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Anxiolytic effect of N2O

Clinical effects of inhalational nitrous oxide 50% on childbirth anxiety in cesarean section under spinal anesthesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012091510841N1
Enrollment
56
Registered
2012-10-24
Start date
2009-03-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth Anxiety under spinal anesthesia. Mental and behavioural disorders associated with the puerperium, not elsewhere classified

Interventions

Intervention 1: Intervention group: inhalation N2O%50 with oxygen by anesthesia mask. Patients received O2 & N2O %50 from 3 minutes before spinal anesthesia until birth time. Intervention 2: Control g
Treatment - Drugs
Placebo
Intervention group: inhalation N2O%50 with oxygen by anesthesia mask. Patients received O2 & N2O %50 from 3 minutes before spinal anesthesia until birth time.
Control group: inhalation oxygen %100 by anesthesia mask. Patients received O2 %100 from 3 minutes before spinal anesthesia until birth.

Sponsors

Hamadan University Of Medical Science, Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Anxiety Level. Timepoint: Befor spinal anesthesia and During spinal anesthesia, Skin Incision, Uterine Incision, Birth Time, Recovery Time. Method of measurement: Anxiety VAS.

Secondary

MeasureTime frame
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.;Hallucination. Timepoint: During Surgery & Recovery Time. Method of measurement: Observation.;Nausea & Vomiting. Timepoint: During operation & Recovery Time. Method of measurement: Observation.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNahid Manouchehrian

Hamadan University Of Medical Sciences

manouchehrian@umsha.ac.ir+98 81 1827 7012

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026