🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Egypt / NCT06930456
Enrolling by invitation Not applicable

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

NCT06930456 · tracked via the Priya Life Science Egypt tracker
Sponsor
Nada kamel Elgamal
Phase
Not applicable
Started
2024-03-01
Last updated
2025-04-16

Condition(s) studied

Post Spinal Anaesthesia Hypotension

Investigational drug(s) / intervention(s)

hydrocortisone →ondansetron →Placebo

hydrocortisone: 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: 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: 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.

Study summary

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

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. ASA I and II (physical status according to American Society of Anesthesiologists). 2. Patients aged 21 years or more. 3. Either sex. 4. Abdominal and lower limb operations. Exclusion Criteria: 1. Patient refusal. 2. hemodynamic instability 3. Hematological diseases, bleeding or coagulation abnormality. 4. Local skin infection and sepsis at site of spinal anesthesia 5. neuromuscular diseases (as myopathies, myasthenia gravies…) 6. Preexisting neurological deficit or psychiatric diseases. 7. Known intolerance to the study drugs. 8. patients already receiving any of the study drugs. 9. diabetic patient.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Port Said Hospital Port Said Port Said Governorate

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06930456 on ClinicalTrials.gov ↗ ← All trials in Egypt