Spinal AneshtesiaNCT07077265
Comparing Two Different Norepinephrine Infusion Rates for Prophylaxis Against Spinal-induced Hypotension in Elderly
A study testing Norepinephrine (0.1 μg/kg/min) and Norepinephrine (0.07 μg/kg/min) in people with Spinal Aneshtesia and Hypotension After Spinal Anesthesia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The current study aims to determine whether norepinephrine infusion rate (0.07 mcg/kg/min) is non-inferior to the higher dose (0.1 mcg/kg/min) in maintaining intraoperative blood pressure maintaining blood pressure of elderly patients during hip surgery Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Aneshtesia, Hypotension After Spinal Anesthesia, Elderly (People Aged 65 or More)
- What is being tested?
- Norepinephrine (0.1 μg/kg/min) and Norepinephrine (0.07 μg/kg/min)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients (>65)
- ASA I-II-III
- scheduled for hip surgery under spinal anesthesia
Who cannot join
- Contraindication of spinal anesthesia
- history of allergy to any of the study's drugs,
- Patients with cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias)
- patients with uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Two Different Norepinephrine Infusion Rates for Prophylaxis Against Spinal-induced Hypotension in Elderly Patients Undergoing Hip Surgery: A Randomized Controlled Non-inferiority Trial
The current study aims to determine whether norepinephrine infusion rate (0.07 mcg/kg/min) is non-inferior to the higher dose (0.1 mcg/kg/min) in maintaining intraoperative blood pressure maintaining blood pressure of elderly patients during hip surgery
Read the detailed description
Baseline preoperative blood pressure will be recorded in the supine position as average of 3 reading with difference less than 5 mmHg in the mean arterial pressure.
Inferior vena cava collapsibility will be used to assess the patient's intravascular volume status.
After induction of spinal anesthesia, patients will receive the vasopressor infusion according to the previous randomization All drug preparations will be done by a research assistant who will be responsible for opening the envelope and group assignment with no further involvement in the study.
Any episode of hypotension (defined as mean arterial pressure (MAP) < 70% of the baseline or MAP<65mmHg) will be managed by 5 mcg norepinephrine.
If bradycardia (defined as heart rate less than 50 bpm) with hypotension occurred, it will be manged with 9 mg ephedrine. If bradycardia occurred with hypertension (MAP increase 20% over the baseline) and persisted for more than one reading, the vasopressor infusion will be stopped.
If hypertension occurred (defined as increased mean arterial pressure by > 20% of the baseline reading), vasopressor infusion will be decreased by 50%. If hypertension persisted 2 minutes after reduction of the infusion, the vasopressor infusion will be stopped. The vasopressor will be returned to 50% of the starting dose if there was further decline in blood pressure.
The infusion will continue for 45 minutes after spinal anesthesia.
- Being tested
- Norepinephrine (0.1 μg/kg/min), Norepinephrine (0.07 μg/kg/min)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norepinephrine (0.1 μg/kg/min)Drug
The patients will receive norepinephrine infusion at a rate 1 mL/kg/hour of 6 mcg/mL solution.
Norepinephrine (0.07 μg/kg/min)Drug
The patients will receive NE infusion at a rate 1 mL/kg/hour of 4.2 mcg/mL solution.
| Study group | Role | What they receive |
|---|---|---|
| NE 0.1 mcg | Active comparator | norepinephrine infusion rate of 0.1 mcg/kg/min Receives: Drug: Norepinephrine (0.1 μg/kg/min) |
| NE 0.07 mcg | Active comparator | norepinephrine infusion rate of 0.07 mcg/kg/min Receives: Drug: Norepinephrine (0.07 μg/kg/min) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial pressure
average mean arterial pressure
Measured: 0 min after spinal anesthesia till 46 min after spinal anesthesia
Secondary outcomes (3)
incidence of hypotension
defined as mean MAP < 70% of the baseline or MAP<65mmHg
Measured: 0 min after spinal anesthesia till 46 min after spinal anesthesia
incidence of reactive hypertension
defined as mean MAP > 120% of the baseline
Measured: 0 min after spinal anesthesia till 46 min after spinal anesthesia
incidence of bradycardia
defined as heart rate <50 bpm
Measured: 0 min after spinal anesthesia till 46 min after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal AneshtesiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
- Investigators
- Maha Mostafa, MD, Principal investigator, Cairo University Kasr Alainy Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077265
- Sponsor's protocol ID
- MD-25-2024
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Wahib M, Mostafa M, Hasanin A, Alashmawy EA, Mustafa M, Taha MY, Amin S, Zakaria D, Fawzy D. Norepinephrine infusion for prophylaxis against spinal-induced hypotension in elderly patients undergoing hip surgery: a randomized controlled comparison of two doses. BMC Anesthesiol. 2026 Aug 20;26(1):542. doi: 10.1186/s12871-026-04174-3.
