The effectiveness of ondansetron on pregnant women

The effectiveness of ondansetron on hemodynamic changes following spinal anesthesia in pregnant women and comparison with prehydration and prophylactic ephedrine

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015102813159N7

Enrollment

120

Registered

2016-01-21

Start date

2015-12-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

pregnant women. Other single delivery by caesarean section

Interventions

Intervention 1: Control group: 4 mg of placebo drugs 5 minutes before spinal anesthesia. Intervention 2: Intervention group 1: 4 mg of Ondansetron 5 minutes before spinal anesthesia. Intervention 3: I

Treatment - Drugs

Control group: 4 mg of placebo drugs 5 minutes before spinal anesthesia

Intervention group 1: 4 mg of Ondansetron 5 minutes before spinal anesthesia.

Intervention group 2: 25 mg of Ephedrine injection to the muscle 25 minutes before spinal anesthesia

Intervention group 3: 500 ml of Ringer 20 minutes before spinal anesthesia

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: ASA I and ASA II diseases; aged between 18 and 40 years; single or twin gestations; undergoing Cesarean section or spinal anaesthesia for emergency Caesarean; not using anti-migraine therapeutics, SSRI or MAO inhibitors; not being allergic to ondansetron; absence of psychological disorders; and not consuming drugs or alcohol. Exclusion criteria: Failure of spinal anesthesia; untreatable pain with 50 micrograms of fentanyl after the onset of surgery; bleeding more than expected (500 cc in single gestation and 1000 cc in twin gestations); numbness extending beyond the dermatome T4 level according to skin testing with needle point; need to expand incision during surgery due to the surgical complications; and having major complications during surgery.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Maternal blood pressure. Timepoint: Before and after anesthesia. Method of measurement: Clinical mercury Manometer; mmHg.	—

Secondary

Measure	Time frame
Maternal heart rate. Timepoint: Before and after anesthesia. Method of measurement: Monitoring Compact; in minuets.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Saber Ranjbar

Ghaem Hospital

sabermoghaddamm@mums.ac.ir+98 51 3801 2616

Outcome results

None listed

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