Objective: Spinal anesthesia is used for cesarean section. When the parturient is anxious, may affect the cesarean process. We designed this study to determine anxiolytic effective of nitrous oxide (N2O) in women undergoing cesarean section under spinal anesthesia. Design of study: we present a randomized double blind clinical trial on 56 primygravid 18-45 years old parturients undergoing cesarean section under spinal anesthesiain, 1388. 28 of patients received 50% N2O in O2 via face mask and control group received pure O2 during surgery. In six special time before and during the surgery (preoperation, spinal injection, skin incision, uterine incision, birth time and recovery time) they were evaluated for anxiety and pain VAS. In addition the ephedrine dose used during the surgery, newborns apgar score and presence of amnesia, nausea and vomiting were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091510841N1
Registration date:2012-10-24, 1391/08/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-24, 1391/08/03
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical effects of inhalational nitrous oxide 50% on childbirth anxiety in cesarean section under spinal anesthesia
Public title
Anxiolytic effect of N2O
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: primigravid patients; 18-45 years old; educated; scheduled for cesarean section under spinal anesthesia. Exclusion criteria: Pre-eclampsia & Eclampsia; Vavular Heart Disease; Respiratory Disease; Previous Nausea &Vomiting; Ear Disease or Surgery; Increased ICP; Anemia; Shock; Patient refusal.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University Of Medical Sciences
Street address
Hamadan University Of Medical Science, Medicine School, Mahdie Street
City
Hamadan
Postal code
Approval date
2008-11-22, 1387/09/02
Ethics committee reference number
16/35/9/116444
Health conditions studied
1
Description of health condition studied
Childbirth Anxiety under spinal anesthesia
ICD-10 code
F53
ICD-10 code description
Mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Anxiety Level
Timepoint
Befor spinal anesthesia and During spinal anesthesia, Skin Incision, Uterine Incision, Birth Time, Recovery Time
Method of measurement
Anxiety VAS
Secondary outcomes
1
Description
Heart rate
Timepoint
every 5 minutes up to 15 minutes and every 15 minutes up to the end of the operation.
Method of measurement
Puls oximetry
2
Description
Hallucination
Timepoint
During Surgery & Recovery Time
Method of measurement
Observation
3
Description
Nausea & Vomiting
Timepoint
During operation & Recovery Time
Method of measurement
Observation
4
Description
Systoilic & Diastolic Blood Pressure
Timepoint
every 5 minutes up to 15 minutes and every 15 minutes up to the end of the operation.
Method of measurement
Non Invasive Blood Pressure Monitoring
Intervention groups
1
Description
Intervention group: inhalation N2O%50 with oxygen by anesthesia mask. Patients received O2 & N2O %50 from 3 minutes before spinal anesthesia until birth time.
Category
Treatment - Drugs
2
Description
Control group: inhalation oxygen %100 by anesthesia mask. Patients received O2 %100 from 3 minutes before spinal anesthesia until birth.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemy Hospital
Full name of responsible person
Nahid Manouchehrian, Anesthesiologist, Assistant Professor of Hamadan University Of Medical Sciences
Street address
Fatemy Hospital, Mahdie Street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University Of Medical Science, Vice chancellor for research
Full name of responsible person
Dr.Tavilany
Street address
School Medicine, Mahdie street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University Of Medical Science, Vice chancellor for research
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
Hamadan University Of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Anesthesiologist, Assistant profesore of Anesthesiology