Protocol summary

Summary
The aim of this study is to compare the effects of general anesthesia with ,Sevoflurane , Isoflurane and Propofol on the incidence of nausea and vomiting after cataract surgery. Inclusion criteria included patients 50 to 70 years and candidate for elective surgery cataract and exclusion criteria included a ,history of nausea and vomiting after general anesthesia ,history of motion sickness ,severe hypoxia during anesthesia ,prolonged anesthesia ,using ketamine drug ,atvmydat(during general anesthesia) Ranitidine ,Metoclopramide ,severe anxiety and severe obesity. In this study,150people of patients randomized and double blind ,divided into three groups of sevoflurane(50 people),isoflurane(50 people)and propofol(50people).to all patients before induction of general anesthesia per.kg,7cc serum ringer is infusion. 0.5 mg atrakvrym and 1.5 mcg mgr fentanyl are used for induction of anesthesia in all three groups of 3mg of sodium thiopental is used. In order to continue anesthesia in first group of 1/5mac sevoflurane and%50of oxygen and nitrogen oxide ,in second group of 1.5 isoflurane of propofol and %50 nitrogen oxide and oxygen, in third group of infusion of propofol and %50nitrogen oxide and oxygen are used. After surgery , patients of:1- no nausea,2-nausea expression in question,3-incidence of nausea ,4-nausea and vomiting associated ,in three round (recovery , 3 hours and 6 hours after surgery) are examined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201210035543N8
Registration date: 2012-11-17, 1391/08/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-11-17, 1391/08/27
Registrant information
Name
Saeide Heidari
Name of organization / entity
School nursing and midwifery, Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 1292 4521
Email address
sheidari@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of general anesthesia with Sevofluran, Isoflorane and Propofol in decreasing nausea and vomiting after surgery
Public title
Comparison the effect of general anesthesia with Sevofluran, Isoflorane and Propofol in decreasing nausea and vomiting after surgery
Purpose
Other
Inclusion/Exclusion criteria
Exclusion criteria :history of nausea and vomiting after general anesthesia; history of motion sickness;severe hypoxia during anesthesia prolonged anesthesia; using ketamine drugs atvmydat;ranitidine ;metoclopramide ;severe anxiety and severe obesity. Also, due to interference with the metabolism of isoflurane;Phenobarbital;phenytoin; ethanol and isoniazed.non-using of these drugs as well as other condition are considered for the study. Inclusion criteria, all patients 50 to 70 years admitted for cataract surgery to kamkar hospital.
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
N/A
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
Qom University of Medical Science
Street address
Qom University of Medical Science ,Lavasani st ,Qom
City
Qom
Postal code
3713649373
Approval date
2012-09-26, 1391/07/05
Ethics committee reference number
11235/34/پ

Health conditions studied

1

Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Nausea and vomiting
Timepoint
Recovery 3 hour and 6 hour after surgery
Method of measurement
Visual and questions

Secondary outcomes

1

Description
Blood pressure
Timepoint
Recovery 3 and 6 hour after surgery
Method of measurement
Monitoring

Intervention groups

1

Description
Group 1: before induction of general anesthesia, all patients per kilogram of body weight,7cc of ringers saline is infusion. 0.5 mg Atracurim and 1.5 µ/gr fentanyl used for induction of anesthesia in all three groups of 3mg of sodium thiopental is used. In order to continue anesthesia , in first group of 1.5 mac sevoflurane and %50 nitrogen oxide and oxygen is used
Category
Treatment - Drugs

2

Description
Group2: before induction of general anesthesia, all patients per kilogram of body weight,7cc of ringers saline is infusion. 0.5 mg Atracurim and 1.5 µ/gr fentanyl used for induction of anesthesia in all three groups of 3mg of sodium thiopental is used. In order to continue anesthesia , in second group of 1.5 mac isoflurane and %50 nitrogen oxide and oxygen is used
Category
Treatment - Drugs

3

Description
Group3: before induction of general anesthesia, all patients per kilogram of body weight,7cc of ringers saline is infusion. 0.5 mg Atracurim and 1.5 µ/gr fentanyl used for induction of anesthesia in all three groups of 3mg of sodium thiopental is used. In order to continue anesthesia , in third group of infusion of propofol and %50 nitrogen oxide and oxygen is used
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamkar hospital
Full name of responsible person
Dr.Mohammad Hossein Pishvaey
Street address
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Science
Full name of responsible person
Dr Alireza Koohpaei
Street address
Qom University of Medical Science ,Lavasani st ,Qom
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Science
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
Qom University of Medical Science
Full name of responsible person
Dr.Mohammad Hossein Pishvaey
Position
Phd Anesthesia
Other areas of specialty/work
Street address
Qom University of Medical Science
City
Qom
Postal code
Phone
+251 2923957
Fax
Email
mkoohbor68@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Science
Full name of responsible person
Dr.Mohammad Hossein Pishvaey
Position
Phd Anesthesia
Other areas of specialty/work
Street address
Qom University of Medical Science, Lavasani st ,Qom
City
Qom
Postal code
Phone
+98 25 1292 3957
Fax
Email
mkoohbor68@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Science
Full name of responsible person
Mohhammad Koohbar
Position
Anesthesiology expert
Other areas of specialty/work
Street address
Qom University of Medical Science
City
Qom
Postal code
Phone
+98 25 1292 3957
Fax
Email
mkoohbor68@yahoo.com
Web page address

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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