Comparison of the Effects of sublingual fentanyl and intravenous ketamine on pain control and hemodynamic variables in phacoemulsification cataract surgery under sedation and local anesthesia
Determining the effect of sublingual fentanyl in comparison with intravenous ketamine on pain control and hemodynamic parameters during and after cataract surgery by phycoemulsification under local sedation and anesthesia
Design
Double-blind randomized clinical trial on 86 patients candidates for cataract surgery in Feyz Hospital, Isfahan, randomization by random allocation software
Settings and conduct
place: Feyz Hospital, Isfahan;blinding: double-blind; the patient and the observer who collects the information are unaware of the drug grouping; Method: 86 patients (43 patients in each group) are candidates for cataract surgery in two groups of sublingual fentanyl at a dose of 1.5µ/kg and intravenous ketamine at a dose of 0.3 mg/kg. Propofol will be injected by infusion to induce sedation in both groups
Participants/Inclusion and exclusion criteria
Inclusion:Patients aged 50-75 with ASA class 1 and 2 that Candidates for phycoemulsification who are willing to enter the study
Exclusion:History of any allergic reaction to any of medications used in the study؛pregnancy؛seizure or psychotic disorder؛preoperative hypotention؛Taking medication preoperatively (other than those mentioned before)؛lesion of the oral cavity that interferes with sublingual administration of the drug؛increase intracranial pressure
Intervention groups
In the sublingual fentanyl group (SLF), fentanyl at a dose of 1.5µ/kg (up to 100µg) is administered sublingually to the patient, and in the intravenous ketamine group (IVK), ketamine at a dose of 0/3 mg/kg injected intravenously. To induce sedation in both groups, 15 ml of propofol (1%), which is reduced to 20 cc with 5 cc of 5% dextrose (containing 7.5 mg/ml of propofol) by infusion
pump at a rate of 0.4 ml/kg/h to receive propofol at a sedative dose of 50 micrograms per kilogram of body weight per minute
Main outcome variables
pain Control and hemodynamic parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N18
Registration date:2021-03-08, 1399/12/18
Registration timing:registered_while_recruiting
Last update:2021-03-08, 1399/12/18
Update count:0
Registration date
2021-03-08, 1399/12/18
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of sublingual fentanyl and intravenous ketamine on pain control and hemodynamic variables in phacoemulsification cataract surgery under sedation and local anesthesia
Public title
Comparison of the Effects of sublingual fentanyl and intravenous ketamine in phacoemulsification cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 50-75 with ASA (American Society of Anesthesiology) class 1 and 2 that Candidates for phycoemulsification cataract surgery who are willing to enter the study
Exclusion criteria:
History of any allergy or allergic reaction to any of medications used in the study
pregnancy
seizure or psychotic disorder
preoperative hypotention
Taking medication preoperatively (other than those mentioned before)
Inflammation or any lesion of the oral cavity that interferes with sublingual administration of the drug
increase intracranial pressure
Age
From 50 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
In the operating room, based on a random allocation software table , one of the compounds of sublingual fentanyl or intrvenous ketamine is given to patients
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the researcher are not aware of the type of medication used. Medications are prepared by an anesthetic expert who has no role in the study and then injected by an anesthetist to each patient group. The person who records the data is also unaware of the type of medication used
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services, Building No.4, Research and Technology Deputy of University,Hezar Jarib Street, Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-05-02, 1399/02/13
Ethics committee reference number
IR.MUI.MED.REC.1399.103
Health conditions studied
1
Description of health condition studied
cataract surgery
ICD-10 code
H26.9
ICD-10 code description
Unspecified cataract
Primary outcomes
1
Description
Sedation level based on ramsay score
Timepoint
every 5 minutes during surgery and then in recovery every 15 minutes, until discharge from recovery
Method of measurement
Ramsay score
Secondary outcomes
1
Description
Arterial blood pressure
Timepoint
Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery
Method of measurement
pressure gauge
2
Description
oxygen saturation
Timepoint
Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery
Method of measurement
Pulse oximeter
3
Description
Heart rate
Timepoint
Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery
Method of measurement
Pulse oximeter
4
Description
Intensity of pain
Timepoint
in recovery every 15 minutes, until discharge from recovery
Method of measurement
Universal Pain assessment tool
5
Description
recovery time
Timepoint
After surgery until the discharge from the recovery
Method of measurement
Minute Numbers
6
Description
Patient satisfaction
Timepoint
At the time of discharge from recovery
Method of measurement
Likert questionnaire
7
Description
Surgeon satisfaction
Timepoint
after surgery
Method of measurement
Likert questionnaire
8
Description
Adverse drug reaction
Timepoint
During surgery and in recovery
Method of measurement
Adverse drug reaction questionnaire
Intervention groups
1
Description
Intervention group: In the sublingual fentanyl (SLF) group, fentanyl at a dose of 1.5µ / kg (up to 100 micrograms), which is reduced to 2 ml with normal saline, is administered sublingually to the patient. first 2 cc fentanyl (up to 100 micrograms) is administered sublingually. After 10 minutes, we ask patients to remove the contents of their mouth and then 2 cc of normal saline is injected intravenously. To induce sedation propofol (1%) 15 ml, which is reduced to 20 cc with 5 cc of 5% dextrose (containing propofol 7.5 mg / ml) by infusion with a pump at a rate of 0.4 ml per Weight per hour to receive propofol at a sedative dose of 50 micrograms per kilogram of body weight per minute. If further sedation is required, a rescue dose of 2 cc propofol at a concentration of 5 mg / cc will be given as a bolus.
Category
Treatment - Drugs
2
Description
Control group: In intravenous ketamine (IVK) group, first 2 cc of normal saline is administered sublingually. After 10 minutes, we ask patients to remove the contents of their mouth and then ketamine at a dose of 0.3 mg / kg which is reduced to 2 ml with normal saline is injected intravenously. To induce sedation propofol (1%) 15 ml, which is reduced to 20 cc with 5 cc of 5% dextrose (containing propofol 7.5 mg / ml) by infusion with a pump at a rate of 0.4 ml per Weight per hour to receive propofol at a sedative dose of 50 micrograms per kilogram of body weight per minute. If further sedation is required, a rescue dose of 2 cc propofol at a concentration of 5 mg / cc will be given as a bolus.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Isfahan Modarres St. Feyz Hospital
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2031
Email
Hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Haghjooye Javanmard
Street address
Vice chancellor of research and technology of university, Isfahan University of Medical Sciences, Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
Hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modarres St
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Fax
Email
Hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modarres St
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2034
Email
Hamidshetabi@med.mui.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Unidentifiable individual data can be shared.
When the data will become available and for how long
6 months after publication of paper
To whom data/document is available
Only available to scholars working in academic and academic institutions
Under which criteria data/document could be used
Use for research and treatment purposes
From where data/document is obtainable
Email of the person in charge of public accountability: Hamidshetabi@med.mui.ac.ir
What processes are involved for a request to access data/document
after request via email, it will be sent if available within a maximum of 1 month.