Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06930456

Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension

The purpose of this study is to assess and contrast the effectiveness of intravenous ondansetron and intravenous hydrocortisone in avoiding spinal anesthesia-induced hypotension.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Post Spinal Anaesthesia Hypotension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Port Said Hospital

Port Said, Port Said Governorate, Egypt

About this study

According to the medication investigated in this study, patients will be divided into three equal groups (40 each). Patients will receive one of the following 15 minutes before spinal anesthesia:

  • Hydrocortisone 100 mg (H group)
  • Ondansetron 8 mg (O group)
  • An identical volume of sterile distilled water (Control group) (C group).

Spinal anesthesia will be performed under complete aseptic conditions with the patient seated, a 25-gauge Quincke spinal needle is used to administer 3.5 ml of a 0.5% hyperbaric bupivacaine together with 25 micrograms of fentanyl at the L3-L4 or L4-L5 level.

Patients will lie supine with slight head elevation after the intrathecal injection is finished. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 30 min during which the patient remains in the supine position with no application of torniquet.

If the MAP drops by 20% below baseline or the systolic blood pressure falls below 90 mmHg, hypotension is recorded and will be treated with intravenous incremental doses of 5 mg ephedrine.

If the heart rate drops below 50 beats per minute, bradycardia is recorded, and atropine 0.5 mg will be administered intravenously. If ephedrine or atropine were used, only data from before their administration would be analyzed. The doses of ephedrine and atropine needed will be recorded.

Nausea, vomiting and shivering will be recorded when occur till the end of operation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I and II (physical status according to American Society of Anesthesiologists).
  • Patients aged 21 years or more.
  • Either sex.
  • Abdominal and lower limb operations.

Exclusion criteria

  • Patient refusal.
  • hemodynamic instability
  • Hematological diseases, bleeding or coagulation abnormality.
  • Local skin infection and sepsis at site of spinal anesthesia
  • neuromuscular diseases (as myopathies, myasthenia gravies…)
  • Preexisting neurological deficit or psychiatric diseases.
  • Known intolerance to the study drugs.
  • patients already receiving any of the study drugs.
  • diabetic patient.

Treatment and study plan

Hydrocortisone

Drug

A deidentified syringe (10 mL) containing 100 mg hydrocortisone will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 6 readings during which the patient remains in the supine position with no application of torniquet.

ondansetron

Drug

A deidentified syringe (10 mL) containing 8 mg ondansetron will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 6 readings during which the patient remains in the supine position with no application of torniquet.

Placebo

Drug

A deidentified syringe (10 mL) containing sterile distilled water for intravenous injection will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 6 readings during which the patient remains in the supine position with no application of torniquet.

Primary outcomes

  1. hypotension

    Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

    The percentage of patients experiencing hypotension (a 20% decrease of the basal mean arterial blood pressure or systolic blood pressure less than 90 mmHg) at any point in the first thirty-minute period following spinal anesthetic induction

Secondary outcomes

  1. bradycardia

    Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

    The percentage of patients experiencing bradycardia (HR less than 50 beat/min) at any point in the first thirty-minute period following spinal anesthesia.

  2. requirement of atropine or ephedrine

    Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

    The proportion of those who require atropine or ephedrine for management of bradycardia or hypotension

  3. Doses of administered atropine and ephedrine

    Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

    Doses of administered atropine and ephedrine

  4. nausea and vomiting

    Time frame: after subarachnoid injection till the end of operation

    Incidence of post spinal nausea and vomiting till the end of operation

  5. shivering

    Time frame: after subarachnoid injection till the end of operation

    Incidence of post spinal shivering till the end of operation

  6. blood pressure and heart rate variations

    Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

    Variations in blood pressure and Heart Rate (HR).

Sponsors and collaborators

Lead sponsor

Nada kamel Elgamal

Other

Registry information

Official study title

Intravenous Hydrocortisone Versus Ondansetron in Prevention of Post Spinal Anesthesia Hypotension in Elective Surgeries

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.