Comparison of the effect of intravenous ondansetron and granistron with placebo on hemodynamic variables and the need for ephedrine in women candidates for cesarean section under spinal anesthesia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100102002963N35

Enrollment

Registered

2022-03-19

Start date

2022-05-05

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Hemodynamic variables and hypotension after spinal anesthesia in the women undergoing cesarean section. Postprocedural hypotension

Interventions

Intervention 1: Intervention group 1: In this group, granisetron at a dose of 3 mg equivalent to 3 ml is injected slow intravenously and once immediately before spinal anesthesia to eligible patients.

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 20-35 years old women with term pregnancy American Society of Anesthesia (ASA) physical status I Non- emergency cesarean delivery Spinal anesthesia

Exclusion criteria

Exclusion criteria: dissatisfaction with the study diabetes preeclampsia and eclampsia severe heart, lung, kidney and liver disease drug addiction

Design outcomes

Primary

Measure	Time frame
Systolic blood pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.;Diastolic Blood Pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.;Mean Arterial Pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.;Heart Rate. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.;Drop in systolic blood pressure below 90 mm Hg. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.	—

Measure

Time frame

Systolic blood pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.;Diastolic Blood Pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.;Mean Arterial Pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.;Heart Rate. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.;Drop in systolic blood pressure below 90 mm Hg. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes. Method of measurement: Using monitoring device.

—

Secondary

Measure	Time frame
Bradycardia(drop in heart rate below 50/ min). Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes during recovery. Method of measurement: Using monitoring device.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Shekoufeh Behdad

Yazd University of Medical Sciences

drbehdad@ssu.ac.ir0098 35 8231932

Outcome results

None listed

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