Spinal Induced HypotensionPhase 4NCT04195321
Norepinephrine Versus Phenylephrine for Preventing Spinal Anesthesia Induced Hypotension in Elderly
A Phase 4 study testing Norepinephrine and phenylephrine in people with Spinal Induced Hypotension and Elderly, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Various regimens were used for prevention of hypotension; most of these regimens included the use of vasopressors. Ephedrine is commonly used vasopressor for management and prophylaxis of hypotension; however, ephedrine is usually associated with tachycardia which increases oxygen consumption; thus, it might be… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Induced Hypotension, Elderly
- What is being tested?
- Norepinephrine and phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 26 Mar 2020
- Phase
- Phase 4
- 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 joint surgery under spinal anesthesia
Who cannot join
- Contraindication of spinal anesthesia (patient's refusal, infection at injection site, allergy, increased intracranial tension, coagulopathy, tight valvular lesion),
- history of allergy to any of the study's drugs,
- Patients with cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias),
- hypertensive patients,
- patients on beta blockers,
- patient with hyperthyroidism
- patients on monoamine oxidase inhibitors (MAOI) will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norepinephrine Versus Phenylephrine Infusion for Prophylaxis Against Spinal Induced Hypotension in Elderly Undergoing Hip Arthroplasty Under Spinal Anesthesia: A Randomized Comparative Trial
Various regimens were used for prevention of hypotension; most of these regimens included the use of vasopressors. Ephedrine is commonly used vasopressor for management and prophylaxis of hypotension; however, ephedrine is usually associated with tachycardia which increases oxygen consumption; thus, it might be potentially harmful in this special group of patients. Phenylephrine (PE) is another vasopressor which is characterized by α agonistic activity. PE had been the preferred vasopressor for prophylaxis against post-spinal hypotension especially in obstetric population.
it was reported that PE improved the intraoperative hemodynamic profile in elderly patients undergoing lower extremities orthopedic surgery under spinal anesthesia. PE (a pure α agonist) was reported to decrease cardiac output which limit its use in patients with compromised cardiac contractility; this fact makes the use of PE in elderly patients questionable. Norepinephrine (NE) is characterized by α agonistic and weak β agonistic activity; thus, NE is characterized by less cardiac depression compared to PE. NE was recently introduced for prophylaxis against post-spinal hypotension in obstetric anesthesia. In non-obstetric population, although, NE infusion effectively maintained patients hemodynamics during general anesthesia, its use during spinal anesthesia was not adequately evaluated in elderly population
Read the detailed description
Preoperative fasting instructions are 6 hours for solid food, and clear fluid will be allowed up to 2 hours preoperative. Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 0.02 mg/kg slow IV) will be administrated. Baseline preoperative blood pressure will be recorded in the supine position as average of 3 reading with difference less than 5 mmHg.
Fluid management:
Before initiation of spinal anesthesia for all study patients, Electrical cardiometry device (ICON; Cardiotonic, Osypka; Berlin, Germany) will be applied to the patient through 4 electrodes at the following sites: Below the left ear, Above the midpoint of the left clavicle, Left mid-axillary line at level of the xiphoid process and 5 cm inferior to the third electrode. Stroke volume variability (SVV) will be measured while patient maintaining standard calm breathing at a rate of 6-8 breath/minute before the intrathecal injection. The patient with SVV more than 13% with be considered fluid responder 16 and will receive fluid bolus of 5 ml/kg ringer acetate over 10 minutes. The fluid bolus will be repeated till SVV less than 13%, then spinal anesthesia will be performed. After induction of spinal anesthesia maintenance fluid as 2ml/kg/hour of ringer acetate will be commenced.
Anesthetic management:
Spinal anesthesia will be performed in the sitting position at level of second and third or third and forth lumber interspaces with a 25-gauge spinal needle. After confirming cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the study with a goal of T6-8 dermatomal level block. If spinal anesthesia failed, the patient will be excluded from the study and will be managed according to the attending anesthetist discretion, local expertise and clinical practice.
Vasopressor management:
Vasopressor infusion will be started after obtaining CSF through the same line with IV fluids aided by a three-way stop-cock after induction of spinal anesthesia, patients will receive the vasopressor infusion according to the previous randomization Any episode of spinal induced hypotension (defined as mean arterial pressure < 80% of the baseline reading 30 minutes after spinal block) will be managed by 5 mcg norepinephrine and the infusion rate will be increased by 20%. If the hypotensive episode persisted for 2 minutes, another bolus of norepinephrine will be administered.
