Hip FracturesNCT05799300
Haemodynamic Effects of Low-dose Spinal Anaesthesia for Hip Fracture Surgery.
An observational study of Hip Fractures, run by Royal Sussex County Hospital at 1 site in United Kingdom.
Trial summary
Approximately 65, 000 hip fractures occur in the United Kingdom (UK) each year, and more than 99% are repaired by surgery. Roughly half of patients receive spinal anaesthesia, where a small amount (usually less than half a teaspoonful) of local anaesthetic is injected into the lower back, around the nerves that go to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Intrathecal anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2017to 24 May 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People undergoing surgical hip fracture repair (hemiarthoplasty, dynamic hip screw, cortical screws, proximal femoral nail) administered spinal anaesthesia for whom contemporaneous vital signs (including blood pressure, heart rate, oxygen saturation, breathing rate) have been stored in an anonymised, double password-protected database held on secure computers at Princess Royal Hospital, Hayward's Heath (E. Sussex).
Who may be able to join
- Adults (over 18 years) who have sustained a unilateral hip fracture and received surgery (hemiarthroplasty, dynamic hip screw, cortical screws, proximal femoral nail) under low dose spinal anaesthesia (1.3 mls 0.5% hyperbaric bupivacaine) after fascia iliaca block + sedation, administered by the Chief Investigator (CI) between 3rd March, 2017 and 1st January, 2020 at the Princess Royal Hospital, Hayward's Heath (E Sussex).
- For whom crude vital signs data have been stored in pseudo-anonymised electronic form on secure hospital computers, for medico-legal reference
Who cannot join
- People with hip fracture receiving conservative management during the study period;
- People with hip fracture requiring total hip arthroplasty (for whom larger volumes of spinal anaesthesia are used);
- People with hip fracture administered spinal anaesthesia other than 1.3 mls 0.5% hyperbaric bupivacaine;
- People meeting inclusion criteria for whom vital signs could not be stored electronically due to equipment failure.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Sussex County Hospital
Brighton, E Sussex, BN2 5BE
About this study
Official title: A Retrospective, Observational, Single-centre, Cohort Database Analysis of the Haemodynamic Effects of Low-dose Spinal Anaesthesia for Hip Fracture Surgery.
Approximately 65, 000 hip fractures occur in the United Kingdom (UK) each year, and more than 99% are repaired by surgery. Roughly half of patients receive spinal anaesthesia, where a small amount (usually less than half a teaspoonful) of local anaesthetic is injected into the lower back, around the nerves that go to and from the hip.
Low blood pressure is very common during surgery (at least > 30%, depending on definition), and appears to be linked to a greater chance of death within a month after surgery.
Read more
There are 2 main ways of managing low blood pressure during surgery: treatment and prevention. Treatments (fluids, drugs) have side effects in the older, frailer population with hip fracture. Prevention involves giving anaesthesia at lower doses. National guidelines recommend that lower doses are given, but this recommendation is based on historical research selectively involving younger, fitter people having hip fracture surgery. Importantly, these studies did not record blood pressure either accurately or often enough.
The Anaesthesia Sprint Audit of Practice (ASAP) 2 study suggested that a safe level of low blood pressure occurs when only 1.5 mls of spinal anaesthesia is given, and the investigator has been using this amount in Brighton since 2011. Recently, the investigator has reported a way of transferring vital signs data from anaesthetic monitors to storage computers for medicolegal purposes (e.g. in Coroner's investigations: approximately 4000 people in the UK die annually within a month of hip fracture surgery).
However, analyzing such observational data should also allow the investigator to describe accurately how blood pressure changes around the time of surgery, and in patient groups that are normally excluded from prospective research (e.g. the very old, the very frail, people with dementia). By comparing this data to published national data from the ASAP 1 study, the investigator hopes to determine whether lower doses of spinal anaesthesia are linked with a lower rate of low blood pressure during surgery, potentially improving people's survival and recovery after hip fracture.
Read the detailed description
Approximately 65, 000 hip fractures occur in the UK each year, and more than 99% are repaired by surgery. Roughly half of patients receive spinal anaesthesia, where a small amount (usually ~ 2.5mls) of local anaesthetic is injected into the lower back, around the nerves that go to and from the hip.
