Head and Neck SurgeryNCT04963036
Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity
A study testing Entropy and NOL-Guided Goal Directed Anesthesia in people with Head and Neck Surgery and Maxillofacial Surgery, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Surgery, Maxillofacial Surgery
- What is being tested?
- Entropy and NOL-Guided Goal Directed Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jul 2021to Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- Elective high-risk head and neck or maxillo-facial surgery
Who cannot join
- Patient refusal
- Reduced ejection fraction below 40% and heart failure
- History of atrial Fibrillation, pulmonary embolism, recent cardioversion, recent cardiac ischemic episode, chronic hypotension, chronic kidney insufficiency (serum creatinine > 1.5)
- Septic state
- Baseline heart-rate < 50 or > 90 bpm
- History of psychiatric disease or medication
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Panayota Kapessidou, MD,PhD, +32.2.535 ext. 3750, pkapessi@ulb.ac.be
Medhi M'rini, MD, +32.2.535 ext. 3783, m.mrini@hotmail.com
About this study
Official title: Impact of Nociception Level (NOL)-Guided Remifentanil Infusion and Entropy-guided Propofol Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity A Prospective, Randomized, Controlled Trial.
The aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high risk patients. The investigator will also investigate the effects of guided anesthesia on postoperative Myocardial Injury in Non-cardiac Surgery (MINS) and Postoperative cognitive dysfunction (POCD), amongst other frequent postoperative complications, in this population.
- Conditions
- Head and Neck Surgery, Maxillofacial Surgery
- Being tested
- Entropy and NOL-Guided Goal Directed Anesthesia, Standard of Care Group (Entropy and blinded NOL)
- Keywords
- Nociception, Entropy, Analgesia, Goal Directed Anesthesia Therapy (GDAT), Remifentanil, Intraoperative Hypotension, Myocardial Injury in Non-Cardiac Surgery (MINS), Postoperative Cognitive Dysfunction (POCD)
- Medical subject headings
- Agnosia, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entropy and NOL-Guided Goal Directed AnesthesiaOther
Entropy-guided Anesthesia (Propofol infusion in order to maintain Entropy between 45 and 55) and NOL-guided Analgesia (Remifentanil infusion in order to maintain NOL-Index between 10 and 25).
Standard of Care Group (Entropy and blinded NOL)Other
Entropy-guided Anesthesia (Propofol infusion in order to obtain Entropy between 45 and 55) and Remifentanil infusion at the discretion of the anesthetist in charge, based on current practice: patient vitals (Heart Rate, Blood Pressure, Respiratory Rate…), movements, spontaneous breathing, experience....
In this group, nociception monitor screen will be concealed and the NOL index will not be available for guidance of remifentanil dosing).
| Study group | Role | What they receive |
|---|---|---|
| Entropy and NOL-Guided Goal Directed Anesthesia | Experimental | Not described Receives: Other: Entropy and NOL-Guided Goal Directed Anesthesia |
| Standard of Care Group (Entropy and blinded NOL) | Active comparator | Not described Receives: Other: Standard of Care Group (Entropy and blinded NOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of intraoperative hypotension
Occurrence of intraoperative hypotension is defined by at least 1 minute under the hypotension thresholds.
Moderate and Severe Hypotension are respectively defined as a Mean Blood Pressure <65 mmHg or <55 mmHg and <75 or <65 mmHg for patient with history of chronic hypertension
Measured: during surgery
Total Vasopressor Dose
Total Vasopressor Dose used throughout the intervention to maintain Arterial Pressure within a pre-defined individualized ranges (≥ 65 mmHg or ≥75 mmHg for patient with history of chronic hypertension, and ≤ 100 mmHg)
Measured: during surgery
Number of interventions to cure intraoperative hypotension
Number of vasopressor boli or vasopressor infusion dose adjustments
Measured: during surgery
Total Time under hypotension thresholds
Hypotension Thresholds ( <65 mmHg or < 75mmHg for patient with history of chronic hypertension)
Measured: during surgery
Secondary outcomes (10)
Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T)
Troponin T level measured before surgery, at end of surgery, 4 hours, 8 hours, 24 hours, 36 hours and 48 hours after surgery. The threshold is a postoperative concentration ≥ 20 ng/L with an increase from baseline of at least 5 ng/L, or a postoperative concentration ≥ 65 ng/L.
