Clinical trial NCT06930456: Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension
Official title: Intravenous Hydrocortisone Versus Ondansetron in Prevention of Post Spinal Anesthesia Hypotension in Elective Surgeries
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Post Spinal Anaesthesia Hypotension
Lead sponsor: Port Said University hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: hypotension
timeFrame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
Secondary outcomes:
measure: bradycardia
timeFrame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
measure: requirement of atropine or ephedrine
timeFrame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
measure: Doses of administered atropine and ephedrine
timeFrame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
measure: nausea and vomiting
timeFrame: after subarachnoid injection till the end of operation
measure: shivering
timeFrame: after subarachnoid injection till the end of operation
measure: blood pressure and heart rate variations
timeFrame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
Other outcomes:
Locations:
city: Port Said
country: Egypt
facility: Port Said Hospital
Study officials:
affiliation: Port Said University, Faculty of Medicine, Department of Anesthesia
name: Magdy Ali Omera, prof. of Anesthesia and ICU
role: STUDY_CHAIR
References: