Comparing the premedication effects of Fentanyl and Ketamine on perioperative hemodynamic stability and postoperative pain in patients undergoing general anesthesia using laryngeal mask for cataract surgery
Comparing the premedication effects of Fentanyl and Ketamine on perioperative hemodynamic stability and postoperative pain in patients undergoing general anesthesia using
Design
A double-blind clinical trial in which patients are randomly divided into two groups, A and B.
Settings and conduct
In this clinical trial patients are not aware of the grouping, the drugs are coded and prepared by the nurse anesthetist and provided to the researcher (who observe and record the research process).This study is performed in Kowsar Hospital in Sanandaj, Kurdistan, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria : patients with cataracts; being at I & II level of ASA Classification; age between 40-70 years; consent to participate in the study
Exclusion criteria: confirmed ,suspicious or in treatment Schizophrenia;
hydrocephalus brain mass resulting in raised Intracranial pressure; thyroid porphyria; untreated cardiovascular disease; opium abuse during last week before operation, using corticosteroid ; untreated ear disease and vertigo
uncontrolled hypertension; acute or chronic lung disease; obesity (BMI>30) and operation time lasting more than one hour.
Intervention groups
Intervention group A: In this group, 0.3 mg / kg of ketamine is prescribed as a premedication for patients. After 3 minutes, 1.5 mg / kg intravenous administration of propropofol will be performed.Intervention group B: In this group, µgr/kg 1.5 fentanyl is prescribed as a premedication for patients. After 3 minutes, 1.5 mg / kg intravenous administration of propropofol will be performed.
Main outcome variables
Mean arterial pressure, heart rate during surgery and postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210214050355N1
Registration date:2021-05-25, 1400/03/04
Registration timing:registered_while_recruiting
Last update:2021-05-25, 1400/03/04
Update count:0
Registration date
2021-05-25, 1400/03/04
Registrant information
Name
Mehran Rami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3338 5818
Email address
mehran.rami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the premedication effects of Fentanyl and Ketamine on perioperative hemodynamic stability and postoperative pain in patients undergoing general anesthesia using laryngeal mask for cataract surgery
Public title
Evaluating the premedication effects of Fentanyl and Ketamine on perioperative hemodynamic stability and postoperative pain in patients undergoing general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cataracts
Age 40 to 70 years
Being at level 1 and 2 of the ASA system
Consent to participate in research
Exclusion criteria:
Uncontrolled Cardiovascular disease
Opioids abuse during the weak before operation
Patients who are taking corticosteroids
Ear disorders and Vertigo
Uncontrolled Diabetes Mellitus
Uncontrolled Hypertension
Acute or chronic Pulmonary diseases
Obesity (BMI>30)
Probable Schizophrenia; Schizophrenia and in treatment Schizophrenia
Brain mass; Hydrocephalus; Raised ICP
Porphyria
Thyroid malfunction
Patients whose operation lasts more than an hour
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
The sample will be assigned to 2 groups at random so that patients with the condition are assigned to the researcher in the form of a double block (AB) by the researcher. Then a pack containing 49 cards with one of the letters A and B (44 each) is considered to randomly select a card from the package and enter one of the groups according to the Latin letter. Sampling is done in parallel in 2 groups until the number of samples is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are not aware of the grouping, also the drugs are coded and prepared by the nurse anesthetist and provided to the researcher (who observe and record the research process).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St. Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2021-01-05, 1399/10/16
Ethics committee reference number
IR.MUK.REC.1399.265
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Pain
Timepoint
30 and 60 minutes after the end of anesthesia
Method of measurement
Visual analogue scale
2
Description
Mean Arterial Pressure
Timepoint
Induction time of venous anesthesia, After induction and before placement of laryngeal mask, Immediately after laryngeal mask placement, Ten minutes after induction of anesthesia,20 minutes after induction of anesthesia, Recovery Delivery Time, Recovery Discharge Time
Method of measurement
Barometer of medical monitoring device
3
Description
Harte Rate
Timepoint
Induction time of venous anesthesia, After induction and before placement of laryngeal mask, Immediately after laryngeal mask placement, Ten minutes after induction of anesthesia,20 minutes after induction of anesthesia, Recovery Delivery Time, Recovery Discharge Time
Method of measurement
Medical monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, patients have prescribed 0.3 mg/kg ketamine as a premedication. After 3 minutes, induction of anesthesia with propofol at a dose of 1.5 mg/kg intravenously will be done in one dose. The injection is a single dose and the drug is a product of STEROP company in Belgium.
Category
Treatment - Drugs
2
Description
Second intervention group: In this group, 1.5 fentanyl µgr/kg is prescribed as a premedication for patients. After 3 minutes, induction of anesthesia with propofol at 1.5 mg/kg intravenously will be performed. The injection is a single dose and the drug is a product of STEROP company in Belgium.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Mehran Rami
Street address
Pasdaran St., Kowsar Hospital
City
Sanandaj
Province
Kurdistan
Postal code
66168-12131
Phone
+98 87 3361 1233
Email
mehran.rami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran St., Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
maleki@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Mehran Rami
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran St., Kowsar Hospital
City
Sanandaj
Province
Kurdistan
Postal code
66168-12131
Phone
+98 87 3361 1233
Email
Mehran.Rami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzad Sarshivi
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran St., Kowsar Hospital
City
Sanandaj
Province
Kurdistan
Postal code
66168-12131
Phone
+98 87 3361 1233
Email
farzadsarshivi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Mehran Rami
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran St., Kowsar Hospital
City
Sanandaj
Province
Kurdistan
Postal code
66168-12131
Phone
+98 87 3361 1233
Email
Mehran.Rami@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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on the primary outcomes will be shared.
When the data will become available and for how long
Six months after the publication of the results data access is possible.
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
Meta-analysis is allowed.
From where data/document is obtainable
Dr. Mehran Rami via email: Mehran.Rami@gmail.com
What processes are involved for a request to access data/document
Three months after the request, the data will be sent.