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

Not Applicable

• Conditions: Post Spinal Anaesthesia Hypotension
• Interventions: Drug: hydrocortisone; Drug: ondansetron; Drug: Placebo

• Registration Number: NCT06930456
• Lead Sponsor: Nada kamel Elgamal

Brief 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.

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 Timeline

• Study Start: 2024-03-01
• Primary Completion: 2025-03-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocortisone (H) group	hydrocortisone	As in intervention description
Ondansetron (O) group	ondansetron	As in intervention description
control (C) group	Placebo	As in intervention description

Primary Outcome Measures

Name	Time	Method
hypotension	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 Outcome Measures

Name	Time	Method
bradycardia	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.
requirement of atropine or ephedrine	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
Doses of administered atropine and ephedrine	5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration	Doses of administered atropine and ephedrine
nausea and vomiting	after subarachnoid injection till the end of operation	Incidence of post spinal nausea and vomiting till the end of operation
shivering	after subarachnoid injection till the end of operation	Incidence of post spinal shivering till the end of operation
blood pressure and heart rate variations	5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration	Variations in blood pressure and Heart Rate (HR).

Trial Locations

Locations (1)

Port Said Hospital; 🇪🇬 Port Said, Egypt