Preventive effect of intravenous Ondansetron and Paracetamol on Shivering

Phase 3

Recruiting

• Conditions: Shivering.

• Registration Number: IRCT20231229060566N1
• Lead Sponsor: Myself fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 99

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.