The effect of supplemental oxygen therapy on the incidence and severity of complications after cesarean surgery with spinal anesthesia method in educational and medical center of Besat-Sanandaj
Objectine: to evaluate the effect of supplemental oxygen therapy on the incidence and severity of complications after cesarean surgery. Study population: women with cesarean surgery with spinal anesthesia method in Besat hospital of Sanandaj. Methods: 120 samples will be assigned randomly to intervention and control groups. Vital signs and arterial blood oxygen saturation level are recorded before induction of anesthesia and 5 and 30 minutes before the completion of anesthesia and then in 1-5-10-20 and 30 minutes and every one hour to six hrs after the completion of anesthesia. For the intervention group, oxygen 60% equivalent to 10 liters per minute will be used during anesthesia and surgery and after surgery in recovery section for 6 hours using the Venturi mask. In control group routine care will be performed (oxygen 30% equivalent to 3-5 liters per minute). Surgical wound will be evaluated by ASEPSIS INDEX at the time of discharge and 14 days later. (ASEPSIS INDEX: A, additional treatment; S, serous discharge; E, erythema; P, purulent exudates; S, separation of deep tissue; I, isolation of bacteria; and S, stay as inpatient for> 14 days). Incidence of nausea and vomiting will be recorded by questionnaire and severity of pain and nausea will be recorded by standard VAS during surgery and 24 hours after surgery in recovery section.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806192440N1
Registration date:2010-02-20, 1388/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-20, 1388/12/01
Registrant information
Name
Jamal Seidy
Name of organization / entity
Nursing and midwife college, Kurdestan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1661 0095
Email address
jamal.seidy@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Affairs Research and Information Management of Kurdistan University of medical sciences
Expected recruitment start date
2009-11-21, 1388/08/30
Expected recruitment end date
2010-02-19, 1388/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplemental oxygen therapy on the incidence and severity of complications after cesarean surgery with spinal anesthesia method in educational and medical center of Besat-Sanandaj
Public title
The effect of supplemental oxygen therapy on the rate of complications after cesarean surgery with Spinal anesthesia method in Besat hospital of Sanandaj
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: cesarean section operation under spinal anesthesia, fasting around 6-8 hrs before surgery,
Exclusion criteria: gastrointestinal disease, history of middle ear infection and dizziness and moving illness, diabetes and blood pressure illness, smoking and alcohol consumption, using immunosuppressive, fever and infection before surgery, anesthesia and the irregular bleeding long too much, abnormal hemoglobin, receiving any drugs except antibiotics and analgesics up to six hours after surgery
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
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
Affairs Research and Information Management of Kurdestan university of medical sciences
Street address
Pasdaran st
City
Sanandaj
Postal code
6617713446
Approval date
1387-12-28, 769/01/-812
Ethics committee reference number
12093پ14پ
Health conditions studied
1
Description of health condition studied
the complications after caesarean surgery with the spinal anesthesia method
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
Incidence and severity of pain, nausia and vometing
Timepoint
Immediately after surgery, 6 hours and 24 hours after surgery
Method of measurement
questionnaire and standard VAS
Secondary outcomes
1
Description
Incidence and severity of surgery woud infection
Timepoint
24hours to 14days after cesarean surgery
Method of measurement
ASEPSIS index
Intervention groups
1
Description
oxygen 60% equivalent to 10 liters per minute will be used during anesthesia and surgery and after surgery in recovery section for 6 hours using the Venturi mask
Category
Treatment - Drugs
2
Description
In control group routine care will be performed (oxygen 30% equivalent to 3-5 liters per minute)
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Educatonal and medical center of Besat - opration room
Full name of responsible person
Dr Fariba Farhady far
Street address
Keshavars st.
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Affairs Research and Information Management, Kurdistan University of Medical sceinces
Full name of responsible person
Dr Ata alla Haydary
Street address
Kurdistan University of Medical sceinces
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Affairs Research and Information Management, Kurdistan University of Medical sceinces
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
Kurdestan universty of Medical sciences
Full name of responsible person
Jamal Seidy
Position
Member of scientific group of nursing college, Ms of operating room
Other areas of specialty/work
Street address
Kurdestan universty of Medical sciences, Pasdaran st.
City
Sanandaj
Postal code
6617713446
Phone
+98 87 1661 0095
Fax
+98 87 1666 0092
Email
jamal.seidy@muk.ac.ir ; jamal.seidi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdestan universty of Medical sciences
Full name of responsible person
Dr Fariba Farhadifar
Position
Faculty member - board specialized Maternity
Other areas of specialty/work
Street address
Kurdestan universty of Medical sciences, Pasdaran st.
City
Sanandaj
Postal code
6617713446
Phone
+98 87 1328 5910
Fax
+98 87 1666 4674
Email
Sima_Homa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Jamal Seidy
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)