Measured: up to 48 hours after surgery
Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate)
Creatinin level measured before surgery, at end of surgery, 24 hours and 48 hours after surgery. The thresholds are defined by the Kidney Disease: Improving Global Outcomes (KDIGO) classification without the oliguria criteria.
Measured: up to 48 hours after surgery
Postoperative Cognitive Decline (POCD)
POCD will be evaluated by cognitive dysfunction battery tests (written Montreal Cognitive Assessment (MOCA) Test) at days 5,10, 15, hospital discharge, 3 and 6 postoperative months
Measured: up to 6 months after surgery
PostOperative Delirium (PO Delirium)
PO Delirium will be evaluated by the Confusion Assessment Method (CAM) at days 5, 10, 15, hospital discharge, 3 and 6 postoperative months
Measured: up to 6 months after surgery
Dosage of Stress Hormones
Adrenocorticotropic Hormone (ACTH) and Cortisol will be measured in blood samples at the end of surgery, at the arrival in the ICU and at 4 hours after surgery.
Measured: up to 4 hours after surgery
Dosage of Neuro-Inflammatory Markers
Interleukine-6 and Interleukine-8 will be measured in blood and saliva samples before surgery and during the postoperative period (4 hours, 24 hours and 48 hours after surgery).
Measured: up to 48 hours after surgery
Olfactory Function assessment as an indicator of Neuro-Inflammation
A rapid quantitative olfactory function test, the University of Pennsylvania Smell Identification -Test (UPSIT-Test) will be performed before surgery and during the postoperative period (4 hours, 24 hours and 48 hours after surgery).
Measured: up to 48 hours after surgery
Length of Intensive Unit Care (IUC) stay
Measured: up to 10 Days after surgery
Length of hospital stay
Measured: up to 15 Days after surgery
Adverse Event (blood loss, infection)
Measured: up to 15 Days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start28 Jul 2021
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Head and Neck SurgeryStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panayota Kapessidou, MD,PhD, Study director, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)Mehdi M'rini, MD, Principal investigator, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963036
- Sponsor's protocol ID
- B0762021210506
- Status last verified
- Jul 2021
- First submitted
- 14 Jun 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saugel B, Sessler DI. Perioperative Blood Pressure Management. Anesthesiology. 2021 Feb 1;134(2):250-261. doi: 10.1097/ALN.0000000000003610. No abstract available.
PubMed 33206118Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018 Jun;44(6):811-822. doi: 10.1007/s00134-018-5224-7. Epub 2018 Jun 4.
PubMed 29868971Ruetzler K, Khanna AK, Sessler DI. Myocardial Injury After Noncardiac Surgery: Preoperative, Intraoperative, and Postoperative Aspects, Implications, and Directions. Anesth Analg. 2020 Jul;131(1):173-186. doi: 10.1213/ANE.0000000000004567.
PubMed 31880630Krzych LJ, Pluta MP, Putowski Z, Czok M. Investigating Association between Intraoperative Hypotension and Postoperative Neurocognitive Disorders in Non-Cardiac Surgery: A Comprehensive Review. J Clin Med. 2020 Sep 30;9(10):3183. doi: 10.3390/jcm9103183.
PubMed 33008109Feng X, Hu J, Hua F, Zhang J, Zhang L, Xu G. The correlation of intraoperative hypotension and postoperative cognitive impairment: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Aug 5;20(1):193. doi: 10.1186/s12871-020-01097-5.
PubMed 32758153Greaves D, Psaltis PJ, Davis DHJ, Ross TJ, Ghezzi ES, Lampit A, Smith AE, Keage HAD. Risk Factors for Delirium and Cognitive Decline Following Coronary Artery Bypass Grafting Surgery: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2020 Nov 17;9(22):e017275. doi: 10.1161/JAHA.120.017275. Epub 2020 Nov 7.
PubMed 33164631Belrose JC, Noppens RR. Anesthesiology and cognitive impairment: a narrative review of current clinical literature. BMC Anesthesiol. 2019 Dec 27;19(1):241. doi: 10.1186/s12871-019-0903-7.
PubMed 31881996Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589Evered LA, Silbert BS. Postoperative Cognitive Dysfunction and Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):496-505. doi: 10.1213/ANE.0000000000003514.
