The aim of this research is to determine the effect of fentanyl (agonist) versus buprenorphine (agonist-antagonist) on pupil size in cataract surgery. All patients who are candidates for cataract surgery under general anaesthesia (GA) could be enrolled into this study. Exclusion criteria: Any situation that makes GA difficult or make pupil size measurement difficult (phaco-emulsification, glaucoma, addiction and history of previous surgery). Sample size is 30 in each group (case and control). The intervention in the case group is injection of buprenorphine 0/3 mcg/kg instead of fentanyl (1mcg/kg). The pupil will be sized pre-induction and 5 minutes after injection of the drug.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008211936N4
Registration date:2010-09-11, 1389/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-11, 1389/06/20
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2010-08-22, 1389/05/31
Expected recruitment end date
2010-10-22, 1389/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fentanyl versus Buprenorphine on Pupil Size in Cataract Surgery
Public title
The Effect of Fentanyl versus Buprenorphine on Pupil Size in Cataract Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients who are candidates for cataract surgery under general anaesthesia (GA) could be enrolled into this study. Exclusion criteria: Any situation that makes GA difficult or make pupil size measurement difficult (phaco-emulsification, glaucoma, addiction and history of previous surgery).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Siraf avenue
City
Bushehr
Postal code
Approval date
2010-07-01, 1389/04/10
Ethics committee reference number
10578/3/18/20/ب پ
Health conditions studied
1
Description of health condition studied
puil size response to opioid
ICD-10 code
--
ICD-10 code description
---
Primary outcomes
1
Description
Pupil diameter
Timepoint
Before induction anf 5 minutes after induction
Method of measurement
Hand holed papilometer
Secondary outcomes
1
Description
Hemodynamic changes
Timepoint
Continuously measured from induction of Anaesthesia till discharge (24 hours)
Method of measurement
questionnaire
2
Description
Shivering
Timepoint
The time at recovery
Method of measurement
observation
3
Description
Discharge from recovery
Timepoint
At the time of discharge
Method of measurement
questionnaire
Intervention groups
1
Description
In control group size of the pupil will be measured twice by the surgeon who is unaware of the induction regime. The induction drug in this group is STP 3 g/kg plus atracurium 0.2 mg /kg plus fentanyl 2 mcg/kg. After induction patient will be ventilated by mask and then ventilation will continue by LMA until the end of surgery. Pupil size will be measured 4 minute later by the same surgeon.
Category
Prevention
2
Description
In intervention group size of the pupil will be measured twice by the surgeon who is unaware of the induction regime. The induction drug in this group is STP 3 g/kg plus atracurium 0.2 mg /kg plus buperonorphinel 0.3 mcg/kg. After induction patient will be ventilated by mask and then ventilation will continue by LMA until the end of surgery. Pupil size will be measured 4 minute later by the same surgeon
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fateme Zahra hospital
Full name of responsible person
Dr Najafi and Dr Akrami
Street address
Fateme Zahra hospital, Siraf Avenue
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Najafi, and Dr Akrami
Street address
Siraf Avenue
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr.Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Siraf Avenue
City
Bushehr
Postal code
Phone
+98 77 1252 2081
Fax
Email
arna566@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr.Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Siraf Avenue
City
Bushehr
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)