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Comparison of preventive effects of Ketamine ,fentanyl and paracetamol on Hemodynamic parameters and acute postoperative pain after deep vitrectomy

Protocol summary

Study aim
Determining the effect of prophylactic administration of ketamine, fentanyl and paracetamol on hemodynamic parameters and severity of acute pain after deep vitrectomy and comparison with control group
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 80 patients. Random allocation software is used for randomization
Settings and conduct
Randomized double-blind clinical trial (physician and patient and data analyzer are not aware of the type of drug combination used) which is performed in 2021 in Feyz Educational-Medical Center of Isfahan Before starting the project, the sequence of patients in 4 groups is determined using random allocation software and patients are divided into 4 groups receiving ketamine , group receiving fentanyl , paracetamol receiving group and control group. they take 15 minutes before the operation with the coordination of the surgeon of the studied drugs Will be given intravenously And delivered in covered syringes with a code. The medicine is prepared by an operating room technician and the doctor is unaware of the contents of the syringe
Participants/Inclusion and exclusion criteria
inclusion criteria : Patients in the age range of 40-80 years, with ASA class 1 and 2, candidates for elective deep vitrectomy under general anesthesia exclusion criteria : Pregnancy, history of smoking, drug and alcohol addiction, if the duration of surgery is less than one and more than three hours
Intervention groups
Patients in the intervention group include canide patients undergoing vitrectomy receiving fentanyl, paracetamol, and ketamine. Patients in the intervention group include canidectomy patients receiving normal saline serum.
Main outcome variables
Evaluation of hemodynamic changes after deep vitrectomy surgery; Evaluation of pain after deep vitrectomy surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201213049697N1
Registration date: 2021-09-07, 1400/06/16
Registration timing: retrospective

Last update: 2021-09-07, 1400/06/16
Update count: 0
Registration date
2021-09-07, 1400/06/16
Registrant information
Name
Mohamad Razani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4324 1452
Email address
razani113774@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-16, 1399/09/26
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of preventive effects of Ketamine ,fentanyl and paracetamol on Hemodynamic parameters and acute postoperative pain after deep vitrectomy
Public title
Comparison of preventive effects of Ketamine ,fentanyl and paracetamol on Hemodynamic parameters and acute postoperative pain after deep vitrectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
all patient candidate for deep vitrectomy surgery
Exclusion criteria:
each surgery that long more than 3 or less than 1 hour pregnancy addiction to cigarette ,opium and alcohol Inability to speak non iranian nationality more than 100 kg weight choronic pain that last more than 6 month uncontroled systemic diseases such as liver or kidney disease allergy or anaphylaxy to NSAID ,opium and drug that we use in study psychosis ,obvious anxiety before surgery and History of taking anti-anxiety medication
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the project, the sequence of patients in 4 groups is determined using random allocation software And patients are divided into 4 groups receiving ketamine (group K), group receiving fentanyl (group (f), group receiving paracetamol (group p) and control group It(drug) is delivered in covered syringes and has a code. The medicine is prepared by an operating room technician and the doctor is unaware of the contents of the syringe. Randomization is simple. It is an individual randomization unit. Randomization is done by random allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
Prior to surgery, patients will be told that their pain intensity and hemodynamic parameters will be assessed after surgery, patients will be told if they are compared to other groups, and then their consent form will be obtained Becomes The medicine is prepared by an operating room technician and the doctor is unaware of the contents of the syringe In order for the study to be bi-blind, two different people will be used so that the anesthesiologist will prescribe the medication And the other person does not know the type of drug used Collects data and analyzes information. In fact, the drugs are prepared by the anesthesia technician and delivered to the anesthesiologist in sealed and numbered syringes. The anesthesiologist does not know the type of drug injected into the patient. Also, data related to the study during and after the operation will be collected and analyzed by someone other than the anesthesiologist and anesthesiology Technician
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
esfahan university of medical science, Hezar jarib Ave ,Darvaze shiraz square
City
esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-12-03, 1399/09/13
Ethics committee reference number
IR.MUI.MED.REC.1399.787

Health conditions studied

1

Description of health condition studied
Most cases of vitrectomy are performed due to retinal detachment for any reason, including diabetes, trauma, etc.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hemodynamic changes (blood pressure, respiration rate, heart rate, blood oxygen saturation)
Timepoint
Before the operation, during the operation (at intervals of 15 minutes, 30 minutes, one hour, two hours), after the operation (at intervals of 15 minutes, 30 minutes, one hour, two hours, 4 hours, 16 hours , 24 hours )
Method of measurement
Mercury sphygmomanometer, clock, pulse oximeter

2

Description
Acute pain after surgery
Timepoint
Before the operation, during the operation (at intervals of 15 minutes, 30 minutes, one hour, two hours), after the operation (at intervals of 15 minutes, 30 minutes, one hour, two hours, 4 hours, 16 hours , 24 hours )
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Ketamine (Group K) 0.5mg / kg will be opened by intravenous infusion within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution .Drug of a special pharmaceutical factory is not consider .The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals.
Category
Treatment - Drugs

2

Description
Intervention group: The fentanyl group receiving 2mcg / kg will be infused intravenously within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution. Drug of a special pharmaceutical factory is not consider . The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals.
Category
Treatment - Drugs

3

Description
Intervention group: Paracetamol group receiving 10 mg / kg will be infused intravenously within 15 minutes after the volume of the above drugs is increased to 100 cc by sterile normal saline solution. Drug of a special pharmaceutical factory is not consider . The duration of the patient follow-up period after injecting drugs is 24 hours, which the patient's vital signs, pain intensity, and medications are recorded at specified intervals.
Category
Treatment - Drugs

4

Description
Control group: 100 cc normal saline for 15 minutes intravenously
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Mohamad Razani
Street address
Isfahan - Ghods Square - Modares Street - Feyz Hospital
City
ESFAHAN
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2031
Email
RAZANI113774@GMAIL.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
SHAGHAYEGH HAGHJO
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
ESFAHAN
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
RAZANI113774@GMAIL.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Darioush Moradi Farsani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
drdmoradi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
031 3668 81388
Email
drdmoradi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi Farsani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
031 3668 81388
Email
drdmoradi@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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
In this study, only data related to the effect of drugs on hemodynamic parameters and acute postoperative pain will be published and potential data information will be published only after the necessary coordination with the executor and ensuring the scientific rank and purpose of the person requesting the information.
When the data will become available and for how long
One year 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 data will be provided to the mentioned people for comparative studies as well as systematic studies
From where data/document is obtainable
razani113774@gmail.com ,Mohammad Razani, Isfahan University of Medical Sciences 09381793755 ,Mohammad Razani, Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Depending on the type of information requested, the person communicates with the researcher through the channels provided and finally receives his / her answer within one month.
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