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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Post Spinal Anaesthesia Hypotension
• Intervention / Treatment: Drug: hydrocortisone; Drug: ondansetron; Drug: Placebo

Detailed Description

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:

1. Hydrocortisone 100 mg (H group)
2. Ondansetron 8 mg (O group)
3. 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Port Said, Egypt
    • Port Said Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hydrocortisone (H) group; As in intervention description	Drug: 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.
Active Comparator: Ondansetron (O) group; As in intervention description	Drug: 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 Comparator: control (C) group; As in intervention description	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypotension	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	5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bradycardia	The percentage of patients experiencing bradycardia (HR less than 50 beat/min) at any point in the first thirty-minute period following spinal anesthesia.	5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
requirement of atropine or ephedrine	The proportion of those who require atropine or ephedrine for management of bradycardia or hypotension	5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
Doses of administered atropine and ephedrine	Doses of administered atropine and ephedrine	5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
nausea and vomiting	Incidence of post spinal nausea and vomiting till the end of operation	after subarachnoid injection till the end of operation
shivering	Incidence of post spinal shivering till the end of operation	after subarachnoid injection till the end of operation
blood pressure and heart rate variations	Variations in blood pressure and Heart Rate (HR).	5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

Collaborators and Investigators

• Sponsor: Nada kamel Elgamal
• Investigators: Study Chair: Magdy Ali Omera, prof. of Anesthesia and ICU, Port Said University, Faculty of Medicine, Department of Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Dermatologic Agents; Neurotransmitter Agents; Antipruritics; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Ondansetron; Hydrocortisone
• Other Study ID Numbers: MED(3/12/2023)/(121)ANE921_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No