Orthopedic Surgery of Lower LimbPhase 2PPSANCT01533662
Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia
A Phase 2 study testing phenylephrine infusion and patients receiving saline infusion in people with Orthopedic Surgery of Lower Limb, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation resulting in hypotension. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Orthopedic Surgery of Lower Limb
- What is being tested?
- phenylephrine infusion and patients receiving saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Sep 2013
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 60 years old
- informed consent
- lower limb orthopaedic surgery
- spinal anesthesia
Who cannot join
- dementia
- anemia less than 10grams per deciliter
- hypertension
- hemostasis disorders
- infection at the puncture
- allergy to local anesthetic,
- patient under anticoagulant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study Evaluating the Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Lower Limb Orthopedic Surgery in the Elderly Patients
Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation resulting in hypotension. A severe and prolonged hypotension can compromise regional perfusion and worse outcome especially in very elderly patients. Moreover the venous vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a cardiac output decrease. Several authors had identified the prevention of hypotension as a key role during spinal anesthesia although none prophylactic treatment has been identified. Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension. Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery. The investigators want to assess for the first time the prophylactic phenylephrine infusion for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under spinal anesthesia single injection.
Read the detailed description
The aim of this study is to assess the prophylactic phenylephrine infusion for preventing hypotension in elderly patients.
This prospective double blinded randomized control trial will include elderly patients over 60 years undergoing orthopedic lower limb surgery under spinal anesthesia single injection (10 mg of Bupivacaine 0,5% with 5 µg of Sufentanyl). We define 4 groups: (1) Patients from 60 to 75 years receiving 100 µg/min of phenylephrine infusion; (2) patients from 60 to 75 years receiving saline infusion; (3) patients over 75 years receiving 100 µg/min of phenylephrine infusion; (4) patients over 75 years receiving saline infusion. Standard monitoring is applied including noninvasive arterial blood pressure, electrocardiography and pulse oximetry. The vasopressor solution and the saline solution will be prepared in identical 50 mL syringes by an investigator not involved in patient care. The investigator administering the solution and the patient are blinded to the content of the syringe. The velocity of infusion will be the same between groups (1ml/min) and the infusion will start once the spinal anesthesia realized. Arterial blood pressure measurements are realized each 1 minute for the first 20 minutes and then each 5 minutes until the end of surgery. After each measurement of MAP, the infusion is stopped if the MAP is more than baseline, and it is continued or restarted if the MAP is less than or equal to baseline. Anyway the infusion is stopped at the end of motor block. Hypotension is defined as a 20% decrease of mean arterial pressure (MAP). Severe hypotension is defined as a 30% decrease of MAP. Hypertension is defined as MAP > 120% of baseline. Each time there is a MAP measurement showing hypotension while patients are under infusion, a 1 mL IV bolus of phenylephrine 100µg/ml is injected by the anesthesiologist involved in patient care. The total volume of study solution given by infusion and the total volume of phenylephrine given by bolus are recorded.
We want to demonstrate fewer episodes of hypotension and fewer post operatory cardiovascular and neurologic events in the groups receiving prophylactic phenylephrine infusion.
- Conditions
- Orthopedic Surgery of Lower Limb
- Being tested
- phenylephrine infusion, patients receiving saline infusion
- Keywords
- phenylephrine, hypotension, spinal anesthesia, lower limb orthopedic surgery
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenylephrine infusionDrug
patients from 60 to 75 years receiving 100micrograms of phenylephrine infusion
patients receiving saline infusionDrug
patients more than 60 years receiving 100micrograms of saline infusion
| Study group | Role | What they receive |
|---|---|---|
| phenylephrine | Experimental | patients more than 60 years receiving 100micrograms of phenylephrine infusion (2 groups 60-75 years and more than 75 years) Receives: Drug: phenylephrine infusion |
| placebo | Placebo comparator | patients more than 60 years receiving saline infusion (2 groups 60-75 years and more than 75) Receives: Drug: patients receiving saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hypotension episodes
at the end of solution infusion
Measured: 48h after infusion
Secondary outcomes (3)
number of episodes of severe hypotension
at the end of solution infusion
Measured: 48h after infusion
cardiovascular events
at the end of the solution infusion
Measured: 48h after infusion
neurologic events
at the end of solution infusion
Measured: 48h after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionMay 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Surgery of Lower LimbStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Minville, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533662
- Sponsor's protocol ID
- 0900103
- Acronym
- PPSA
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2011
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Evaluating the Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Lower Limb Orthopedic Surgery in the Elderly Patients
- ClinicalTrials.gov ID
- NCT01533662
- Acronym / sponsor ID
- PPSA / 0900103
- Conditions
- Orthopedic Surgery of Lower Limb
- Keywords
- phenylephrine, hypotension, spinal anesthesia, lower limb orthopedic surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Feb 2012 (estimated)
- 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.
Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation resulting in hypotension. A severe and prolonged hypotension can compromise regional perfusion and worse outcome especially in very elderly patients. Moreover the venous vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a cardiac output decrease. Several authors had identified the prevention of hypotension as a key role during spinal anesthesia although none prophylactic treatment has been identified. Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension. Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery. The investigators want to assess for the first time the prophylactic phenylephrine infusion for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under spinal anesthesia single injection.
Detailed description
The aim of this study is to assess the prophylactic phenylephrine infusion for preventing hypotension in elderly patients.
This prospective double blinded randomized control trial will include elderly patients over 60 years undergoing orthopedic lower limb surgery under spinal anesthesia single injection (10 mg of Bupivacaine 0,5% with 5 µg of Sufentanyl). We define 4 groups: (1) Patients from 60 to 75 years receiving 100 µg/min of phenylephrine infusion; (2) patients from 60 to 75 years receiving saline infusion; (3) patients over 75 years receiving 100 µg/min of phenylephrine infusion; (4) patients over 75 years receiving saline infusion. Standard monitoring is applied including noninvasive arterial blood pressure, electrocardiography and pulse oximetry. The vasopressor solution and the saline solution will be prepared in identical 50 mL syringes by an investigator not involved in patient care. The investigator administering the solution and the patient are blinded to the content of the syringe. The velocity of infusion will be the same between groups (1ml/min) and the infusion will start once the spinal anesthesia realized. Arterial blood pressure measurements are realized each 1 minute for the first 20 minutes and then each 5 minutes until the end of surgery. After each measurement of MAP, the infusion is stopped if the MAP is more than baseline, and it is continued or restarted if the MAP is less than or equal to baseline. Anyway the infusion is stopped at the end of motor block. Hypotension is defined as a 20% decrease of mean arterial pressure (MAP). Severe hypotension is defined as a 30% decrease of MAP. Hypertension is defined as MAP > 120% of baseline. Each time there is a MAP measurement showing hypotension while patients are under infusion, a 1 mL IV bolus of phenylephrine 100µg/ml is injected by the anesthesiologist involved in patient care. The total volume of study solution given by infusion and the total volume of phenylephrine given by bolus are recorded.
We want to demonstrate fewer episodes of hypotension and fewer post operatory cardiovascular and neurologic events in the groups receiving prophylactic phenylephrine infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phenylephrine | Experimental | Drug: phenylephrine infusionpatients more than 60 years receiving 100micrograms of phenylephrine infusion (2 groups 60-75 years and more than 75 years) |
| placebo | Placebo comparator | Drug: patients receiving saline infusionpatients more than 60 years receiving saline infusion (2 groups 60-75 years and more than 75) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 60 years old
- informed consent
- lower limb orthopaedic surgery
- spinal anesthesia
Key exclusion criteria (7 listed)
- dementia
- anemia less than 10grams per deciliter
- hypertension
- hemostasis disorders
- infection at the puncture
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 |
|---|---|---|
| phenylephrine infusionpatients from 60 to 75 years receiving 100micrograms of phenylephrine infusion | Drug | phenylephrine |
| patients receiving saline infusionpatients more than 60 years receiving 100micrograms of saline infusion | Drug | placebo |
Primary outcome
number of hypotension episodes
Time frame: 48h after infusion
at the end of solution infusion
3 secondary outcomes
number of episodes of severe hypotension
Time frame: 48h after infusion
cardiovascular events
Time frame: 48h after infusion
neurologic events
Time frame: 48h after infusion
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 23 Jun 2014.
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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.
Vincent Minville, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing phenylephrine infusion and patients receiving saline infusion in people with Orthopedic Surgery of Lower Limb, run by University Hospital, Toulouse at 1 site in France.
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 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 23 Jun 2014. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
number of hypotension episodes (time frame: 48h after infusion). 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 23 Jun 2014.