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Comparision of topical anesthesia and retrobulbar injection with intra venous sedation on Hemodynamic variability and patients satisfaction in cataract surgery (phaco technique)

Protocol summary

Summary
Patients between 50-90 years old and with ASA class I-III that candidate for Cataract surgery( Phaco technique) in random fixed block include in study and divides two group. The both group receiving IV Sedation at mixture of midazolam 0.5-1 mg and fentayl 0.5-1 mic/kg. First group take retrobulbar block with injection of 2 cc lidocain 2% and Hyaluronidase 1/15000.Second group in Topical anesthesia with Tetracaine 5% , 2-3 drops every 5 minute, maximum 3 times. In during the surgery is continuing monitoring of(Electrocardiography) ECG( level II), BP( blood pressure),O2 saturation and nasal canula with Oxigen, 5 liter/min .Every 5 minutes, HR( Heat rate),SBP( systolic blood pressure),DBP( diastolic blood pressure),MAP( mean artherial pressure),O2 Sat and every 15 minute VAS score and satisfaction score by anesthesiologist assistant is recorded.Time of surgery is 30-43 minutes, if the time of surgery prolonged ( more than 60 minutes) or Leads to general anesthesia patients exclude of this study. Hemodynamic variations, analgesia and patient satisfaction in this study, are two objectives .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013122815963N1
Registration date: 2014-02-05, 1392/11/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-02-05, 1392/11/16
Registrant information
Name
Soudabeh Haddadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13332383068
Email address
so_haddadi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2014-09-11, 1393/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of topical anesthesia and retrobulbar injection with intra venous sedation on Hemodynamic variability and patients satisfaction in cataract surgery (phaco technique)
Public title
Anesthesia in cataract surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:Patients candidates for elective cataract surgery phaco technique class ASA I, II, III exclusion criteria:The time of surgery prolonged ( more than 60 minutes) or Leads to general anesthesia
Age
From 50 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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
shahid Beheshti Boulvard
City
rasht
Postal code
4193893345
Approval date
2013-12-07, 1392/09/16
Ethics committee reference number
1920341313

Health conditions studied

1

Description of health condition studied
Cataract
ICD-10 code
H18.8
ICD-10 code description
Other specified disorders of cornea

Primary outcomes

1

Description
blood pressure
Timepoint
every 5 minutes during the surgery up to 60 minutes
Method of measurement
Saadat company,digitaly

2

Description
heart rate
Timepoint
every 5 minutes during the surgery up to 60 minutes
Method of measurement
Saadat company,digitaly

Secondary outcomes

1

Description
pain
Timepoint
every 15 minutes up to 60 minutes
Method of measurement
Vas(visual analogue scale)

Intervention groups

1

Description
First group take retrobulbar block with injection of 2 cc lidocain 2% and Hyaloronidaz 1/15000.
Category
Treatment - Drugs

2

Description
Second group in Topical anesthesia with Tetracaine 5% , 2-3 drops every 5 minute, maximum 3 times.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Soudabeh Haddadi
Street address
17 Shahrivar Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abdolrasool Sobhani
Street address
Shahid beheshti Highway
City
Rasht
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 of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Soudabeh Haddadi
Position
Anesthesiologist/Assistant proffessor
Other areas of specialty/work
Street address
Amiralmomenin Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 1223 8306
Fax
+98 13 1222 7409
Email
arcguilan1392@gmail.com; so_haddadi@yahoo.com
Web page address
gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Soudabeh Haddadi
Position
Anesthesiologist/Assistant proffessor
Other areas of specialty/work
Street address
Amiralmomenin Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 1223 8306
Fax
+98 13 1222 7409
Email
ARCguilan1392@gmail.com; so_haddadi@yahoo.com
Web page address
gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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