The investigator has found that low blood pressure (hypotension) is very common during surgery (occurring in at least > 30%, depending on the definition of hypotension), and appears to be significantly linked to a greater chance of death within a month after surgery (~3% rise in mortality/5 mmHg fall in SBP).
There are 2 main ways of managing low blood pressure during surgery: treatment and prevention. Treatments (fluids, drugs) have side effects in the older, frailer population with hip fracture, including fluid overload with heart failure, and cardiac/kidney/gut ischaemia.
Prevention involves giving anaesthesia at lower doses. UK national guidelines recommend that lower doses are given (< 2mls 0.5% hyperbaric bupivacaine), but this recommendation is based on historical research selectively involving younger, fitter people having hip fracture surgery. Importantly, these studies did not record blood pressure either accurately (i.e. invasively) or often enough (i.e. > every 5 minutes).
The ASAP 2 study suggested that a safe level of low blood pressure occurs when only 1.44 mls 0.5% hyperbaric/normobaric spinal anaesthesia is administered, and the investigator has been using this amount (1.5mls) in Brighton since 2011.
Recently, it has become possible to transfer vital signs data from anaesthetic monitors to storage computers for medicolegal purposes (eg in Coroner's investigations - approximately 4000 people in the UK die annually within a month of hip fracture surgery).
However, analyzing such observational medicolegal data should also allow accurate description of how blood pressure changes around the time of surgery, and in patient groups that are normally excluded from prospective research (eg the very old, the very frail, people with dementia). By comparing this data to published national data from the ASAP 1 study, it should be possible to determine whether lower doses of spinal anaesthesia are linked with a lower rate of low blood pressure during surgery. By merging individuals' data with that held on the Brighton Hip Fracture Database, it should be possible to determine whether prevalence (and/or depth+duration of hypotension) are correlated with outcomes (survival, length of inpatient stay) after hip fracture repair.
- Conditions
- Hip Fractures
- Being tested
- Intrathecal anaesthesia
- Keywords
- Anaesthesia, spinal, Anaesthesia, cardiovascular effects, Surgery, hip fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal anaesthesiaProcedure or surgery
Low dose 0.5% hyperbaric bupivacaine (1.3mls, 0.65mg) intrathecal anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Hip fracture cohort | Gender, Age, Racial and Ethnic Origin of Subjects Male and female adults over the age of 18 years; all origins, all races will be included.
Inclusion/exclusion criteria as below Receives: Procedure: Intrathecal anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort mean (SD) mean non-invasive blood pressure (MAP)
Taken at 2 minute intervals peri-operatively for each patient
Measured: Occurring during the 2 hour duration (approximately) of anaesthesia and surgery for each patient
Secondary outcomes (5)
The cohort prevalence of hypotension
Cohort prevalence of hypotension, variably defined as:
- Fall in systolic blood pressure (SBP) from baseline > 20%;
- Fall in systolic blood pressure (SBP) from baseline > 30%;
- Fall in mean arterial pressure (MAP) from baseline > 20%;
- Fall in mean arterial pressure (MAP) from baseline > 30%;
- Lowest SBP < 90 millimetres of mercury (mmHg);
- Lowest SBP < 100 mmHg
- Lowest MAP < 70 mmHg;
- Lowest MAP < 55 mmHg.
