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

NCT06930456 | Enrolling By Invitation

• 1 other identifier: MED(3/12/2023)/(121)ANE921_002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Spinal Anaesthesia Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• bradycardia

  5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

• requirement of atropine or ephedrine

  5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

• Doses of administered atropine and ephedrine

  5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration

• nausea and vomiting

  after subarachnoid injection till the end of operation

• shivering

  after subarachnoid injection till the end of operation

Study Arms (3)

Hydrocortisone (H) group

ACTIVE COMPARATOR

As in intervention description

Drug: hydrocortisone

Ondansetron (O) group

ACTIVE COMPARATOR

As in intervention description

Drug: ondansetron

control (C) group

PLACEBO COMPARATOR

As in intervention description

Drug: Placebo

Interventions

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.

Hydrocortisone (H) group

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.

Ondansetron (O) group

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.

control (C) group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nada kamel Elgamal: lead

Study Sites (1)

Port Said Hospital

Port Said, Port Said Governorate, Egypt

Location

MeSH Terms

Interventions

Hydrocortisone; Ondansetron

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Magdy Ali Omera, prof. of Anesthesia and ICU

  Port Said University, Faculty of Medicine, Department of Anesthesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia and ICU

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

EG (1)