The main goal of today’s ophtalmosurgery is to control Anxiety, painless procedure and also unwanted movements. The aim of this study was centered on comparison the sedative and hemodynamic effect and side effects of remifentanil and propofol in senile cataract surgeries for optimal drug selection. We performed a prospective, randomized study comparing the efficacy and safety of remifentanil and propofol for conscious sedation during eye cataract surgery. 60 Patients were assigned to receive remifentanil or Propofol in two groups accidentally, each contained 30 subjects. Our Inclusion crietrie was ASA physical status 2,3; Male or female age≥65 ;No Alergic Reaction to Drug ;No Drug abuse; No smoker and our exclusion crieteria was hypoxia; nausea andvomiting. In R (remifentanil) group, patients sedated with bolus doses of 0.5 µg/kg, and maintenance dose of 0.05 µg/kg/min. In P (propofol) group, patients sedated with bolus doses of 0.25 µg/kg and maintenance dose of 25 µg/kg/min. Hemodynamic responses, Oxygen blood level, sedation level and drug side effects were measured at base time and every 10 min till end of operation (OP).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111268201N1
Registration date:2012-04-14, 1391/01/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-14, 1391/01/26
Registrant information
Name
Reza Tarjoman Porshokoh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 3556
Email address
r_tarjoman@irimc.org
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the sedative effect of Remifentanil and Propofol in Senile Cataract Surgeries under Regional Block
Public title
Sedative effect of Remifentanil in Senile Cataract Surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA physical status 2,3; Male or female age≥65 ; No Allergic Reaction to Drug; No Drug abuse; No smoking. Exclusion criteria: hypoxia; nausea; vomiting.
Age
From 65 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Hemmat Pardis, next to Milad Hospital, Hemmat highway
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
42121
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Senile incipient cataract
Primary outcomes
1
Description
O2 saturation
Timepoint
During intravenous sedation
Method of measurement
Pulseoximeter
2
Description
Sedation score
Timepoint
Before regional block and every 10 minutes therafter until the end of operation
Method of measurement
MOAA/SS (Modified observer's assessment of alertness/sedation)
3
Description
Blood pressure
Timepoint
During intravenous sedation
Method of measurement
By non-invasive blood pressure measuring
4
Description
Heart rate
Timepoint
During intravenus sedation
Method of measurement
ECG
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
During intravenous sedation
Method of measurement
Observe
2
Description
Bradycardia
Timepoint
during intravenous sedation
Method of measurement
Electrocardiogram (ECG)
3
Description
Apnea
Timepoint
during intravenous sedation
Method of measurement
Respiratoty Rate
Intervention groups
1
Description
Control group: with bolus doses of 0.25 µg/kg and maintenance dose of 25 µg/kg/min
Category
Treatment - Drugs
2
Description
Intervention group: with bolus doses of 0.5 µg/kg, and maintenance dose of 0.05 µg/kg/min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Pour-Sina st, 16 Azar ave, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Reza Tarjoman Porshokoh
Position
MD
Other areas of specialty/work
Street address
no. 91, 11th st, Amir-Abad st
City
Tehran
Postal code
Phone
+98 21 8833 3556
Fax
Email
r_tarjoman@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahzad Alimian
Position
MD
Other areas of specialty/work
Street address
Hazrat Rasool Hospital
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
mahzadalimian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Tarjoman Porshokoh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 8833 3556
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)