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Preventive effect of intravenous Ondansetron and Paracetamol on Shivering

Preventive effect of intravenous Ondansetron and Paracetamol on shivering after spinal anesthesia in cesarean section

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231229060566N1
Enrollment
99
Registered
2024-03-10
Start date
2024-03-10
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Shivering.

Interventions

Intervention 1: The first intervention group:Women aged 18-45 are candidates for elective cesarean section the recipient receives 15 mg/kg of Apotel in 100 cc of normal saline for 5 minutes before spi

Sponsors

Myself fund
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 18-45 years old ASA (American Society of Anesthesiologists) physical status I or II Gestational age = 37 weeks Planned elective caesarean section under spinal anesthesia

Exclusion criteria

Exclusion criteria: Contraindications for spinal anesthesia include: high ICP, coagulation disorders, use of anticoagulant drugs, infection at the site of spinal anesthesia History of allergy or intolerance to any of the studied drugs, use of other drugs that cause drug interactions. (such as opiates), history of significant medical or surgical conditions and use of misoprostol during surgery and other contraindications Cases of emergency caesarean section and cases that become complicated, such as cases that lead to hysterectomy

Design outcomes

Primary

MeasureTime frame
Shivering after spinal anesthesia. Timepoint: Before intervention, monitoring during surgery and during recovery. Method of measurement: Checklist for recording the grading of shivering. Grade zero: no tremors, grade one: hairs prickling, grade two: vasoconstriction of hairs or muscles in only one muscle group, grade three: muscle activity in more than one muscle group. which does not happen in a generalized way, grade four: tremor of the whole body.

Secondary

MeasureTime frame
Pain after spinal anesthesia. Timepoint: Before the intervention and during the entire recovery period. Method of measurement: Checklist for pain grading based on Visual Analogue Scale.;Systolic blood pressure. Timepoint: Before intervention, 5 minutes of surgery, 10 minutes of surgery, every minute that systolic pressure is less than 100 during surgery, upon entering recovery, every minute that systolic pressure is less than 100 in recovery. Method of measurement: Heart monitoring.;Heart rate. Timepoint: Before the intervention, 5 minutes of surgery, 10 minutes of surgery, every minute that the heart rate is below 60, upon entering recovery, every minute that the heart rate is below 60 during recovery. Method of measurement: Heart monitoring.;Nausea and vomiting. Timepoint: Before intervention, during surgery and recovery. Method of measurement: Check list.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Moradi

Bandare-abbas University of Medical Sciences

negin7697@gmail.com+98 76 3335 4058

Outcome results

None listed

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