
Email Izawlm72@gmail.com Iman zafar Asoodeh
What processes are involved for a request to access data/document
After sending the email and checking the request, the response will be done within 48 hours
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