Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hydrocortisone, ondansetron, Placebo.
- Who it may be relevant to
- Registry conditions: Post Spinal Anaesthesia Hypotension. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intravenous Hydrocortisone Versus Ondansetron in Prevention of Post Spinal Anesthesia Hypotension in Elective Surgeries
Overview
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.
Interventions
- 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. He - 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 r - 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 moto
Primary outcome measures
- hypotension [Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]
Secondary outcome measures (6)
- bradycardia [Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]
- requirement of atropine or ephedrine [Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]
- Doses of administered atropine and ephedrine [Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]
- nausea and vomiting [Time frame: after subarachnoid injection till the end of operation]
- shivering [Time frame: after subarachnoid injection till the end of operation]
- blood pressure and heart rate variations [Time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Port Said Hospital — Port Said
Identifiers
NCT: NCT06930456 · MED(3/12/2023)/(121)ANE921_002