Healthy VolunteersDANA1NCT04125121
Neuroplasticity Induced by General Anaesthesia
A study testing Sevoflurane-propofol in people with Healthy Volunteers and General Anaesthesia, run by Signe Sloth Madsen at 2 sites in Denmark.
Trial summary
The aim of this study is to use magnetic resonance imaging to explore and compare possible de novo neuroplastic changes induced by the isolated effects of the hypnotic agents sevoflurane and propofol, respectively. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, General Anaesthesia, Neuroplasticity
- What is being tested?
- Sevoflurane-propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 26 Sep 2019to 13 Aug 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥18 and ≤35.
- Healthy individual.
- BMI ≥18 kg/m2 and ≤30kg/m2.
- Normal electrocardiogram (ECG).
- Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse.
- American Society of Anaesthesiologists (ASA) class 1.
Show all 11Show fewer
- Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation). See appendix for details.
- Right-handed.
- Female participants must use safe contraceptives (hormonal or mechanical, including intrauterine devices).
- Speaks and understand Danish.
- Provides oral and written informed consent.
Who cannot join
- Contraindications to MRI.
- Left-handedness or ambidexterity.
- History of complications to general anaesthesia, including malignant hyperthermia.
- Family history of malignant hyperthermia.
- Known incident of malignant hyperthermia or any unexplained complication to general anaesthesia among close relatives.
- Allergy to any kind of medication or material to which the volunteer could be exposed during this study.
Show all 33Show fewer
- History of serious illness.
- History of cancer, immune disease, autoimmune disease, chronic pain or neurological / psychiatric illness.
- Major trauma or head trauma with any symptoms present at the time of inclusion.
- Surgery less than six weeks prior to the study period.
- Infection (with fever) less than two weeks prior to or during the study sessions.
- Daily use of any medication (not counting contraceptives).
- Consumed anti-depressants during the last 30 days before study days.
- Weakly intake of >21 (for females >14) units of alcohol.
- Heavy intake of caffeine (> 5 cups/day).
- Smoking during the last 30 days before study days.
- Substance abuse (assessed by the investigator).
- Pregnancy
- Reflux or dyspepsia.
- Poor dental status or oral health.
- Expected or suspected difficult airway.
- Declines receiving information regarding accidental pathological findings during MRI scans of the brain.
- Cannot cooperate to tests.
- Otherwise judged unfit for participation by the investigator.
- Any of the above-mentioned exclusion criteria.
- Major trauma or head trauma during the study period.
- Surgery during the study period.
- Infection (with fever) during the study period.
- Consumption of more than 3 units of alcohol within 24 hours before each study day (intervention day or MRI scan day)
- Consumed analgesics within 3 days before each study day
- Consumed anti-histamines less than 48 hours before each study day
- Intake of caffeine 12 h prior to each study day
- Smoking
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Neuroanaesthesiology
Glostrup Municipality, Capital Region, 2600
Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup
Glostrup Municipality, Capital Region, 2600
About this study
The aim of this study is to use magnetic resonance imaging to explore and compare possible de novo neuroplastic changes induced by the isolated effects of the hypnotic agents sevoflurane and propofol, respectively. In addition, to explore possible associations between neuroplastic changes and clinical and/or biochemical outcomes. It is a randomised, cross-over, single blinded clinical study. N = 30. Female:male ratio 1:1.
Read the detailed description
Background
In the perioperative period, severe changes can be observed in the endocrine, immune, and nervous system. These changes are called the surgical stress response. Clinically, this can be observed as increased pain response and disturbances in the circadian rhythm, memory, cognitive and executive functions, and may lead to post-operative delirium. The post-operative cognitive dysfunction is associated with increased mortality and risk of prematurely leaving occupation. Post-operative delirium with fluctuating levels of attention and consciousness is a serious condition associated with poor outcome, including longer hospitalisation and increased early mortality.
