Determination the sedative effect of intranasal fentanyl and intranasal ketamine in phacoemulsification cataract surgery under sedation
Design
This prospective, randomized, double-blinded clinical trial . The study protocol was approved by the Anesthesiology Department and Ethic Committee of Deputy of Research of Isfahan University of Medical Sciences.
Patients aged 30–75 years old scheduled for phacoemulsification cataract surgery under topical anesthesia In Feiz hospital were included in the study.each group contains 40 persons.
Settings and conduct
Randomized double-blind Clinical trial based on random numbers
Participants/Inclusion and exclusion criteria
Inclusion: patients who are candidates for cataract surgery; consent to participate in the study; patients aged 30-75 years old; patients with ASA class 1 and 2.
Exclusion: history of allergy or allergic reaction to each of the study drugs; history of head injury; cardiovascular risk; hypertension; severe respiratory disease; advanced liver disease; epilepsy or history of seizure; nervous system disorders; the presence of any tumor or brain metastasis; use of any analgesic and anesthetic drugs; chronic pain syndrome; patients who are not satisfied to enter the study; pregnant women.
Intervention groups
In ketamine group intranasal ketamine 2 ml (1.5 mg/Kg) with maximum dosage of 100 mg administered in both nostrils. In fentanyl group intranasal fentanyl 2 ml (1.5 mcg/Kg) with maximum dosage of 100 mc administered in both nostrils. Both groups received intravenous midazolam 0.04 mg/kg 5 min before surgery. Propofol 2 ml (5mg/ml) as rescue sedative syringe was available to patients in both groups and was administered if the patient was still anxious.
Main outcome variables
Sedation level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170809035601N11
Registration date:2019-07-16, 1398/04/25
Registration timing:prospective
Last update:2019-07-16, 1398/04/25
Update count:0
Registration date
2019-07-16, 1398/04/25
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 2105
Email address
hamidshetabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the sedative effect of intranasal fentanyl and intranasal ketamine in phacoemulsification cataract surgery under sedation
Public title
Comparing the sedative effect of intranasal fentanyl and intranasal ketamine in phacoemulsification
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for Phacoemulsification cataract surgery
Patients who are satisfied to enter the study
Patients aged 30-75 years old
patients with ASA class 1 and 2
Exclusion criteria:
History of any allergy or allergic reaction to any of medications used in the study
History of head injurys
High intraocular pressure or intracranial pressure
Cardiovascular risk
Hypertension
Severe respiratory disease
Advanced liver disease
Epilepsy or history of seizure
Nervous system disorders
The presence of any tumor or brain metastasis
Use of any analgesic and anesthetic drug
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In the operating room, based on a random number table, one of the compounds of intranasal fentanyl or intranasal 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 Isfehan University of Medical Sciences
Street address
Isfehan University of Medical Sciences and Health Services, Building No.4, Research and Technology Deputy of University,Hezar Jarib Street, Isfahan town
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.MUI.MED.REC.1398.129
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
Timepoint
After induction of anesthesia, during the procedure every 5 minutes
Method of measurement
Modified ramsay sedation scale (RSS)
Secondary outcomes
1
Description
Mean Atrial Pressure
Timepoint
Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Pressure gauge
2
Description
Oxygen saturation percentage
Timepoint
Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Pulse oximetry
3
Description
Heart rate
Timepoint
Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Pulse oximetry
4
Description
Adverse drug reaction
Timepoint
Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Adverse drug reaction questionnaire
5
Description
Recovery time
Timepoint
From the end of the surgery to the time exit Recovery
Method of measurement
Minute
6
Description
Surgeon satisfaction
Timepoint
End of surgery
Method of measurement
Likert scale
Intervention groups
1
Description
Intervention group: ketamine group intranasal ketamine 2 ml (1.5 mg/Kg) with maximum dosage of 100 mg administered in both nostrils
Category
Treatment - Drugs
2
Description
Intervention group: fentanyl group intranasal fentanyl 2 ml (1.5 mcg/Kg) with maximum dosage of 100 mc administered in both nostrils
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faiz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Toghchi
City
Isfehan
Province
Isfehan
Postal code
7346181764
Phone
+98 31 3445 2035
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
Shaghyegh Haghjoo Javanmard
Street address
Vice chancellor of research and technology of university, Isfahan University of Medical Sciences, Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
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
Hamidreza shetabi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares st
City
Isfahan
Province
Isfehan
Postal code
7346181746
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
Assisstant profesor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Faiz hospital, Modares st.
City
Isfehan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8138
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, Modares st
City
Isfahan
Province
Isfehan
Postal code
7346181764
Phone
+98 31 3668 8138
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
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period one year after the publication of results
To whom data/document is available
Only available for scholars working in academic and academic centers
Under which criteria data/document could be used
Use of data is permitted for the purpose of developing research on the use of the drug
From where data/document is obtainable
To the email address of the corresponding author
What processes are involved for a request to access data/document
Within two weeks, the requested information will be provided to the applicant