Post Spinal Anaesthesia HypotensionNCT06930456
Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension
A study testing hydrocortisone and ondansetron in people with Post Spinal Anaesthesia Hypotension, run by Nada kamel Elgamal at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Post Spinal Anaesthesia Hypotension
- What is being tested?
- hydrocortisone and ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Known intolerance to the study drugs.
- patients already receiving any of the study drugs.
- diabetic patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intravenous Hydrocortisone Versus Ondansetron in Prevention of Post Spinal Anesthesia Hypotension in Elective Surgeries
The purpose of this study is to assess and contrast the effectiveness of intravenous ondansetron and intravenous hydrocortisone in avoiding spinal anesthesia-induced hypotension.
Read the 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:
- Hydrocortisone 100 mg (H group)
- Ondansetron 8 mg (O group)
- 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
- Being tested
- hydrocortisone, ondansetron, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
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.
ondansetronDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone (H) group | Active comparator | As in intervention description Receives: Drug: hydrocortisone |
| Ondansetron (O) group | Active comparator | As in intervention description Receives: Drug: ondansetron |
| control (C) group | Placebo comparator | As in intervention description Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
Secondary outcomes (6)
bradycardia
The percentage of patients experiencing bradycardia (HR less than 50 beat/min) at any point in the first thirty-minute period following spinal anesthesia.
Measured: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
requirement of atropine or ephedrine
The proportion of those who require atropine or ephedrine for management of bradycardia or hypotension
Measured: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
Doses of administered atropine and ephedrine
Doses of administered atropine and ephedrine
Measured: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
nausea and vomiting
Incidence of post spinal nausea and vomiting till the end of operation
Measured: after subarachnoid injection till the end of operation
shivering
Incidence of post spinal shivering till the end of operation
Measured: after subarachnoid injection till the end of operation
blood pressure and heart rate variations
Variations in blood pressure and Heart Rate (HR).
Measured: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anaesthesia HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nada kamel Elgamal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nada kamel Elgamal, Port Said University hospital
- Investigators
- Magdy Ali Omera, prof. of Anesthesia and ICU, Study chair, Port Said University, Faculty of Medicine, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930456
- Sponsor's protocol ID
- MED(3/12/2023)/(121)ANE921_002
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Hydrocortisone Versus Ondansetron in Prevention of Post Spinal Anesthesia Hypotension in Elective Surgeries
- ClinicalTrials.gov ID
- NCT06930456
- Acronym / sponsor ID
- MED(3/12/2023)/(121)ANE921_002
- Conditions
- Post Spinal Anaesthesia Hypotension
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nada kamel ElgamalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Hydrocortisone 100 mg (H group)
- Ondansetron 8 mg (O group)
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone (H) group | Active comparator | Drug: hydrocortisoneAs in intervention description |
| Ondansetron (O) group | Active comparator | Drug: ondansetronAs in intervention description |
| control (C) group | Placebo comparator | Drug: PlaceboAs in intervention description |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocortisoneA 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. | Drug | Hydrocortisone (H) group |
| ondansetronA 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. | Drug | Ondansetron (O) group |
| PlaceboA 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. | Drug | control (C) group |
Primary outcome
hypotension
Time frame: 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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magdy Ali Omera, prof. of Anesthesia and ICU study chair
Port Said University, Faculty of Medicine, Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrocortisone and ondansetron in people with Post Spinal Anaesthesia Hypotension, run by Nada kamel Elgamal at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypotension (time frame: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.