Ketamine and Ondansetron in post operative shivering in Cesarean Section

Comparison of the effectiveness of intravenous injection of Ketamine and Ondansetron in the prevention of the post-operative shivering in Cesarean Section under spinal anesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160307026950N20

Enrollment

121

Registered

2020-06-10

Start date

2020-06-21

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Postoperative shivering.

Interventions

Intervention 1: Intervention group A: Ondansetron is injected into the patient at a dose of 4 mg immediately after umbilical cord clamping. Intervention 2: Intervention Group A

Ketamine 0.5 mg per kilogram of body weight is injected into the patient immediately after clamping the umbilical cord. Intervention 3: Control group C: Normal saline as a placebo is injected into the

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Pregnant women are candidates for cesarean section Candidates for Spinal anesthesia ASA class I and II The patient's consent to participate in the study

Exclusion criteria

Exclusion criteria: History of high blood pressure History of mental illness History of heart problems with EF <60% History of kidney problems with GFR <60

Design outcomes

Primary

Measure	Time frame
Shivering. Timepoint: Every 15 minutes from the beginning of the operation until the end of recovery. Method of measurement: Using Mahajan and Grassi criteria.;Central temprature. Timepoint: Every 15 minutes from the beginning of the operation until the end of recovery. Method of measurement: Tympanic thermometer.;Peripheral Temprature. Timepoint: Every 15 minutes from the beginning of the operation until the end of recovery. Method of measurement: Skin thermometer.	—

Measure

Time frame

Shivering. Timepoint: Every 15 minutes from the beginning of the operation until the end of recovery. Method of measurement: Using Mahajan and Grassi criteria.;Central temprature. Timepoint: Every 15 minutes from the beginning of the operation until the end of recovery. Method of measurement: Tympanic thermometer.;Peripheral Temprature. Timepoint: Every 15 minutes from the beginning of the operation until the end of recovery. Method of measurement: Skin thermometer.

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Secondary

Measure	Time frame
Systolic Blood Pressure. Timepoint: Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Non invasive blood pressure measurement.;Diastolic Blood Pressure. Timepoint: Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Non invasive blood pressure measurement.;Mean Arterial Blood Pressure. Timepoint: Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Non invasive blood pressure measurement.;Heart Rate. Timepoint: From the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Heart monitoring device.;Oxygen saturation. Timepoint: From the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Pulse oximetry device.	—

Measure

Time frame

Systolic Blood Pressure. Timepoint: Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Non invasive blood pressure measurement.;Diastolic Blood Pressure. Timepoint: Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Non invasive blood pressure measurement.;Mean Arterial Blood Pressure. Timepoint: Every 15 minutes from the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Non invasive blood pressure measurement.;Heart Rate. Timepoint: From the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Heart monitoring device.;Oxygen saturation. Timepoint: From the beginning of the spinal anesthesia to the end of recovery. Method of measurement: Pulse oximetry device.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Shirini

Esfahan University of Medical Sciences

m.shirini98@yahoo.com+98 31 3652 0237

Outcome results

None listed

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