Comparison of two anesthesia techniques, Isoflurane versus Propofol, on Intraocular Pressure (IOP) changes during prone position in laminectomy surgery
Comparison of two anesthesia techniques, Isoflurane versus Propofol, on intraocular pressure (IOP) changes during prone position in laminectomy surgery
Design
Phase 3, randomized clinical trial; Block randomization (blocks of size 4) using computer; Without blinding; with control group and parallel group design; sample size will be 64,.
Settings and conduct
This study will be conducted at the Amiralmomenin Medical Center of Rasht.After obtaining informed consent from patients, four groups of randomized blocks will be studied in two intervention and control groups
In one group, the following anesthetic drugs will be used:
Premedication : fentanyl 3-5 μg/kg midazolam 1-2 mg
Induction:propofol 2-2/5 mg/kg- -cisatracuriom 0/2mg/kg
Maintenance: Isofluran N2O
In the other group:
Premedication : fentanyl 3-5 μg/kg midazolam 1-2 mg
Induction:propofol 2-2/5 mg/kg- -cisatracuriom 0/2mg/kg
Maintenance: Propofol N2O
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidates for laminectomy
Exclusion criteria:Eye disease history, Prohibition pron position, Prohibition of the use of toneupen, No use of any eye drops, No history of glaucoma and eye hypertension
Intervention groups
Intervention group: Anesthesia with isoflurane N2O
Control group: Anesthesia with propofol N2O
Main outcome variables
Intraocular pressure changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140310016917N7
Registration date:2018-11-30, 1397/09/09
Registration timing:prospective
Last update:2018-11-30, 1397/09/09
Update count:0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
Ali Ashraf
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 0434
Email address
aliashraf@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two anesthesia techniques, Isoflurane versus Propofol, on Intraocular Pressure (IOP) changes during prone position in laminectomy surgery
Public title
Comparison of propofol and isoflurane on intraocular pressure changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for laminectomy
Exclusion criteria:
Eye disease history
Prohibition pron position
Prohibition of the use of toneupen
No use of any eye drops
No history of glaucoma and eye hypertension
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks of size 4 using statistical software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4193893345
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.GUMS.REC.1397.246
Health conditions studied
1
Description of health condition studied
Candidates for laminectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in intraocular pressure
Timepoint
In 5 turns:1. The patient supine position before induction of anesthesia (baseline phase) 2.Anesthesia (in the first supine position) 3.Anesthesia (in the first prone position) 4. End-stage surgery(in the second prone position) 5.Supine final step before awakening
Method of measurement
With toneupen device, Richter Model
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Anesthesia will be done with Isoflurane USP and N2O. In Premedication stage Remifentanyl 0.5 μg/kg and Midazolam 2 mg will be used intravenously. In Induction stage, Propofol 2 mg/kg and Cisatracuriom 0/2mg/kg intravenously and in Maintenance stage, Isofluran USP 1.5% and N2O will be used By anesthesia machine. Propofol: Manufactured by DONGKOOK PHARM Company, South Korea, imported by TEDA Company. Isofeloran UPS: Manufactured by Bethehem Company, America, imported by TEDA Company.
Category
Treatment - Drugs
2
Description
Control group: Anesthesia will be done with propofol and N2O. In Premedication stage Remifentanyl 0.5 μg/kg and Midazolam 2 mg will be used intravenously. In Induction stage, Propofol 2 mg/kg and Cisatracuriom 0/2mg/kg will be used intravenously and In Maintenance stage NO2 Inhaler through anesthesia machine and 2 mg/kg Propofol1% will be used. Propofol: Manufactured by DONGKOOK PHARM Company, South Korea, imported by TEDA Company. Isofeloran UPS: Manufactured by Bethehem Company, America, imported by TEDA Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmoemenin hospital
Full name of responsible person
Ali Ashraf
Street address
Dr. Heshmati Square., Shahrivar St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3323 6886
Fax
+98 13 3323 6886
Email
crdu.Poursina@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Shahid Siyadati street, Namjoo street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3333 6394
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Grant name
Namjoo Street, Shahid Siadati, Rasht
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Prastar street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2250
Email
aliashraf@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2250
Email
aliashraf@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2250
Email
aliashraf@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD