Investigating the effect of Ondansetron on nausea and itching caused by spinal Fentanyl injection

Comparison of the effect of prophylactic injection of doses of 4 and 8 mg of intravenous Ondansetron on nausea and itching after spinal injection of Fentanyl in spinal anesthesia, in lower limb orthopedic surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160307026950N47

Enrollment

Registered

2022-10-12

Start date

2022-09-23

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Spinal anesthesia.

Interventions

Intervention 1: Intervention group A: In this group of eligible patients, after receiving 5 ml/kg of Crystalloid fluid, they are placed on the surgical bed and cardiorespiratory monitoring is connecte

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients 18 to 65 years old Anesthesia class I and II according to ASA criteria Candidate for lower limb surgery under spinal anesthesia Informed consent to enter the study

Exclusion criteria

Exclusion criteria: History of smoking, drug and psychedelic addiction Allergy to any anesthetic drugs, Ondansetron and fentanyl History of coagulation disorders High ICP Pregnancy or breastfeeding Skin infection at the injection site Anti-nausea use in the last 24 hours

Design outcomes

Primary

Measure	Time frame
Severity of nausea. Timepoint: Every 5 minutes after spinal until 15 minutes and then every 15 minutes until the end of the 4th hour. Method of measurement: Nausea and vomiting severity behavioral scale questionnaire.;Itching scale. Timepoint: Every 5 minutes after spinal until 15 minutes and then every 15 minutes until the end of the 4th hour. Method of measurement: Itching severity scale questionnaire.	—

Measure

Time frame

Severity of nausea. Timepoint: Every 5 minutes after spinal until 15 minutes and then every 15 minutes until the end of the 4th hour. Method of measurement: Nausea and vomiting severity behavioral scale questionnaire.;Itching scale. Timepoint: Every 5 minutes after spinal until 15 minutes and then every 15 minutes until the end of the 4th hour. Method of measurement: Itching severity scale questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepide Hasani

Esfahan University of Medical Sciences

sepideh.hassani@yandex.com+98 31 3620 2020

Outcome results

None listed

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