Dexamethasone and Paracetamol for Nausea and Vomiting after C-Section

Prophylactic Effect of Different Doses of Intravenous Dexamethasone versus Paracetamol on Postoperative Nausea and Vomiting after Spinal Anesthesia for Elective Cesarean Section: A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240221061070N9

Enrollment

225

Registered

2025-11-29

Start date

2025-12-05

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Postoperative nausea and vomiting after cesarean section. Nausea and vomiting

Interventions

Intervention 1: Intervention group: This group will receive 2 mg of intravenous dexamethasone (dissolved in 2 ml of normal saline) administered slowly over 10 minutes, 10 minutes before the surgical i

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women with American Society of Anesthesiologists (ASA) physical status class II Aged 18 to 45 years Scheduled for elective cesarean section under spinal anesthesia

Exclusion criteria

Exclusion criteria: Cardiac, pulmonary, hepatic, or renal disease Psychological disorders Diabetes Mellitus Thyroid disorders History of alcohol or drug abuse Use of vasodilator drugs Need for blood transfusion during surgery Body temperature 37.5°C Receipt of labor analgesia

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative nausea and vomiting after cesarean section. Timepoint: Within the first 24 hours after the end of the surgical procedure. Method of measurement: Documentation of the presence or absence of any episode of nausea or vomiting by a blinded assessor.;Severity of nausea and vomiting. Timepoint: Within the first 24 hours after the end of the surgical procedure. Method of measurement: Assessment using a 4-point numerical scale (0: no symptoms, 1: mild nausea, 2: severe nausea, 3: vomiting, 4: severe vomiting).;Patient satisfaction level. Timepoint: 24 hours after the surgical procedure. Method of measurement: Direct questioning of the patient and recording responses based on a 5-point Likert scale (1: completely dissatisfied, 5: completely satisfied).	—

Measure

Time frame

Incidence of postoperative nausea and vomiting after cesarean section. Timepoint: Within the first 24 hours after the end of the surgical procedure. Method of measurement: Documentation of the presence or absence of any episode of nausea or vomiting by a blinded assessor.;Severity of nausea and vomiting. Timepoint: Within the first 24 hours after the end of the surgical procedure. Method of measurement: Assessment using a 4-point numerical scale (0: no symptoms, 1: mild nausea, 2: severe nausea, 3: vomiting, 4: severe vomiting).;Patient satisfaction level. Timepoint: 24 hours after the surgical procedure. Method of measurement: Direct questioning of the patient and recording responses based on a 5-point Likert scale (1: completely dissatisfied, 5: completely satisfied).

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Secondary

Measure	Time frame
Patient satisfaction regarding nausea and vomiting control. Timepoint: Within the first 24 hours after the end of surgery. Method of measurement: 5-point satisfaction questionnaire (from 1= Completely dissatisfied to 5= Very satisfied).;Need for rescue antiemetic medication (Ondansetron). Timepoint: Within the first 24 hours after the end of surgery. Method of measurement: Recording the number of patients who receive 4 mg intravenous ondansetron due to severe nausea or vomiting (Grade 3).;Changes in Blood Pressure. Timepoint: At 5, 15, 30, and 60 minutes after the administration of spinal anesthesia. Method of measurement: Non-invasive blood pressure monitor.;Changes in Heart Rate. Timepoint: At 5, 15, 30, and 60 minutes after the administration of spinal anesthesia. Method of measurement: Continuous electrocardiogram monitoring and pulse oximeter.;Incidence of drug-related adverse effects (Hypotension, Bradycardia, Skin rash, Headache). Timepoint: During surgery and within the first 24 hours after the end of surgery. Method of measurement: Checklist of adverse effects completed by a blinded observer.	—

Measure

Time frame

Patient satisfaction regarding nausea and vomiting control. Timepoint: Within the first 24 hours after the end of surgery. Method of measurement: 5-point satisfaction questionnaire (from 1= Completely dissatisfied to 5= Very satisfied).;Need for rescue antiemetic medication (Ondansetron). Timepoint: Within the first 24 hours after the end of surgery. Method of measurement: Recording the number of patients who receive 4 mg intravenous ondansetron due to severe nausea or vomiting (Grade 3).;Changes in Blood Pressure. Timepoint: At 5, 15, 30, and 60 minutes after the administration of spinal anesthesia. Method of measurement: Non-invasive blood pressure monitor.;Changes in Heart Rate. Timepoint: At 5, 15, 30, and 60 minutes after the administration of spinal anesthesia. Method of measurement: Continuous electrocardiogram monitoring and pulse oximeter.;Incidence of drug-related adverse effects (Hypotension, Bradycardia, Skin rash, Headache). Timepoint: During surgery and within the first 24 hours after the end of surgery. Method of measurement: Checklist of adverse effects completed by a blinded observer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMilad Masaeli

Esfahan University of Medical Sciences

drmilmas@gmail.com+98 31 3236 7001

Outcome results

None listed

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