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Comparison of administration of supplemental oxygen on nausea and vomiting in patients undergoing spinal anesthesia for elective cesarean section

Protocol summary

Summary
This clinical trial will be conducted to determine the effect of supplemental oxygen administration on nausea and vomiting, in patients undergoing elective cesarean section. 120 patients will be randomly assigned in study groups. Inclusion criteria will be elective cesarean section and fasting for 6-8 hours before and 6 hours after surgery and patients who need to general anesthesia or having sever vomiting, symptomatic gastrointestinal disease, motion sickness, dizziness, heart disease, cardiovascular and pulmonary disease, middle ear diseases, diabetes mellitus, infectious disease, fever, hypertension, smoking, alcohol consumption, immunosuppressive medications, bleeding and hemoglobin less than 10 mg/dl will be excluded. In control group patients will receive 3-5 liters per minute by oxygen masks, but in the intervention group during and after surgery and in recovery for 6 hours 10 liters per minute oxygen through masks will be given. The data collection tools are check list and questionnaire. Total incidence of nausea and vomiting and its severity according to VAS standard tools will be compared in study groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101125596N1
Registration date: 2011-07-12, 1390/04/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-12, 1390/04/21
Registrant information
Name
Nasrin Galehdar
Name of organization / entity
Lorestan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 66142099714
Email address
galehdar.n@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Lorestan University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of administration of supplemental oxygen on nausea and vomiting in patients undergoing spinal anesthesia for elective cesarean section
Public title
Effect of oxygen therapy on nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Elective cesarean section and fasting for 6-8 hours before and 6 hours after surgery. Exclusion criteria: Need to general anesthesia or having sever vomiting, symptomatic gastrointestinal disease, motion sickness, dizziness, heart disease, cardiovascular and pulmonary disease, middle ear diseases, diabetes mellitus, infectious disease, fever, hypertension, smoking, alcohol consumption, immunosuppressive medications, bleeding, hemoglobin less than 10 mg dl and another medications other antibiotics.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences and Health Services
Street address
Pardiss complex
City
Khoramabad
Postal code
Approval date
2011-02-22, 1389/12/03
Ethics committee reference number
1182

Health conditions studied

1

Description of health condition studied
Complications of anaesthesia during labour and delivery
ICD-10 code
O74.8
ICD-10 code description
Other complications of anaesthesia during labour and delivery

Primary outcomes

1

Description
Vomiting - Nausia
Timepoint
During six hours after surgery
Method of measurement
Question and visual analoge scale

Secondary outcomes

1

Description
Alternation of level and severity of nausia-alternation of level and severity of vomiting
Timepoint
Before surgery then every half hours until 6 hours after surgery
Method of measurement
Question and visual analog scale

Intervention groups

1

Description
Control group: 3-5 liter/min oxygen with a regular mask during surgery and 6 hours after surgery
Category
Prevention

2

Description
Intervetional group: oxygen 10 liter/min by ventury mask during surgery and until 6 hours after surgery
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Assali Hospital
Full name of responsible person
Galehdar Nasrin
Street address
Palestin Ally
City
Khoramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences and Health Services
Full name of responsible person
Dr. Kaeidy MH
Street address
Lorestan University of Medical Sciences and Health Services - pardiss complex
City
Khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences and Health Services
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
Lorestan University of Medical Sciences and Health Services
Full name of responsible person
Galehdar Nasrin
Position
MS in Nursing Education-Faculty Member-Instractor
Other areas of specialty/work
Street address
Paramedical Faculty, Goldasht
City
Khoramabad
Postal code
6819789741
Phone
+98 66042009971
Fax
+98 66 1422 0030
Email
galehdar_nas@yahoo.co.in; galehdar.n@lums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences and Health Services
Full name of responsible person
Galehdar Nasrin
Position
Faculty Member
Other areas of specialty/work
Street address
Paramedical Faculty
City
Khoramabad
Postal code
6819789741
Phone
+98 66 1420 9971
Fax
+98 66 1422 0030
Email
Galehdar_nas@yahoo.co.in; galehdar.n@lums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences and Health Services
Full name of responsible person
Galehdar Nasrin
Position
Instractor
Other areas of specialty/work
Street address
Paramedical Faculty
City
Khoramabad
Postal code
6819789741
Phone
+98 66 1420 9971
Fax
+98 66 1422 0030
Email
galehdar_nas@yahoo.co.in
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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