Measured: During anaesthesia and surgery
Mean depth x duration area under curve product for cohort hypotension after low dose spinal anaesthesia for hip fracture surgery
Mean depth x duration area under curve product for cohort hypotension after low dose spinal anaesthesia for hip fracture surgery
Measured: During anaesthesia and surgery
Quantification of cohort systolic and mean arterial blood pressure changes before spinal administration
Describing any effects of propofol sedation and local anaesthetic nerve block
Measured: During anaesthesia and surgery
Effective cohort duration of spinal anaesthesia
Including number of augmentatory anaesthetic interventions required in mean (SD) time from spinal administration to surgical skin closure
Measured: During anaesthesia and surgery
Correlations between individual (a) hypotension (b) hypotension depth/duration product and outcomes (death at 30 days, length of stay in hospital)
Correlations between individual (a) hypotension (b) hypotension depth/duration product and outcomes (death at 30 days, length of stay in hospital)
Measured: During anaesthesia and surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start3 Mar 2017
- Primary completion24 May 2023 (estimated)
- Study completion24 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Sussex County Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart White, Royal Sussex County Hospital
- Investigators
- Stu White, FRCA BSc MA, Principal investigator, Consultant Anaesthetist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799300
- Sponsor's protocol ID
- RoyalSussex
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On application to PI
Publications
National Hip Fracture Database. 2019 Report. https://www.nhfd.co.uk/20/hipfractureR.nsf/docs/2019Report
National Hip Fracture Database. Anaesthesia Sprint Audit of Practice (ASAP). 2014. https://www.nhfd.co.uk/20/hipfractureR.nsf/vwContent/asapReport/$file/onlineASAP.pdf
White SM, Moppett IK, Griffiths R, Johansen A, Wakeman R, Boulton C, Plant F, Williams A, Pappenheim K, Majeed A, Currie CT, Grocott MP. Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice (ASAP-2). Anaesthesia. 2016 May;71(5):506-14. doi: 10.1111/anae.13415. Epub 2016 Mar 4.
PubMed 26940645Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.
PubMed 33289066Ben-David B, Frankel R, Arzumonov T, Marchevsky Y, Volpin G. Minidose bupivacaine-fentanyl spinal anesthesia for surgical repair of hip fracture in the aged. Anesthesiology. 2000 Jan;92(1):6-10. doi: 10.1097/00000542-200001000-00007.
PubMed 10638892Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
PubMed 16632842White SM, Pateman J. A method of recording electronic anaesthetic monitor data for research. Anaesthesia. 2017 Feb;72(2):267-269. doi: 10.1111/anae.13794. No abstract available.
PubMed 28093744White SM, Rashid N, Chakladar A. An analysis of renal dysfunction in 1511 patients with fractured neck of femur: the implications for peri-operative analgesia. Anaesthesia. 2009 Oct;64(10):1061-5. doi: 10.1111/j.1365-2044.2009.06012.x.
PubMed 19735395White SM. A retrospective, observational, single-centre, cohort database analysis of the haemodynamic effects of low-dose spinal anaesthesia for hip fracture surgery. BJA Open. 2024 Feb 17;9:100261. doi: 10.1016/j.bjao.2024.100261. eCollection 2024 Mar.
PubMed 38390395
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, Single-centre, Cohort Database Analysis of the Haemodynamic Effects of Low-dose Spinal Anaesthesia for Hip Fracture Surgery.
- ClinicalTrials.gov ID
- NCT05799300
- Acronym / sponsor ID
- RoyalSussex
- Conditions
- Hip Fractures
- Keywords
- Anaesthesia, spinal, Anaesthesia, cardiovascular effects, Surgery, hip fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Royal Sussex County HospitalUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 24 May 2023 (estimated)
- Study completion
- 24 May 2023 (estimated)
- First posted
- 5 Apr 2023 (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.
Approximately 65, 000 hip fractures occur in the United Kingdom (UK) each year, and more than 99% are repaired by surgery. Roughly half of patients receive spinal anaesthesia, where a small amount (usually less than half a teaspoonful) of local anaesthetic is injected into the lower back, around the nerves that go to and from the hip.
Low blood pressure is very common during surgery (at least > 30%, depending on definition), and appears to be linked to a greater chance of death within a month after surgery.
There are 2 main ways of managing low blood pressure during surgery: treatment and prevention. Treatments (fluids, drugs) have side effects in the older, frailer population with hip fracture. Prevention involves giving anaesthesia at lower doses. National guidelines recommend that lower doses are given, but this recommendation is based on historical research selectively involving younger, fitter people having hip fracture surgery. Importantly, these studies did not record blood pressure either accurately or often enough.