General anaesthesia may contribute to the surgical stress response. Some data indicate that general anaesthesia per se can cause alterations and disturbances in the brain such as sleep and circadian disturbances. Recent evidence suggests that anaesthetic agents may impair neurogenesis and cause memory impairment. In addition, inhalation anaesthesia may result in more cerebral disturbances compared to total intravenous anaesthesia (TIVA). In this study, we will isolate the effects of the two primary hypnotic agents used in general anaesthesia, sevoflurane and propofol, without the interactions and confounders of polypharmacy and varying levels of disease among a surgical population.
Materials
The study consists of two study sessions. In each study session magnetic resonance imaging (MRI) scans will be obtained before and after general anaesthesia, and in addition after one and eight days.
The following imaging modalities will be employed: (i) T1-weighted 3D anatomy (T1w3D), (ii) Diffusion Tensor Imaging (DTI), (iii) resting state functional MRI (rsfMRI). The MRI scans will be supplemented with cognitive testing, sleep evaluation and blood sampling. Thus, the set-up for each volunteer will be:
Session one:
Day 0: MRI 1, cognitive testing, questionnaires, and blood sampling. General anaesthesia (maintenance phase with sevoflurane OR propofol according to randomisation), and post-anaesthesia care. MRI 2 and repeated cognitive testing, questionnaires, and blood sampling.
Day +1: MRI 3, cognitive testing, questionnaires, and blood sampling.
Day +8: MRI 4, cognitive testing, and questionnaires.
Session two: Identical to session one, except the volunteer will receive the remaining type of general anaesthesia (sevoflurane or propofol, opposite to session one).
Data evaluation will be conducted with assessor blinded to anaesthesia type.
- Conditions
- Healthy Volunteers, General Anaesthesia, Neuroplasticity
- Being tested
- Sevoflurane-propofol
- Keywords
- Neuroplasticity, Neuroplastic changes, General anaesthesia, Magnetic resonance imaging, Sevoflurane, Propofol, Healthy volunteers, Consciousness, Cognitive, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane-propofolDrug
Also called Propofol-sevoflurane
General anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane-Propofol | Active comparator | Session one: Sevoflurane as maintenance anaesthetic during general anaesthesia.
Session two: Propofol as maintenance anaesthetic during general anaesthesia. Receives: Drug: Sevoflurane-propofol |
| Propofol-Sevoflurane | Active comparator | Session one: Propofol as maintenance anaesthetic during general anaesthesia.
Session two: Sevoflurane as maintenance anaesthetic during general anaesthesia. Receives: Drug: Sevoflurane-propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in T1w3D
Volume and morphology of selected brain regions and anatomical structures as recorded by T1w3D anatomy MRI.
Measured: 8 days
Changes in DTI
White matter microstructure as measured using Diffusion Tensor Imaging (DTI)
Measured: 8 days
Secondary outcomes (3)
Changes in rsfMRI
Differences in resting state functional MRI induced by general anaesthesia
Measured: 8 days
Changes in fatigue
Differences in severity and characteristics of fatigue related to general anaesthesia, as measured by Multidimensional Fatigue Inventory (MFI-20, a scale of 0-5 in each of 20 questions, with higher scores indicating more fatigue).
Measured: 8 days
Cognitive performance
Changes in cognitive function related to general anaesthesia, measured with a combination of Test of Attentional Performance, Paced Auditory Serial Addition Test and Conners Continuous Performance Test.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start26 Sep 2019
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (65)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomisation to one of two options in session 1: sevoflurane or propofol. In session 2, the remaining option is administered.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Signe Sloth Madsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Signe Sloth Madsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Signe Madsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125121
- Sponsor's protocol ID
- H-18028925
- Acronym
- DANA1
- Status last verified
- Aug 2021
- First submitted
- 10 Oct 2019
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The responsible investigators will consider data sharing, considered compliance with General Data Protection Regulation (GDPR) regulations and data sharing agreement.
