Postoperative Cognitive DysfunctionNCT03963063
Neurological Effects of Goal-directed Fluid Therapy in Beach Chair Position Shoulder Surgery
A study testing Goal-directed fluid therapy and Non goal-directed fluid therapy in people with Postoperative Cognitive Dysfunction and Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Patients receiving beach chair position shoulder surgery are vulnerable to perioperative cerebral desaturation, which is reported to be a risk factor for postoperative cognitive dysfunction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Anesthesia
- What is being tested?
- Goal-directed fluid therapy and Non goal-directed fluid therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jun 2019to 31 Mar 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving scheduled beach chair position shoulder surgery
Who cannot join
- pregnant women
- patients in intensive care units
- patients with respiratory failure [forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 70 % and FEV1 < 50%]
- patients with heart failure(NYHA score =III、IV)
- patients with chronic kidney disease (eGFR< 60 ml.min-1.1.73m-2)
- patients with liver failure
- patients with ongoing infection
- patients allergic to voluven
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Efficacy of Perioperative Goal-directed Fluid Therapy in Preventing Cerebral Desaturation and Postoperative Cognitive Dysfunction After Beach Chair Position Shoulder Surgery
Patients receiving beach chair position shoulder surgery are vulnerable to perioperative cerebral desaturation, which is reported to be a risk factor for postoperative cognitive dysfunction. Investigators design this study to test the efficacy of perioperative goal-directed therapy in preventing cerebral desaturation and postoperative cognitive dysfunction in patients receiving beach chair position shoulder surgery.
- Conditions
- Postoperative Cognitive Dysfunction, Anesthesia
- Being tested
- Goal-directed fluid therapy, Non goal-directed fluid therapy
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed fluid therapyProcedure or surgery
Patients in the group will follow our mini-fluid challenge test goal-directed therapy protocol, maintaining:
- individualized optimised stroke volume by mini-fluid challenge first
- keep mean arterial pressure ≧65 mmHg
- keep systolic blood pressure ≦140 mmHg
- keep cardiac index ≧ 2.5 L/min/cm2
Non goal-directed fluid therapyProcedure or surgery
Patients in the group will receive standard perioperative care at the discretion of care-giving anesthesiologist, maintaining:
- keep mean arterial pressure ≧65 mmHg
- keep systolic blood pressure ≦140 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Non Goal-directed Care Group | Active comparator | Not described Receives: Procedure: Non goal-directed fluid therapy |
| Goal-directed Care Group | Experimental | Not described Receives: Procedure: Goal-directed fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of cerebral desaturation events
patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the duration of cerebral desaturation events
Measured: 3 hours
Secondary outcomes (2)
incidence of cerebral desaturation events
patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the incidence of cerebral desaturation events
Measured: 3 hours
postoperative cognitive dysfunction assessed by the Taiwan version of questionnaire Qmci
Qmci is a screening assessment developed to detect mild cognitive impairment. It's a 100-point test administered in approximately 10 minutes. A score of 60 or over is considered to be normal. The validity of the Taiwan version of Qmci has been established.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start27 Jun 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Ph.D., Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963063
- Sponsor's protocol ID
- 201903017RINB
- Status last verified
- Oct 2020
- First submitted
- 21 May 2019
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19.
PubMed 30348620Rappold T, Laflam A, Hori D, Brown C, Brandt J, Mintz CD, Sieber F, Gottschalk A, Yenokyan G, Everett A, Hogue CW. Evidence of an association between brain cellular injury and cognitive decline after non-cardiac surgery. Br J Anaesth. 2016 Jan;116(1):83-9. doi: 10.1093/bja/aev415.
PubMed 26675953Meex I, Vundelinckx J, Buyse K, Deburggraeve F, De Naeyer S, Desloovere V, Anne L, Truijen J, Vander Laenen M, Heylen R, De Deyne C, Jans F. Cerebral tissue oxygen saturation values in volunteers and patients in the lateral decubitus and beach chair positions: a prospective observational study. Can J Anaesth. 2016 May;63(5):537-43. doi: 10.1007/s12630-016-0604-3. Epub 2016 Feb 4.