The Anaesthesia Sprint Audit of Practice (ASAP) 2 study suggested that a safe level of low blood pressure occurs when only 1.5 mls of spinal anaesthesia is given, and the investigator has been using this amount in Brighton since 2011. Recently, the investigator has reported a way of transferring vital signs data from anaesthetic monitors to storage computers for medicolegal purposes (e.g. in Coroner's investigations: approximately 4000 people in the UK die annually within a month of hip fracture surgery).
However, analyzing such observational data should also allow the investigator to describe accurately how blood pressure changes around the time of surgery, and in patient groups that are normally excluded from prospective research (e.g. the very old, the very frail, people with dementia). By comparing this data to published national data from the ASAP 1 study, the investigator hopes to determine whether lower doses of spinal anaesthesia are linked with a lower rate of low blood pressure during surgery, potentially improving people's survival and recovery after hip fracture.
Detailed description
Approximately 65, 000 hip fractures occur in the UK each year, and more than 99% are repaired by surgery. Roughly half of patients receive spinal anaesthesia, where a small amount (usually ~ 2.5mls) of local anaesthetic is injected into the lower back, around the nerves that go to and from the hip.
The investigator has found that low blood pressure (hypotension) is very common during surgery (occurring in at least > 30%, depending on the definition of hypotension), and appears to be significantly linked to a greater chance of death within a month after surgery (~3% rise in mortality/5 mmHg fall in SBP).
There are 2 main ways of managing low blood pressure during surgery: treatment and prevention. Treatments (fluids, drugs) have side effects in the older, frailer population with hip fracture, including fluid overload with heart failure, and cardiac/kidney/gut ischaemia.
Prevention involves giving anaesthesia at lower doses. UK national guidelines recommend that lower doses are given (< 2mls 0.5% hyperbaric bupivacaine), but this recommendation is based on historical research selectively involving younger, fitter people having hip fracture surgery. Importantly, these studies did not record blood pressure either accurately (i.e. invasively) or often enough (i.e. > every 5 minutes).
The ASAP 2 study suggested that a safe level of low blood pressure occurs when only 1.44 mls 0.5% hyperbaric/normobaric spinal anaesthesia is administered, and the investigator has been using this amount (1.5mls) in Brighton since 2011.
Recently, it has become possible to transfer vital signs data from anaesthetic monitors to storage computers for medicolegal purposes (eg in Coroner's investigations - approximately 4000 people in the UK die annually within a month of hip fracture surgery).
However, analyzing such observational medicolegal data should also allow accurate description of how blood pressure changes around the time of surgery, and in patient groups that are normally excluded from prospective research (eg the very old, the very frail, people with dementia). By comparing this data to published national data from the ASAP 1 study, it should be possible to determine whether lower doses of spinal anaesthesia are linked with a lower rate of low blood pressure during surgery. By merging individuals' data with that held on the Brighton Hip Fracture Database, it should be possible to determine whether prevalence (and/or depth+duration of hypotension) are correlated with outcomes (survival, length of inpatient stay) after hip fracture repair.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip fracture cohort | – | Procedure: Intrathecal anaesthesiaGender, Age, Racial and Ethnic Origin of Subjects Male and female adults over the age of 18 years; all origins, all races will be included. Inclusion/exclusion criteria as below |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People undergoing surgical hip fracture repair (hemiarthoplasty, dynamic hip screw, cortical screws, proximal femoral nail) administered spinal anaesthesia for whom contemporaneous vital signs (including blood pressure, heart rate, oxygen saturation, breathing rate) have been stored in an anonymised, double password-protected database held on secure computers at Princess Royal Hospital, Hayward's Heath (E. Sussex).
Key inclusion criteria (2 listed)
- Adults (over 18 years) who have sustained a unilateral hip fracture and received surgery (hemiarthroplasty, dynamic hip screw, cortical screws, proximal femoral nail) under low dose spinal anaesthesia (1.3 mls 0.5% hyperbaric bupivacaine) after fascia iliaca block + sedation, administered by the Chief Investigator (CI) between 3rd March, 2017 and 1st January, 2020 at the Princess Royal Hospital, Hayward's Heath (E Sussex).