If bradycardia (defined as heart rate less than 50 bpm) with hypotension occurred, it will be manged with 0.5 mg of atropine IV. If bradycardia occurred with hypertension (MAP increase 25% over the baseline), the vasopressor infusion will be stopped.
If hypertension occurred (defined as increased mean arterial pressure by > 25% 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. If the patient developed hypotension after stoppage of the infusion, management will depend on the fluid status of the patient. If the cause of hypotension was blood loss, replacement will be done (3:1 of ringer acetate till transfusion threshold met then packed RBC is given with target haemoglobin ≥9gm/dl). If the hypotension was not related to blood loss, vasopressor will be re-initiated at the last dose before stoppage
- Conditions
- Spinal Induced Hypotension, Elderly
- Being tested
- Norepinephrine, phenylephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
infusion will be started after induction of spinal anesthesia
phenylephrineDrug
infusion will be started after induction of spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| norepinephrine group | Active comparator | patients will receive NE infusion at a starting of rate of 1 ml/min of 8 mcg/ml solution (prepared by diluting 4 mg NE in 500 ml normal) Receives: Drug: Norepinephrine |
| phenylephrine | Active comparator | patients will receive PE infusion at a starting rate of 1 ml/min of 100 mcg/ml solution (prepared by diluting 10 mg of PE in 100 ml normal saline) Receives: Drug: phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean heart rate
beat per minute
Measured: for 45 minutes starting 2 minutes after induction of spinal anesthesia
Secondary outcomes (3)
incidence of bradycardia
heart rate less than 60 beat per minute
Measured: for 45 minutes starting 2 minutes after induction of spinal anesthesia
incidence of reactive hypertension
increased mean arterial pressure by > 25% of the baseline reading
Measured: for 45 minutes starting 2 minutes after induction of spinal anesthesia
Incidence of spinal induced hypotension
mean arterial pressure < 80% of the baseline reading 45 minutes after induction of spinal anesthesia and not related to blood loss
Measured: for 45 minutes starting 2 minutes after induction of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2020
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Induced 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195321
- Sponsor's protocol ID
- D-7-2019
- Status last verified
- Aug 2021
- First submitted
- 6 Dec 2019
- Last updated
- 1 Sep 2021
- 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 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Versus Phenylephrine Infusion for Prophylaxis Against Spinal Induced Hypotension in Elderly Undergoing Hip Arthroplasty Under Spinal Anesthesia: A Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT04195321
- Acronym / sponsor ID
- D-7-2019
- Conditions
- Spinal Induced Hypotension, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 11 Dec 2019 (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.
Various regimens were used for prevention of hypotension; most of these regimens included the use of vasopressors. Ephedrine is commonly used vasopressor for management and prophylaxis of hypotension; however, ephedrine is usually associated with tachycardia which increases oxygen consumption; thus, it might be potentially harmful in this special group of patients. Phenylephrine (PE) is another vasopressor which is characterized by α agonistic activity. PE had been the preferred vasopressor for prophylaxis against post-spinal hypotension especially in obstetric population.
it was reported that PE improved the intraoperative hemodynamic profile in elderly patients undergoing lower extremities orthopedic surgery under spinal anesthesia. PE (a pure α agonist) was reported to decrease cardiac output which limit its use in patients with compromised cardiac contractility; this fact makes the use of PE in elderly patients questionable. Norepinephrine (NE) is characterized by α agonistic and weak β agonistic activity; thus, NE is characterized by less cardiac depression compared to PE. NE was recently introduced for prophylaxis against post-spinal hypotension in obstetric anesthesia. In non-obstetric population, although, NE infusion effectively maintained patients hemodynamics during general anesthesia, its use during spinal anesthesia was not adequately evaluated in elderly population
Detailed description
Preoperative fasting instructions are 6 hours for solid food, and clear fluid will be allowed up to 2 hours preoperative. Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 0.02 mg/kg slow IV) will be administrated. Baseline preoperative blood pressure will be recorded in the supine position as average of 3 reading with difference less than 5 mmHg.