PubMed 26846619Aguirre J, Borgeat A, Trachsel T, Cobo Del Prado I, De Andres J, Buhler P. Cerebral oxygenation in patients undergoing shoulder surgery in beach chair position: comparing general to regional anesthesia and the impact on neurobehavioral outcome. Rev Esp Anestesiol Reanim. 2014 Feb;61(2):64-72. doi: 10.1016/j.redar.2013.08.002. Epub 2013 Oct 9.
PubMed 24119783Aguirre JA, Etzensperger F, Brada M, Guzzella S, Saporito A, Blumenthal S, Buhler P, Borgeat A. The beach chair position for shoulder surgery in intravenous general anesthesia and controlled hypotension: Impact on cerebral oxygenation, cerebral blood flow and neurobehavioral outcome. J Clin Anesth. 2019 Mar;53:40-48. doi: 10.1016/j.jclinane.2018.09.035. Epub 2018 Oct 4.
PubMed 30292739Ni C, Xu T, Li N, Tian Y, Han Y, Xue Q, Li M, Guo X. Cerebral oxygen saturation after multiple perioperative influential factors predicts the occurrence of postoperative cognitive dysfunction. BMC Anesthesiol. 2015 Oct 26;15:156. doi: 10.1186/s12871-015-0117-6.
PubMed 26503361Zhang N, Liang M, Zhang DD, Xiao YR, Li YZ, Gao YG, Cai HD, Lin XZ, Lin CZ, Zeng K, Wu XD. Effect of goal-directed fluid therapy on early cognitive function in elderly patients with spinal stenosis: A Case-Control Study. Int J Surg. 2018 Jun;54(Pt A):201-205. doi: 10.1016/j.ijsu.2018.04.007. Epub 2018 Apr 17.
PubMed 29678619Lee CT, Lin CP, Chan KC, Wu YL, Teng HC, Wu CY. Effects of Goal-Directed Hemodynamic Therapy Using a Noninvasive Finger-Cuff Monitoring Device on Intraoperative Cerebral Oxygenation and Early Delayed Neurocognitive Recovery in Patients Undergoing Beach Chair Position Shoulder Surgery: A Randomized Controlled Trial. Anesth Analg. 2023 Feb 1;136(2):355-364. doi: 10.1213/ANE.0000000000006200. Epub 2022 Sep 22.
PubMed 36135341
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perioperative Goal-directed Fluid Therapy in Preventing Cerebral Desaturation and Postoperative Cognitive Dysfunction After Beach Chair Position Shoulder Surgery
- ClinicalTrials.gov ID
- NCT03963063
- Acronym / sponsor ID
- 201903017RINB
- Conditions
- Postoperative Cognitive Dysfunction, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 24 May 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.
Patients receiving beach chair position shoulder surgery are vulnerable to perioperative cerebral desaturation, which is reported to be a risk factor for postoperative cognitive dysfunction. Investigators design this study to test the efficacy of perioperative goal-directed therapy in preventing cerebral desaturation and postoperative cognitive dysfunction in patients receiving beach chair position shoulder surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Goal-directed Care Group | Active comparator | Procedure: Non goal-directed fluid therapy |
| Goal-directed Care Group | Experimental | Procedure: Goal-directed fluid therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving scheduled beach chair position shoulder surgery
Key exclusion criteria (8 listed)
- pregnant women
- patients in intensive care units
- patients with respiratory failure [forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 70 % and FEV1 < 50%]
- patients with heart failure(NYHA score =III、IV)
- patients with chronic kidney disease (eGFR< 60 ml.min-1.1.73m-2)
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 |
|---|---|---|
| Goal-directed fluid therapyPatients in the group will follow our mini-fluid challenge test goal-directed therapy protocol, maintaining: * individualized optimised stroke volume by mini-fluid challenge first * keep mean arterial pressure ≧65 mmHg * keep systolic blood pressure ≦140 mmHg * keep cardiac index ≧ 2.5 L/min/cm2 | Procedure or surgery | Goal-directed Care Group |
| Non goal-directed fluid therapyPatients in the group will receive standard perioperative care at the discretion of care-giving anesthesiologist, maintaining: * keep mean arterial pressure ≧65 mmHg * keep systolic blood pressure ≦140 mmHg | Procedure or surgery | Non Goal-directed Care Group |
Primary outcome
duration of cerebral desaturation events
Time frame: 3 hours
patients will be monitored with bilateral cerebral oxymetry, and investigators will compare the duration of cerebral desaturation events
2 secondary outcomes
incidence of cerebral desaturation events
Time frame: 3 hours
postoperative cognitive dysfunction assessed by the Taiwan version of questionnaire Qmci
Time frame: 3 days
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 21 Jan 2022.
