Abstract:
Material and methods:
In a prospective and randomized clinical trial study eighty patients undergoing deep vitrectomy operations under general anesthesia were randomly allocated to receive either Isoflurane-Remifentanil (Group I ) or total intravenous anesthesia with Propofol-remifentanil (TIVA) (group P) for maintenance of anesthesia. Anesthesia was induced in both groups with remifentanil 1 μg.kg, propofol 2 mg/kg and Atracorium 0.6 mg/kg. Maintenance was achieved with 1 MAC of Isoflurane, O2 50% in air at 4 L/min and infusion of remifentanil 0.1 μg/kg/min-1 in I group. But in the P group we used propofol up to 10mg/kg iv with remifentanyl 0.1 µgr/kg iv for maintenance of anesthesia. Propofol infusion and desflurane were discontinued with the last surgical stitches, but remifentanil infusion continued in both groups until the eye was covered with shield. Hemodynamic variables were recorded during
the operation and one hour postoperatively in different intervals .
Keywords: vitrectomy, hemodynamics, intravenous, inhalation, anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010920588N2
Registration date:2015-10-06, 1394/07/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-06, 1394/07/14
Registrant information
Name
Darioush Moradi Farsani
Name of organization / entity
Isfahan Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 5555
Email address
dmoradi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Isfahan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic changes due to intravenous or inhalational anesthtics for deep vitrectomy surgery
Public title
Effect of inhalational and intravenous anesthetics on hemodynamic changes during surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The patients with American Society of anesthesiology class I and II aged 40-80 years who are candidate for deep Vitrectomy surgery.
Exclusion criteria: Any event that changes surgery or anesthesia technique.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization with random allocation table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medicasciences
Street address
Research Deputy, Isfahan university of medicasciences, Hezarjrib Street, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2014-12-11, 1393/09/20
Ethics committee reference number
13625 /8/د
Health conditions studied
1
Description of health condition studied
vitrectomy
ICD-10 code
H30-H36
ICD-10 code description
detachment of retinal pigment epithelium
Primary outcomes
1
Description
Systolic and dyastolic blood pressure
Timepoint
on arrival to recovery room, and then 30, 60, minutes and 2,4,8,16,24 hours after that.
Method of measurement
By blood pressure monitor in mmhg
Secondary outcomes
1
Description
Nausea & vomiting
Timepoint
Before induction of anesthesia, 1 minute after induction,
Method of measurement
By pulse oxymetery; non invasive blood pressure monitoring;
Intervention groups
1
Description
Intervention group 1 :we use propofol up to 10mg/kg iv with remifentanyl 0.1µgr/kg iv for maintenance of anesthesia. group. Intervention group 2 : Maintenance will achieve with 1 MAC of Isoflurane , O2 50% in air at 4 L.min and infusion of remifentanil 0.1 μg/kg/min
Category
Treatment - Drugs
2
Description
Intervention group 2 : Maintenance will achieve with 1 MAC of Isoflurane , O2 50% in air at 4 L.min and infusion of remifentanil 0.1 μg/kg/min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Hospital
Full name of responsible person
Dr Daryoush Moradi
Street address
Anesthesia department, Alzahra University Hospital, Soffeh Bulvar, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vce chancellor for research of Isfahan University of Medical Sciense
Full name of responsible person
dr Mehdi Nematbakhsh
Street address
Research daeputy, Isfahan university of medical science-Hezarjrib Street-Isfahan-Iranf
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vce chancellor for research of Isfahan University of Medical Sciense
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Daryoush Moradi
Position
Assistant Professor of Anesthesia and Critical care
Other areas of specialty/work
Street address
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjrib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3668 0042
Fax
Email
dmoradi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Daryoush Moradi
Position
Assistant Professor of Anesthesia and Critical Care
Other areas of specialty/work
Street address
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjrib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3668 0042
Fax
Email
dmoradi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciense
Full name of responsible person
Daryoush Moradi
Position
Assisstant Professor of Anesthesia and Critical Care
Other areas of specialty/work
Street address
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjrib street, Isfahan esthesia and critical care
City
Isfahan
Postal code
8174675731
Phone
+98 31 3668 0042
Fax
+98 36684510
Email
dmoradi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)