- For whom crude vital signs data have been stored in pseudo-anonymised electronic form on secure hospital computers, for medico-legal reference
Key exclusion criteria (4 listed)
- People with hip fracture receiving conservative management during the study period;
- People with hip fracture requiring total hip arthroplasty (for whom larger volumes of spinal anaesthesia are used);
- People with hip fracture administered spinal anaesthesia other than 1.3 mls 0.5% hyperbaric bupivacaine;
- People meeting inclusion criteria for whom vital signs could not be stored electronically due to equipment failure.
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 |
|---|---|---|
| Intrathecal anaesthesiaLow dose 0.5% hyperbaric bupivacaine (1.3mls, 0.65mg) intrathecal anaesthesia. | Procedure or surgery | Hip fracture cohort |
Primary outcome
Cohort mean (SD) mean non-invasive blood pressure (MAP)
Time frame: Occurring during the 2 hour duration (approximately) of anaesthesia and surgery for each patient
Taken at 2 minute intervals peri-operatively for each patient
5 secondary outcomes
The cohort prevalence of hypotension
Time frame: During anaesthesia and surgery
Mean depth x duration area under curve product for cohort hypotension after low dose spinal anaesthesia for hip fracture surgery
Time frame: During anaesthesia and surgery
Quantification of cohort systolic and mean arterial blood pressure changes before spinal administration
Time frame: During anaesthesia and surgery
Effective cohort duration of spinal anaesthesia
Time frame: During anaesthesia and surgery
Correlations between individual (a) hypotension (b) hypotension depth/duration product and outcomes (death at 30 days, length of stay in hospital)
Time frame: During anaesthesia and surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Results publicationNational Hip Fracture Database. 2019 Report. https://www.nhfd.co.uk/20/hipfractureR.nsf/docs/2019Report
- Results publicationNational Hip Fracture Database. Anaesthesia Sprint Audit of Practice (ASAP). 2014. https://www.nhfd.co.uk/20/hipfractureR.nsf/vwContent/asapReport/$file/onlineASAP.pdf
- Results publication: PubMed 26940645White SM, Moppett IK, Griffiths R, Johansen A, Wakeman R, Boulton C, Plant F, Williams A, Pappenheim K, Majeed A, Currie CT, Grocott MP. Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice (ASAP-2). Anaesthesia. 2016 May;71(5):506-14. doi: 10.1111/anae.13415. Epub 2016 Mar 4.
- Results publication: PubMed 33289066Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.
- Results publication: PubMed 10638892Ben-David B, Frankel R, Arzumonov T, Marchevsky Y, Volpin G. Minidose bupivacaine-fentanyl spinal anesthesia for surgical repair of hip fracture in the aged. Anesthesiology. 2000 Jan;92(1):6-10. doi: 10.1097/00000542-200001000-00007.
- Results publication: PubMed 16632842Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
- Results publication: PubMed 28093744White SM, Pateman J. A method of recording electronic anaesthetic monitor data for research. Anaesthesia. 2017 Feb;72(2):267-269. doi: 10.1111/anae.13794. No abstract available.
- Results publication: PubMed 19735395White SM, Rashid N, Chakladar A. An analysis of renal dysfunction in 1511 patients with fractured neck of femur: the implications for peri-operative analgesia. Anaesthesia. 2009 Oct;64(10):1061-5. doi: 10.1111/j.1365-2044.2009.06012.x.
- Derived from this study: PubMed 38390395White SM. A retrospective, observational, single-centre, cohort database analysis of the haemodynamic effects of low-dose spinal anaesthesia for hip fracture surgery. BJA Open. 2024 Feb 17;9:100261. doi: 10.1016/j.bjao.2024.100261. eCollection 2024 Mar.
- Individual participant dataSharing planned: Yes. On application to PI
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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.
Stu White, FRCA BSc MA principal investigator
Consultant Anaesthetist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Royal Sussex County Hospital at 1 site in United Kingdom.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2023. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Cohort mean (SD) mean non-invasive blood pressure (MAP) (time frame: Occurring during the 2 hour duration (approximately) of anaesthesia and surgery for each patient). 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 NCT05799300, which also lists 9 linked publications.
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 5 Apr 2023.