Comparative study of the effect of intravenous Dexmedotomidian and Fentanyl in comparison with Midazolam and Sufentanyl on pain severity, surgen consent, patient sedation, hemodynamic status after cataract surgery
Comparison of the effect of intravenous dexmedetomidine and fentanyl with intravenous midazolam and sufentanil on patient pain intensity, surgeon satisfaction, patient sedation, and hemodynamic status after cataract surgery.
Design
A controlled, double-blind, randomized clinical trial of 80 patients, phase 3, block randomization according to the website.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
Settings and conduct
The study will be conducted in Farshchian Sina Hospital in Hamedan. 2 drops of 0.5% tetracaine are instilled in the eyes of all patients. The surgeon and the patient are blind. During surgery and intervention, the patient's vital signs such as: blood pressure, heart rate and oxygen saturation level are measured. In the intervention group, 2 micrograms/kg per hour of dexmedetomidine and 1 cc of fentanyl are injected intravenously. In the control group, 1 mg of midazolam and 1 cc of sufentanil are injected.Surgery in both groups is performed by phyco-emulsification. After transfer of patients to recovery, the vital signs checke. Using visual pain scale (VAS). The surgeon satisfaction is asked by interview . The hemodynamic status of the patients and the level of sedation are recorded with the Ramsay scale.
Participants/Inclusion and exclusion criteria
ASA1&2
cataract surgery by phacoemulsification
Intervention groups
In the intervention group, the use of intravenous dexmedetomidine and fentanyl drugs. Sufentanil and midazolam drugs are used in the control group.
Main outcome variables
Patient's pain, surgeon's satisfaction, patient's hemodynamic status, patient's sedation status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231231060584N1
Registration date:2024-01-27, 1402/11/07
Registration timing:registered_while_recruiting
Last update:2024-01-27, 1402/11/07
Update count:0
Registration date
2024-01-27, 1402/11/07
Registrant information
Name
Zahra Ataei Barazandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 5389
Email address
za.ataeibarazandeh@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of intravenous Dexmedotomidian and Fentanyl in comparison with Midazolam and Sufentanyl on pain severity, surgen consent, patient sedation, hemodynamic status after cataract surgery
Public title
study of the effect of Dexmedetomidine and Fentanil on pain severity and hemodynamic status on catarct surgeries patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA 1&2
not use of drugs and strong painkillers chronically
cataract surgery by phacoemulsification
Exclusion criteria:
ASA 3
use of another drug inside of study drugs
Age
From 45 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The research units are placed in two intervention and control groups with easy sampling and random allocation. The random method is block random. The random sequence and block are extracted from the following website.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in the study (patients) do not know in which group 1 or 2 they are. The surgeon does not know which group 1 or 2 the patient will be operated on.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Mirzadeh Eshghi Ave, Farshchian Sina Hospital
City
Hamedan
Province
Hamadan
Postal code
6516783736
Approval date
2023-12-30, 1402/10/09
Ethics committee reference number
IR.UMSHA.REC.1402.623
Health conditions studied
1
Description of health condition studied
Cataract surgery by phacoemulsification
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
pain severity
Timepoint
0-30-60 minutes after surgery
Method of measurement
VAS scale
Secondary outcomes
1
Description
patient sedation
Timepoint
0-30-6- minutes after surgery
Method of measurement
RAMSEY scale
Intervention groups
1
Description
Intervention group: Dexmedetomidine 1 microgram/kg and Fentanyl 1 mg/kg are used intravenously during surgery. (Both drugs must be injected on each patient.)
Category
Treatment - Drugs
2
Description
Control group: Sufentanil 1 mg/kg and midazolam 1 mg/kg are used as intravenous injections during surgery. (Both drugs must be injected to each patient.)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Sina Hospital, eye operating room
Full name of responsible person
Behzad Imani
Street address
Pastor Crossroad, Mirzadeh Eshghi st. Farshchian Sina Hospital
City
Hamedan
Province
Hamadan
Postal code
6516738736
Phone
+98 81 3827 4184
Fax
+98 81 3826 9808
Email
behzadiman@yahoo.com
Web page address
http://www.umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behzad Imani
Street address
Shahid Fahmide Blvd, Hamedan University of Medical Science
City
Hamedan
Province
Hamadan
Postal code
6516738736
Phone
+98 81 3131 0000
Email
Behzadiman@umsha.ac.ir
Web page address
http://www.umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Behzad Imani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh Blvd, Hamedan University
City
Hamedan
Province
Hamadan
Postal code
6516738736
Phone
+98 81 3131 0000
Email
Behzadiman@yahoo.com
Web page address
http://www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behzad Iman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmide Blvd, Hamedan University
City
Hamedan
Province
Hamadan
Postal code
6516738736
Phone
+98 81 3131 0000
Email
Behzadiman@yahoo.com
Web page address
http://www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behzad Imani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmide Blvd, Hamedan University
City
Hamedan
Province
Hamadan
Postal code
6516738736
Phone
+98 81 3131 0000
Email
BehzadIman@yahoo.com
Web page address
http://www.umsha.ac.ir
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
It will be available after the end of sampling.
When the data will become available and for how long
It will be available after the end of sampling.
To whom data/document is available
It will be available after the end of sampling.
Under which criteria data/document could be used
It will be available after the end of sampling.
From where data/document is obtainable
It will be available after the end of sampling.
What processes are involved for a request to access data/document