Publications
Miller G. Miller's Anesthesia. 2015 ed. Philadelphia: Elsevier Saunders; 2015.
Campagna JA, Miller KW, Forman SA. Mechanisms of actions of inhaled anesthetics. N Engl J Med. 2003 May 22;348(21):2110-24. doi: 10.1056/NEJMra021261. No abstract available.
PubMed 12761368Ishizawa Y. Mechanisms of anesthetic actions and the brain. J Anesth. 2007;21(2):187-99. doi: 10.1007/s00540-006-0482-x. Epub 2007 May 30.
PubMed 17458649Vanlersberghe C, Camu F. Propofol. Handb Exp Pharmacol. 2008;(182):227-52. doi: 10.1007/978-3-540-74806-9_11.
PubMed 18175094Dunnet JM, Prys-Roberts C, Holland DE, Browne BL. Propofol infusion and the suppression of consciousness: dose requirements to induce loss of consciousness and to suppress response to noxious and non-noxious stimuli. Br J Anaesth. 1994 Jan;72(1):29-34. doi: 10.1093/bja/72.1.29.
PubMed 8110545Forrest FC, Tooley MA, Saunders PR, Prys-Roberts C. Propofol infusion and the suppression of consciousness: the EEG and dose requirements. Br J Anaesth. 1994 Jan;72(1):35-41. doi: 10.1093/bja/72.1.35.
PubMed 8110547Casati A, Fanelli G, Casaletti E, Colnaghi E, Cedrati V, Torri G. Clinical assessment of target-controlled infusion of propofol during monitored anesthesia care. Can J Anaesth. 1999 Mar;46(3):235-9. doi: 10.1007/BF03012602.
PubMed 10210047Sukhotinsky I, Zalkind V, Lu J, Hopkins DA, Saper CB, Devor M. Neural pathways associated with loss of consciousness caused by intracerebral microinjection of GABA A-active anesthetics. Eur J Neurosci. 2007 Mar;25(5):1417-36. doi: 10.1111/j.1460-9568.2007.05399.x.
PubMed 17425568Miller G. What is the biological basis of consciousness? Science. 2005 Jul 1;309(5731):79. doi: 10.1126/science.309.5731.79. No abstract available.
PubMed 15994525Schneider G, Kochs EF. The search for structures and mechanisms controlling anesthesia-induced unconsciousness. Anesthesiology. 2007 Aug;107(2):195-8. doi: 10.1097/01.anes.0000271869.27956.d1. No abstract available.
PubMed 17667560Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.
PubMed 21190458Herling SF, Dreijer B, Wrist Lam G, Thomsen T, Moller AM. Total intravenous anaesthesia versus inhalational anaesthesia for adults undergoing transabdominal robotic assisted laparoscopic surgery. Cochrane Database Syst Rev. 2017 Apr 4;4(4):CD011387. doi: 10.1002/14651858.CD011387.pub2.
PubMed 28374886Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.
PubMed 19225398Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.
PubMed 20664045Inouye SK, Marcantonio ER, Kosar CM, Tommet D, Schmitt EM, Travison TG, Saczynski JS, Ngo LH, Alsop DC, Jones RN. The short-term and long-term relationship between delirium and cognitive trajectory in older surgical patients. Alzheimers Dement. 2016 Jul;12(7):766-75. doi: 10.1016/j.jalz.2016.03.005. Epub 2016 Apr 18.
PubMed 27103261
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity Induced by General Anaesthesia
- ClinicalTrials.gov ID
- NCT04125121
- Acronym / sponsor ID
- DANA1 / H-18028925
- Conditions
- Healthy Volunteers, General Anaesthesia, Neuroplasticity
- Keywords
- Neuroplasticity, Neuroplastic changes, General anaesthesia, Magnetic resonance imaging, Sevoflurane, Propofol, Healthy volunteers, Consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Signe Sloth MadsenUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 14 Oct 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.
