Aim of this prospective observational study was the comparison of sedation /monitored anesthesia care versus general anesthesia in patients undergoing pars plana vitrectomy.
Design
In one group PPV will be done under general anesthesia and in the other group will be done under monitored anesthesia care(MAC) and conscious sedation.
Settings and conduct
If the patients could not tolerate IV sedation it can be converted to general anesthesia. Parameters were graded depending on the type of anesthesia: central eye position, anesthesia, akinesia of the eye and or body, soft tissue or orbital hemorrhage, and absence of vitreous bulge. Postoperatively quality of immobilization was assessed by a standardized questionnaire. spiteri et al. published and evaluated such a questionnaire in 2015. For the purpose of this study the questionnaire was slightly modified while leaving the core score system unchanged.
This study will performed at Khalili hospital at Shiraz, Fars, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who are cooperative for conscious sedation and candidate for pars plana vitrectomy.
Exclusion criteria:
1. patients who are uncooperative for conscious sedation
2. difficult surgeries
Intervention groups
40 patients who are candidate for 23 Gauge-pars plana vitrectomy(PPV) for vitreoretinal disorders will be included in this study and will be divided in to two groups.
Main outcome variables
Parameters were graded depending on the type of anesthesia: central eye position, anesthesia, akinesia of the eye and or body, soft tissue or orbital hemorrhage, and absence of vitreous bulge.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201120049450N3
Registration date:2024-03-04, 1402/12/14
Registration timing:registered_while_recruiting
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Ehsan Namvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 4088
Email address
namvar_e@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-10, 1402/11/21
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
Conscious sedation/monitored anesthesia care versus general anesthesia in patients undergoing pars plana vitrectomy
Public title
Performing retinal surgery without general anesthesia and comparing its benefits compared to performing the same surgery with general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who are cooperative for conscious sedation and candidate for pars plana vitrectomy
Exclusion criteria:
patients who are uncooperative for conscious sedation.
difficult surgeries
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Since patients received general anesthesia, therefore all patients and data analyzers were blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
shiraz khalili Hospital, Khalili street
City
Shiraz
Province
Fars
Postal code
7193636981
Approval date
2023-12-20, 1402/09/29
Ethics committee reference number
IR.SUMS.MED.REC.1402.455
Health conditions studied
1
Description of health condition studied
Retinal disorders
ICD-10 code
H35
ICD-10 code description
Other retinal disorders
Primary outcomes
1
Description
Parameters were graded depending on the type of anesthesia: central eye position, anesthesia, akinesia of the eye and or body, soft tissue or orbital hemorrhage, and absence of vitreous bulge.
Timepoint
After surgery
Method of measurement
The standardized questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention no.1 group (20 participants) PPV will be done under monitored anesthesia care(MAC) and conscious sedation.
Category
Treatment - Surgery
2
Description
Intervention group: In intervention no.2 group (20 participants) PPV will be done under general anesthesia.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili hospital
Full name of responsible person
Ehsan Namvar
Street address
Khalili hospital, Khalili, Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 917 713 4116
Email
Namvar_e@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar
Street address
Khalili hospital, Khalili, Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 917 713 4116
Email
Namvar_e@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan namvar
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital, Khalili, Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
Namvar_e@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital, Khalili, Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
Namvar_e@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Namvar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Khalili hospital, Khalili, Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
Namvar_e@sums.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
Conscious sedation/monitored anesthesia care versus general anesthesia in patients undergoing pars plana vitrectomy
The amount of pain
Suitability of eye position for surgery
eye immobility
No bleeding
Softness of the eyes
immobility of the body
Hemodynamic stability
When the data will become available and for how long
after publishing
To whom data/document is available
public
Under which criteria data/document could be used
َall of data
From where data/document is obtainable
under the web
What processes are involved for a request to access data/document