PubMed 29889707Ledowski T. Monitoring nociception-getting 'there yet' might be easier with a road map. Br J Anaesth. 2017 Oct 1;119(4):716-717. doi: 10.1093/bja/aex277. No abstract available.
PubMed 29121306Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
PubMed 31047645De Jonckheere J, Bonhomme V, Jeanne M, Boselli E, Gruenewald M, Logier R, Richebe P. Physiological Signal Processing for Individualized Anti-nociception Management During General Anesthesia: a Review. Yearb Med Inform. 2015 Aug 13;10(1):95-101. doi: 10.15265/IY-2015-004.
PubMed 26293855Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
PubMed 26154185Meijer F, Honing M, Roor T, Toet S, Calis P, Olofsen E, Martini C, van Velzen M, Aarts L, Niesters M, Boon M, Dahan A. Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):1070-1078. doi: 10.1016/j.bja.2020.07.057. Epub 2020 Sep 17.
PubMed 32950246Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
PubMed 28973220
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nociception Level (NOL)-Guided Remifentanil Infusion and Entropy-guided Propofol Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity A Prospective, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT04963036
- Acronym / sponsor ID
- B0762021210506
- Conditions
- Head and Neck Surgery, Maxillofacial Surgery
- Keywords
- Nociception, Entropy, Analgesia, Goal Directed Anesthesia Therapy (GDAT), Remifentanil, Intraoperative Hypotension, Myocardial Injury in Non-Cardiac Surgery (MINS), Postoperative Cognitive Dysfunction (POCD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 15 Jul 2021 (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 aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high risk patients. The investigator will also investigate the effects of guided anesthesia on postoperative Myocardial Injury in Non-cardiac Surgery (MINS) and Postoperative cognitive dysfunction (POCD), amongst other frequent postoperative complications, in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entropy and NOL-Guided Goal Directed Anesthesia | Experimental | Other: Entropy and NOL-Guided Goal Directed Anesthesia |
| Standard of Care Group (Entropy and blinded NOL) | Active comparator | Other: Standard of Care Group (Entropy and blinded NOL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18
- Elective high-risk head and neck or maxillo-facial surgery
Key exclusion criteria (6 listed)
- Patient refusal
- Reduced ejection fraction below 40% and heart failure
- History of atrial Fibrillation, pulmonary embolism, recent cardioversion, recent cardiac ischemic episode, chronic hypotension, chronic kidney insufficiency (serum creatinine > 1.5)
- Septic state
- Baseline heart-rate < 50 or > 90 bpm
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 |
|---|---|---|
| Entropy and NOL-Guided Goal Directed AnesthesiaEntropy-guided Anesthesia (Propofol infusion in order to maintain Entropy between 45 and 55) and NOL-guided Analgesia (Remifentanil infusion in order to maintain NOL-Index between 10 and 25). | Other | Entropy and NOL-Guided Goal Directed Anesthesia |
| Standard of Care Group (Entropy and blinded NOL)Entropy-guided Anesthesia (Propofol infusion in order to obtain Entropy between 45 and 55) and Remifentanil infusion at the discretion of the anesthetist in charge, based on current practice: patient vitals (Heart Rate, Blood Pressure, Respiratory Rate…), movements, spontaneous breathing, experience.... In this group, nociception monitor screen will be concealed and the NOL index will not be available for guidance of remifentanil dosing). | Other | Standard of Care Group (Entropy and blinded NOL) |
Primary outcome
Occurrence of intraoperative hypotension
Time frame: during surgery
Occurrence of intraoperative hypotension is defined by at least 1 minute under the hypotension thresholds. Moderate and Severe Hypotension are respectively defined as a Mean Blood Pressure <65 mmHg or <55 mmHg and <75 or <65 mmHg for patient with history of chronic hypertension
Total Vasopressor Dose
Time frame: during surgery
Total Vasopressor Dose used throughout the intervention to maintain Arterial Pressure within a pre-defined individualized ranges (≥ 65 mmHg or ≥75 mmHg for patient with history of chronic hypertension, and ≤ 100 mmHg)
Number of interventions to cure intraoperative hypotension
Time frame: during surgery
Number of vasopressor boli or vasopressor infusion dose adjustments
Total Time under hypotension thresholds
Time frame: during surgery
Hypotension Thresholds ( <65 mmHg or < 75mmHg for patient with history of chronic hypertension)
10 secondary outcomes
Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T)
Time frame: up to 48 hours after surgery
Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate)
Time frame: up to 48 hours after surgery
Postoperative Cognitive Decline (POCD)
Time frame: up to 6 months after surgery
PostOperative Delirium (PO Delirium)
Time frame: up to 6 months after surgery
Dosage of Stress Hormones
Time frame: up to 4 hours after surgery
Dosage of Neuro-Inflammatory Markers
Time frame: up to 48 hours after surgery
Olfactory Function assessment as an indicator of Neuro-Inflammation
Time frame: up to 48 hours after surgery
Length of Intensive Unit Care (IUC) stay
Time frame: up to 10 Days after surgery
Length of hospital stay
Time frame: up to 15 Days after surgery
Adverse Event (blood loss, infection)
Time frame: up to 15 Days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Background: PubMed 33206118Saugel B, Sessler DI. Perioperative Blood Pressure Management. Anesthesiology. 2021 Feb 1;134(2):250-261. doi: 10.1097/ALN.0000000000003610. No abstract available.