The aim of this study is to use magnetic resonance imaging to explore and compare possible de novo neuroplastic changes induced by the isolated effects of the hypnotic agents sevoflurane and propofol, respectively. In addition, to explore possible associations between neuroplastic changes and clinical and/or biochemical outcomes. It is a randomised, cross-over, single blinded clinical study. N = 30. Female:male ratio 1:1.
Detailed description
Background
In the perioperative period, severe changes can be observed in the endocrine, immune, and nervous system. These changes are called the surgical stress response. Clinically, this can be observed as increased pain response and disturbances in the circadian rhythm, memory, cognitive and executive functions, and may lead to post-operative delirium. The post-operative cognitive dysfunction is associated with increased mortality and risk of prematurely leaving occupation. Post-operative delirium with fluctuating levels of attention and consciousness is a serious condition associated with poor outcome, including longer hospitalisation and increased early mortality.
General anaesthesia may contribute to the surgical stress response. Some data indicate that general anaesthesia per se can cause alterations and disturbances in the brain such as sleep and circadian disturbances. Recent evidence suggests that anaesthetic agents may impair neurogenesis and cause memory impairment. In addition, inhalation anaesthesia may result in more cerebral disturbances compared to total intravenous anaesthesia (TIVA). In this study, we will isolate the effects of the two primary hypnotic agents used in general anaesthesia, sevoflurane and propofol, without the interactions and confounders of polypharmacy and varying levels of disease among a surgical population.
Materials
The study consists of two study sessions. In each study session magnetic resonance imaging (MRI) scans will be obtained before and after general anaesthesia, and in addition after one and eight days.
The following imaging modalities will be employed: (i) T1-weighted 3D anatomy (T1w3D), (ii) Diffusion Tensor Imaging (DTI), (iii) resting state functional MRI (rsfMRI). The MRI scans will be supplemented with cognitive testing, sleep evaluation and blood sampling. Thus, the set-up for each volunteer will be:
Session one:
Day 0: MRI 1, cognitive testing, questionnaires, and blood sampling. General anaesthesia (maintenance phase with sevoflurane OR propofol according to randomisation), and post-anaesthesia care. MRI 2 and repeated cognitive testing, questionnaires, and blood sampling.
Day +1: MRI 3, cognitive testing, questionnaires, and blood sampling.
Day +8: MRI 4, cognitive testing, and questionnaires.
Session two: Identical to session one, except the volunteer will receive the remaining type of general anaesthesia (sevoflurane or propofol, opposite to session one).
Data evaluation will be conducted with assessor blinded to anaesthesia type.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomisation to one of two options in session 1: sevoflurane or propofol. In session 2, the remaining option is administered.
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane-Propofol | Active comparator | Drug: Sevoflurane-propofolSession one: Sevoflurane as maintenance anaesthetic during general anaesthesia. Session two: Propofol as maintenance anaesthetic during general anaesthesia. |
| Propofol-Sevoflurane | Active comparator | Drug: Sevoflurane-propofolSession one: Propofol as maintenance anaesthetic during general anaesthesia. Session two: Sevoflurane as maintenance anaesthetic during general anaesthesia. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age ≥18 and ≤35.
- Healthy individual.
- BMI ≥18 kg/m2 and ≤30kg/m2.
- Normal electrocardiogram (ECG).
- Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse.
Key exclusion criteria (33 listed)
- Contraindications to MRI.
- Left-handedness or ambidexterity.
- History of complications to general anaesthesia, including malignant hyperthermia.
- Family history of malignant hyperthermia.
- Known incident of malignant hyperthermia or any unexplained complication to general anaesthesia among close relatives.
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 |
|---|---|---|
| Sevoflurane-propofolAlso: Propofol-sevofluraneGeneral anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol. | Drug | Propofol-Sevoflurane, Sevoflurane-Propofol |
Primary outcome
Changes in T1w3D
Time frame: 8 days
Volume and morphology of selected brain regions and anatomical structures as recorded by T1w3D anatomy MRI.
