Aim:Compare the frequency of postoperative nausea and vomiting (PONV) in patients undergoing cataract surgery in two groups :receiving 30% and 80% of oxygen during the operation.This is a double-blind randomized clinical trial without control of placebo,with inclusion criteria:All patients 40-70 years old ; ASA(American Society of Anesthesiologists) Class 1,2 and exclusion criteria: history of postoperative nausea and vomiting; motion sickness; obesity; pregnancy; breastfeeding; smoking; use of antiemetic drugs within 24 hours prior to surgery; migrain headache; duration of surgery more than an houre; diabetes melitus.In this study two hundred patients candidate for cataract surgery( Under general anesthesia) were randomly divided into two groups: group A(The recipient of 30 percent oxygen) and group B (The recipient of 80 percent supplemental oxygen).We compared the frequency of nausea and vomiting after surgery and its incidence in the two groups discussed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020126300N1
Registration date:2016-09-07, 1395/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-07, 1395/06/17
Registrant information
Name
Mahshid Ashrafzadeh
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 0946
Email address
mahshidashrafzadeh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplemental oxygen during the procedure on postoperative nausea and vomiting in patients undergoing cataract surgery
Public title
The effect of oxygen on nausea and vomiting
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:All patients 40-70 years old; ASA(American Society of Anesthesiologists) Class 1,2 Exclusion criteria:History of postoperative nausea and vomiting; motion sickness; obesity; pregnancy; breastfeeding; smoking; use of antiemetic drugs within 24 hours prior to surgery; migrain headache; duration of the surgery more than one houre; diabetes melitus.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences,Doctor Hesabi Sq.
City
Zahedan
Postal code
9816743463
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.zaums.rbc.1394.196
Health conditions studied
1
Description of health condition studied
postoperative nausea and vomiting
ICD-10 code
k91.9
ICD-10 code description
Postprocedural disorder of digestive system, unspecified
2
Description of health condition studied
cataract
ICD-10 code
H26.9
ICD-10 code description
cataract,unspecified
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
during the first 6 hours after surgery
Method of measurement
Observation and assessment with statistical methods
Secondary outcomes
empty
Intervention groups
1
Description
Group A: Receiving 30 percent oxygen during surgery
Category
Treatment - Other
2
Description
Group B: Receiving 80 percent oxygen during surgery
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Subspecialty Ophthalmology Hospital
Full name of responsible person
Mahshid Ashrafzadeh
Street address
Shahid Motahhari Boulevard,Azadi squar
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery for Research and Information Technology,Zahedan University of Medical Sciences
Full name of responsible person
Doctor Rafighdoost Hooshang
Street address
Zahedan University of Medical Sciences,Doctor Hesabi sq.
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery for Research and Information Technology,Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahshid Ashrafzadeh
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences,Doctor Hesabi square
City
Zahedan
Postal code
Phone
+98 54 3348 0946
Fax
Email
mahshidashrafzadeh@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciense
Full name of responsible person
Doctor Rahat Dahmardeh Alireza
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Zahedan University of Medical Sciense,Doctor Hesabi sq.
City
Zahedan
Postal code
Phone
+98 54 3342 5758
Fax
Email
Dr.dahmardeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan university of Medical Sciences
Full name of responsible person
Mahshid Ashrafzadeh
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
mahshidashrafzadeh@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)