Protocol summary

Study aim
Determination of the sedation effect of fentanyl-etoimidate, fentanyl-propofol and fentanyl-midazolam on Phacoemulsification
Design
randomized double-blind Clinical trial based on random numbers
Settings and conduct
In this study, both the participants and the data collector were blind to the allocation of the participants into propofol, midazolam and etomidate groups. The study drugs were prepared in 4 syringes covered with aluminum foil, by an anesthesiologist who was not involved in data collection.1
Participants/Inclusion and exclusion criteria
Inclusion: Patients who are candidates for cataract surgery, Consent to Participate in the Study, Patients aged 35-85 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
Intervention group: Patients received fentanyl in 1.5 mg / kg dose In the group (E), they receive an etomidat at a dose of 0.1 mg / kg. If needed, 4 mg of the etomidate will be injected and recorded as a rescue dose. ​At the end of the dose, the total dose is recorded. In group (P), receive propofol at a dose of 0.5 mg/kg. If needed, 20 mg of propofol will be injected and recorded as a rescue dose. At the end of the dose, the total dose is recorded. In group (M), midazolam is given at a dose of 0.04 mg/kg. If needed, 2 mg of midazolam will be injected as a rescue dose. At the end of the dose, the total dose is recorded.
Main outcome variables
Sedation level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170809035601N10
Registration date: 2018-12-29, 1397/10/08
Registration timing: retrospective

Last update: 2018-12-29, 1397/10/08
Update count: 0
Registration date
2018-12-29, 1397/10/08
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
2017-11-01, 1396/08/10
Expected recruitment end date
2018-06-30, 1397/04/09
Actual recruitment start date
2017-11-06, 1396/08/15
Actual recruitment end date
2018-06-30, 1397/04/09
Trial completion date
2018-06-30, 1397/04/09
Scientific title
Comparison of fentanyl-etomidate, fentanyl-propofol and fentanyl-midazolam for sedation in phacoemulsification
Public title
The effect of sedation of fentanyl-etomidate, fentanyl-propofol and fentanyl-midazolam in phacoamulsification
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 35-85 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 injury 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 drugs Chronic pain syndroms Patients who are not satisfied to enter the study Pregnant women
Age
From 35 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 150
More than 1 sample in each individual
Number of samples in each individual: 50
One sample at each participant
Actual sample size reached: 99
Randomization (investigator's opinion)
Randomized
Randomization description
In the operating room, based on a random number table, one of the compounds of fentanyl- etomidate, fentanyl- propofol and fentanyl -midazolam is given to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both the participants and the outcomes Assessor were blind to the allocation of the participants into groups of fentanyl- etomidate, fentanyl- propofol and fentanyl -midazolam . The study drugs were prepared in 4 syringes covered with aluminum foil, by an anesthesiologist who was not involved in data collection.
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
2018-12-01, 1397/09/10
Ethics committee reference number
IR.MUI.MED.REC.1397.150

Health conditions studied

1

Description of health condition studied
Cataract surgery
ICD-10 code
H26.9
ICD-10 code description
Cataract surgery

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

7

Description
Patient satisfaction
Timepoint
End of Recovery
Method of measurement
Likert scale

Intervention groups

1

Description
Intervention group: patients in group (E )received 0.1 mg/kg etomidate. In case of need, 4 mg etomidate will be injected as a rescue dose. At the end of the prescribed total dose is recorded.
Category
Treatment - Drugs

2

Description
Intervention group: patients in group (P) received 0.5 mg/kg propofol. In case of need, 20 mg propofol will be injected​ as a rescue dose. At the end of the prescribed total dose is recorded.
Category
Treatment - Drugs

3

Description
Intervention group: patients in group (M) received 0.04 mg/kg midazolam. In case of need, 2 mg midazolam will be injected as a rescue dose. At the end of the prescribed total dose is recorded.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faiz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Faiz Hospital, Modares st
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
Isfahan University of Medical Sciences
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
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