Changes in DTI
Time frame: 8 days
White matter microstructure as measured using Diffusion Tensor Imaging (DTI)
3 secondary outcomes
Changes in rsfMRI
Time frame: 8 days
Changes in fatigue
Time frame: 8 days
Cognitive performance
Time frame: 8 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 20 Aug 2021.
- BackgroundMiller G. Miller's Anesthesia. 2015 ed. Philadelphia: Elsevier Saunders; 2015.
- Background: PubMed 12761368Campagna JA, Miller KW, Forman SA. Mechanisms of actions of inhaled anesthetics. N Engl J Med. 2003 May 22;348(21):2110-24. doi: 10.1056/NEJMra021261. No abstract available.
- Background: PubMed 17458649Ishizawa Y. Mechanisms of anesthetic actions and the brain. J Anesth. 2007;21(2):187-99. doi: 10.1007/s00540-006-0482-x. Epub 2007 May 30.
- Background: PubMed 18175094Vanlersberghe C, Camu F. Propofol. Handb Exp Pharmacol. 2008;(182):227-52. doi: 10.1007/978-3-540-74806-9_11.
- Background: PubMed 8110545Dunnet JM, Prys-Roberts C, Holland DE, Browne BL. Propofol infusion and the suppression of consciousness: dose requirements to induce loss of consciousness and to suppress response to noxious and non-noxious stimuli. Br J Anaesth. 1994 Jan;72(1):29-34. doi: 10.1093/bja/72.1.29.
- Background: PubMed 8110547Forrest FC, Tooley MA, Saunders PR, Prys-Roberts C. Propofol infusion and the suppression of consciousness: the EEG and dose requirements. Br J Anaesth. 1994 Jan;72(1):35-41. doi: 10.1093/bja/72.1.35.
- Background: PubMed 10210047Casati A, Fanelli G, Casaletti E, Colnaghi E, Cedrati V, Torri G. Clinical assessment of target-controlled infusion of propofol during monitored anesthesia care. Can J Anaesth. 1999 Mar;46(3):235-9. doi: 10.1007/BF03012602.
- Background: PubMed 17425568Sukhotinsky I, Zalkind V, Lu J, Hopkins DA, Saper CB, Devor M. Neural pathways associated with loss of consciousness caused by intracerebral microinjection of GABA A-active anesthetics. Eur J Neurosci. 2007 Mar;25(5):1417-36. doi: 10.1111/j.1460-9568.2007.05399.x.
- Background: PubMed 15994525Miller G. What is the biological basis of consciousness? Science. 2005 Jul 1;309(5731):79. doi: 10.1126/science.309.5731.79. No abstract available.
- Background: PubMed 17667560Schneider G, Kochs EF. The search for structures and mechanisms controlling anesthesia-induced unconsciousness. Anesthesiology. 2007 Aug;107(2):195-8. doi: 10.1097/01.anes.0000271869.27956.d1. No abstract available.
- Background: PubMed 21190458Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.
- Background: PubMed 28374886Herling SF, Dreijer B, Wrist Lam G, Thomsen T, Moller AM. Total intravenous anaesthesia versus inhalational anaesthesia for adults undergoing transabdominal robotic assisted laparoscopic surgery. Cochrane Database Syst Rev. 2017 Apr 4;4(4):CD011387. doi: 10.1002/14651858.CD011387.pub2.
- American Society of Anesthesiologists Physical Status Classification SystemLink provided by the sponsor.
- Danish Medicines Information webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. The responsible investigators will consider data sharing, considered compliance with General Data Protection Regulation (GDPR) regulations and data sharing agreement.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
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.
Signe Madsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane-propofol in people with Healthy Volunteers and General Anaesthesia, run by Signe Sloth Madsen at 2 sites in Denmark.
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 11 inclusion and 33 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 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Changes in T1w3D (time frame: 8 days). The study lists 2 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 NCT04125121, which also lists 65 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 20 Aug 2021.