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Prevention of post spinal shivering by drugs

Comparing intravenous hydrocortisone versus ketamine on reducing of post spinal shivering in cesarean section

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016073110841N6
Enrollment
150
Registered
2016-09-14
Start date
2016-02-20
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

post spinal shivering. Complication of anaesthesia during labour and delivery, unspecified

Interventions

Intervention 1: After spinal anesthesia, in group A 2mg/kg hydrocortison (3ml),after clamping of umblical cord intravenously is injected. Intervention 2: After spinal anesthesia , in ketamine group ,0
Prevention
Placebo
After spinal anesthesia, in group A 2mg/kg hydrocortison (3ml),after clamping of umblical cord intravenously is injected.
After spinal anesthesia , in ketamine group ,0.5 mg/kg ketamine (3ml) after clamping of umblical cord intravenously is injected .
After spinal anesthesia, in control group 3ml normal salin , after clamping of umblical cord intravenously is injected.

Sponsors

Hamadan University of Medical Sciences, vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: pregnant women aged 18 -40 years old; ASA class 1&2; term pregnant patients (gestational age 36-40 weeks) and candidate for cesarean section under spinal anesthesia . Exclusion criteria: high risk pregnancy; multiple pregnancy; emergency cesarean section; pre-eclampsia & eclampsia; cardiovascular disease; respiratory disease; psychiatric disease; thyroid disease; diabetes melitus; long history of corticosteroids administration; hypertension; peptic ulcer; need to get blood products; temperature >38 c and contraindication of spinal anesthesia.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Systolic and diastolic blood presure. Timepoint: 1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery. Method of measurement: mmHg and by noninvasive automatic blood pressure monitoring.;Mean arterial pressure. Timepoint: 1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery. Method of measurement: mmHg and by noninvasive automatic blood pressure monitoring.;Heart Rate. Timepoint: 1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery. Method of measurement: Beat per minute and by ECG monitoring.;SPO2. Timepoint: 1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery. Method of measurement: Percent and by pulse oxymetry.;Tempreture. Timepoint: each 15 minutes until end of recovery. Method of measurement: degree and by medical oral termometer.;Frequency of shivering. Timepoint: during sergury and in recovery. Method of measurement: Observation.;Shiverig grading. Timepoint: during sergury and in recovery. Method of measurement: shivering score.;Consumption of pethidine. Timepoint: during sergury and in recovery. Method of measurement: mg and by observation.;Consumption ofephedrine. Timepoint: during sergury and in recovery. Method of measurement: mg and by observation.;Neonate APGAR. Timepoint: 1&5 minutes after birth. Method of measurement: APGAR Score.

Secondary

MeasureTime frame
Sedation score. Timepoint: 1-2-3-4-5-10-15-20-30-40-50-60 minutes after spinal anesthesia and 10-20 &30 minutes after arriving to recovery. Method of measurement: Ramsay score.;Hallocination. Timepoint: during surgery & recovery. Method of measurement: observation & interview.;Nausea & vomiting. Timepoint: during surgery. Method of measurement: observation & interview.;Nistagmus. Timepoint: during surgery & recovery. Method of measurement: Observation & Examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNahid Manouchehrian

Hamadan University of Medical Sciences, Fatemie Hospital

manuchehriann@gmail.com; manouchehrian@umsha.ac.ir+98 81 3827 7012

Outcome results

None listed

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