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

NCT ID: NCT06930456

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-05-01

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.

Conditions

Post Spinal Anaesthesia Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hydrocortisone (H) group

As in intervention description

Group Type: ACTIVE_COMPARATOR

hydrocortisone

Intervention Type: 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.

Ondansetron (O) group

As in intervention description

Group Type: ACTIVE_COMPARATOR

ondansetron

Intervention Type: 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.

control (C) group

As in intervention description

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nada kamel Elgamal

OTHER

Sponsor Role: lead

Responsible Party

Nada kamel Elgamal

Assistant Lecturer of Anesthesia and ICU

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Magdy Ali Omera, prof. of Anesthesia and ICU

Role: STUDY_CHAIR

Port Said University, Faculty of Medicine, Department of Anesthesia

Locations

Port Said Hospital

Port Said, Port Said Governorate, Egypt

Countries

Egypt

Other Identifiers

MED(3/12/2023)/(121)ANE921_002

Identifier Type: -

Identifier Source: org_study_id