PubMed 42675458
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Different Norepinephrine Infusion Rates for Prophylaxis Against Spinal-induced Hypotension in Elderly Patients Undergoing Hip Surgery: A Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07077265
- Acronym / sponsor ID
- MD-25-2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 22 Jul 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 current study aims to determine whether norepinephrine infusion rate (0.07 mcg/kg/min) is non-inferior to the higher dose (0.1 mcg/kg/min) in maintaining intraoperative blood pressure maintaining blood pressure of elderly patients during hip surgery
Detailed description
Baseline preoperative blood pressure will be recorded in the supine position as average of 3 reading with difference less than 5 mmHg in the mean arterial pressure.
Inferior vena cava collapsibility will be used to assess the patient's intravascular volume status.
After induction of spinal anesthesia, patients will receive the vasopressor infusion according to the previous randomization All drug preparations will be done by a research assistant who will be responsible for opening the envelope and group assignment with no further involvement in the study.
Any episode of hypotension (defined as mean arterial pressure (MAP) < 70% of the baseline or MAP<65mmHg) will be managed by 5 mcg norepinephrine.
If bradycardia (defined as heart rate less than 50 bpm) with hypotension occurred, it will be manged with 9 mg ephedrine. If bradycardia occurred with hypertension (MAP increase 20% over the baseline) and persisted for more than one reading, the vasopressor infusion will be stopped.
If hypertension occurred (defined as increased mean arterial pressure by > 20% of the baseline reading), vasopressor infusion will be decreased by 50%. If hypertension persisted 2 minutes after reduction of the infusion, the vasopressor infusion will be stopped. The vasopressor will be returned to 50% of the starting dose if there was further decline in blood pressure.
The infusion will continue for 45 minutes after spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NE 0.1 mcg | Active comparator | Drug: Norepinephrine (0.1 μg/kg/min)norepinephrine infusion rate of 0.1 mcg/kg/min |
| NE 0.07 mcg | Active comparator | Drug: Norepinephrine (0.07 μg/kg/min)norepinephrine infusion rate of 0.07 mcg/kg/min |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderly patients (>65)
- ASA I-II-III
- scheduled for hip surgery under spinal anesthesia
Key exclusion criteria (4 listed)
- Contraindication of spinal anesthesia
- history of allergy to any of the study's drugs,
- Patients with cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias)
- patients with uncontrolled hypertension
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 |
|---|---|---|
| Norepinephrine (0.1 μg/kg/min)The patients will receive norepinephrine infusion at a rate 1 mL/kg/hour of 6 mcg/mL solution. | Drug | NE 0.1 mcg |
| Norepinephrine (0.07 μg/kg/min)The patients will receive NE infusion at a rate 1 mL/kg/hour of 4.2 mcg/mL solution. | Drug | NE 0.07 mcg |
Primary outcome
mean arterial pressure
Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia
average mean arterial pressure
3 secondary outcomes
incidence of hypotension
Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia
incidence of reactive hypertension
Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia
incidence of bradycardia
Time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 42675458Wahib M, Mostafa M, Hasanin A, Alashmawy EA, Mustafa M, Taha MY, Amin S, Zakaria D, Fawzy D. Norepinephrine infusion for prophylaxis against spinal-induced hypotension in elderly patients undergoing hip surgery: a randomized controlled comparison of two doses. BMC Anesthesiol. 2026 Aug 20;26(1):542. doi: 10.1186/s12871-026-04174-3.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Related trials for Spinal Aneshtesia
RecruitingObservational study
Spinal Anaesthesia Success in Patients With Previous Lumbar Spine Surgery
Spinal Surgery, Spinal Aneshtesia
Enrolling by invitation
Dural Sac Area-Guided Spinal Anesthesia Dosing for TURP
Intraoperative Hypotension, Spinal Aneshtesia
RecruitingPhase 4
Routine Antiemetic Prophylaxis for Nonfasted Parturients Undergoing Cesarean Sections Under Spinal Anesthesia
Intraoperative Nausea-retching-vomiting Episodes, Spinal Aneshtesia
Active, not recruiting
Effect of IV Dexamethasone on Post-op Urinary Retention After Spinal Anesthesia
Post Operative Urinary Retention, Spinal Aneshtesia
Not yet recruiting
Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients
Hypotension Drug-Induced, Spinal Aneshtesia
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. This study is not recruiting at the moment.
Maha Mostafa, MD principal investigator
Cairo University Kasr Alainy Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine (0.1 μg/kg/min) and Norepinephrine (0.07 μg/kg/min) in people with Spinal Aneshtesia and Hypotension After Spinal Anesthesia, run by Kasr El Aini Hospital 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Mar 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mean arterial pressure (time frame: 0 min after spinal anesthesia till 46 min after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07077265, which also lists 1 linked publication.
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 24 Mar 2026.