- Background: PubMed 30348620Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19.
- Background: PubMed 26675953Rappold T, Laflam A, Hori D, Brown C, Brandt J, Mintz CD, Sieber F, Gottschalk A, Yenokyan G, Everett A, Hogue CW. Evidence of an association between brain cellular injury and cognitive decline after non-cardiac surgery. Br J Anaesth. 2016 Jan;116(1):83-9. doi: 10.1093/bja/aev415.
- Results publication: PubMed 26846619Meex I, Vundelinckx J, Buyse K, Deburggraeve F, De Naeyer S, Desloovere V, Anne L, Truijen J, Vander Laenen M, Heylen R, De Deyne C, Jans F. Cerebral tissue oxygen saturation values in volunteers and patients in the lateral decubitus and beach chair positions: a prospective observational study. Can J Anaesth. 2016 May;63(5):537-43. doi: 10.1007/s12630-016-0604-3. Epub 2016 Feb 4.
- Results publication: PubMed 24119783Aguirre J, Borgeat A, Trachsel T, Cobo Del Prado I, De Andres J, Buhler P. Cerebral oxygenation in patients undergoing shoulder surgery in beach chair position: comparing general to regional anesthesia and the impact on neurobehavioral outcome. Rev Esp Anestesiol Reanim. 2014 Feb;61(2):64-72. doi: 10.1016/j.redar.2013.08.002. Epub 2013 Oct 9.
- Results publication: PubMed 30292739Aguirre JA, Etzensperger F, Brada M, Guzzella S, Saporito A, Blumenthal S, Buhler P, Borgeat A. The beach chair position for shoulder surgery in intravenous general anesthesia and controlled hypotension: Impact on cerebral oxygenation, cerebral blood flow and neurobehavioral outcome. J Clin Anesth. 2019 Mar;53:40-48. doi: 10.1016/j.jclinane.2018.09.035. Epub 2018 Oct 4.
- Results publication: PubMed 26503361Ni C, Xu T, Li N, Tian Y, Han Y, Xue Q, Li M, Guo X. Cerebral oxygen saturation after multiple perioperative influential factors predicts the occurrence of postoperative cognitive dysfunction. BMC Anesthesiol. 2015 Oct 26;15:156. doi: 10.1186/s12871-015-0117-6.
- Results publication: PubMed 29678619Zhang N, Liang M, Zhang DD, Xiao YR, Li YZ, Gao YG, Cai HD, Lin XZ, Lin CZ, Zeng K, Wu XD. Effect of goal-directed fluid therapy on early cognitive function in elderly patients with spinal stenosis: A Case-Control Study. Int J Surg. 2018 Jun;54(Pt A):201-205. doi: 10.1016/j.ijsu.2018.04.007. Epub 2018 Apr 17.
- Derived from this study: PubMed 36135341Lee CT, Lin CP, Chan KC, Wu YL, Teng HC, Wu CY. Effects of Goal-Directed Hemodynamic Therapy Using a Noninvasive Finger-Cuff Monitoring Device on Intraoperative Cerebral Oxygenation and Early Delayed Neurocognitive Recovery in Patients Undergoing Beach Chair Position Shoulder Surgery: A Randomized Controlled Trial. Anesth Analg. 2023 Feb 1;136(2):355-364. doi: 10.1213/ANE.0000000000006200. Epub 2022 Sep 22.
- Individual participant dataSharing planned: No
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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.
Chun-Yu Wu, Ph.D. study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed fluid therapy and Non goal-directed fluid therapy in people with Postoperative Cognitive Dysfunction and Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 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 21 Jan 2022. 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 Taiwan. 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?
duration of cerebral desaturation events (time frame: 3 hours). 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 NCT03963063, which also lists 8 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 21 Jan 2022.