Fluid management:
Before initiation of spinal anesthesia for all study patients, Electrical cardiometry device (ICON; Cardiotonic, Osypka; Berlin, Germany) will be applied to the patient through 4 electrodes at the following sites: Below the left ear, Above the midpoint of the left clavicle, Left mid-axillary line at level of the xiphoid process and 5 cm inferior to the third electrode. Stroke volume variability (SVV) will be measured while patient maintaining standard calm breathing at a rate of 6-8 breath/minute before the intrathecal injection. The patient with SVV more than 13% with be considered fluid responder 16 and will receive fluid bolus of 5 ml/kg ringer acetate over 10 minutes. The fluid bolus will be repeated till SVV less than 13%, then spinal anesthesia will be performed. After induction of spinal anesthesia maintenance fluid as 2ml/kg/hour of ringer acetate will be commenced.
Anesthetic management:
Spinal anesthesia will be performed in the sitting position at level of second and third or third and forth lumber interspaces with a 25-gauge spinal needle. After confirming cerebrospinal fluid flow, 10 mg of 0.5% hyperbaric bupivacaine plus 25 mcg fentanyl will be injected. The degree of sensory block (cold test by alcohol gauze) will be assessed in the study with a goal of T6-8 dermatomal level block. If spinal anesthesia failed, the patient will be excluded from the study and will be managed according to the attending anesthetist discretion, local expertise and clinical practice.
Vasopressor management:
Vasopressor infusion will be started after obtaining CSF through the same line with IV fluids aided by a three-way stop-cock after induction of spinal anesthesia, patients will receive the vasopressor infusion according to the previous randomization Any episode of spinal induced hypotension (defined as mean arterial pressure < 80% of the baseline reading 30 minutes after spinal block) will be managed by 5 mcg norepinephrine and the infusion rate will be increased by 20%. If the hypotensive episode persisted for 2 minutes, another bolus of norepinephrine will be administered.
If bradycardia (defined as heart rate less than 50 bpm) with hypotension occurred, it will be manged with 0.5 mg of atropine IV. If bradycardia occurred with hypertension (MAP increase 25% over the baseline), the vasopressor infusion will be stopped.
If hypertension occurred (defined as increased mean arterial pressure by > 25% 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. If the patient developed hypotension after stoppage of the infusion, management will depend on the fluid status of the patient. If the cause of hypotension was blood loss, replacement will be done (3:1 of ringer acetate till transfusion threshold met then packed RBC is given with target haemoglobin ≥9gm/dl). If the hypotension was not related to blood loss, vasopressor will be re-initiated at the last dose before stoppage
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 |
|---|---|---|
| norepinephrine group | Active comparator | Drug: Norepinephrinepatients will receive NE infusion at a starting of rate of 1 ml/min of 8 mcg/ml solution (prepared by diluting 4 mg NE in 500 ml normal) |
| phenylephrine | Active comparator | Drug: phenylephrinepatients will receive PE infusion at a starting rate of 1 ml/min of 100 mcg/ml solution (prepared by diluting 10 mg of PE in 100 ml normal saline) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Elderly patients (>65), ASA I-II-III, scheduled for hip joint surgery under spinal anesthesia
Key exclusion criteria (7 listed)
- Contraindication of spinal anesthesia (patient's refusal, infection at injection site, allergy, increased intracranial tension, coagulopathy, tight valvular lesion),
- history of allergy to any of the study's drugs,
- Patients with cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias),
- hypertensive patients,
- patients on beta blockers,
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 |
|---|---|---|
| Norepinephrineinfusion will be started after induction of spinal anesthesia | Drug | norepinephrine group |
| phenylephrineinfusion will be started after induction of spinal anesthesia | Drug | phenylephrine |
Primary outcome
mean heart rate
Time frame: for 45 minutes starting 2 minutes after induction of spinal anesthesia
beat per minute
3 secondary outcomes
incidence of bradycardia
Time frame: for 45 minutes starting 2 minutes after induction of spinal anesthesia
incidence of reactive hypertension
Time frame: for 45 minutes starting 2 minutes after induction of spinal anesthesia
Incidence of spinal induced hypotension
Time frame: for 45 minutes starting 2 minutes after induction of 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 1 Sep 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine and phenylephrine in people with Spinal Induced Hypotension and Elderly, 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 1 inclusion and 7 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 1 Sep 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 heart rate (time frame: for 45 minutes starting 2 minutes after induction of spinal anesthesia). 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 1 Sep 2021; AzTrials last refreshed its copy on 2 Nov 2026.