- Background: PubMed 29868971Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018 Jun;44(6):811-822. doi: 10.1007/s00134-018-5224-7. Epub 2018 Jun 4.
- Background: PubMed 31880630Ruetzler K, Khanna AK, Sessler DI. Myocardial Injury After Noncardiac Surgery: Preoperative, Intraoperative, and Postoperative Aspects, Implications, and Directions. Anesth Analg. 2020 Jul;131(1):173-186. doi: 10.1213/ANE.0000000000004567.
- Background: PubMed 33008109Krzych LJ, Pluta MP, Putowski Z, Czok M. Investigating Association between Intraoperative Hypotension and Postoperative Neurocognitive Disorders in Non-Cardiac Surgery: A Comprehensive Review. J Clin Med. 2020 Sep 30;9(10):3183. doi: 10.3390/jcm9103183.
- Background: PubMed 32758153Feng X, Hu J, Hua F, Zhang J, Zhang L, Xu G. The correlation of intraoperative hypotension and postoperative cognitive impairment: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Aug 5;20(1):193. doi: 10.1186/s12871-020-01097-5.
- Background: PubMed 33164631Greaves D, Psaltis PJ, Davis DHJ, Ross TJ, Ghezzi ES, Lampit A, Smith AE, Keage HAD. Risk Factors for Delirium and Cognitive Decline Following Coronary Artery Bypass Grafting Surgery: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2020 Nov 17;9(22):e017275. doi: 10.1161/JAHA.120.017275. Epub 2020 Nov 7.
- Background: PubMed 31881996Belrose JC, Noppens RR. Anesthesiology and cognitive impairment: a narrative review of current clinical literature. BMC Anesthesiol. 2019 Dec 27;19(1):241. doi: 10.1186/s12871-019-0903-7.
- Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Background: PubMed 29889707Evered LA, Silbert BS. Postoperative Cognitive Dysfunction and Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):496-505. doi: 10.1213/ANE.0000000000003514.
- Background: PubMed 29121306Ledowski T. Monitoring nociception-getting 'there yet' might be easier with a road map. Br J Anaesth. 2017 Oct 1;119(4):716-717. doi: 10.1093/bja/aex277. No abstract available.
- Background: PubMed 31047645Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
- Background: PubMed 26293855De Jonckheere J, Bonhomme V, Jeanne M, Boselli E, Gruenewald M, Logier R, Richebe P. Physiological Signal Processing for Individualized Anti-nociception Management During General Anesthesia: a Review. Yearb Med Inform. 2015 Aug 13;10(1):95-101. doi: 10.15265/IY-2015-004.
- 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.
Panayota Kapessidou, MD,PhD study director
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Mehdi M'rini, MD principal investigator
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entropy and NOL-Guided Goal Directed Anesthesia in people with Head and Neck Surgery and Maxillofacial Surgery, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 6 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 15 Apr 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 Belgium. 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?
Contact Panayota Kapessidou, MD,PhD (+32.2.535 ext. 3750, pkapessi@ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of intraoperative hypotension (time frame: during surgery). The study lists 4 primary outcomes in all. 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 NCT04963036, which also lists 19 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 15 Apr 2022.