Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-26
Study Completion Date
2021-08-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation
NCT05615025
Anesthesia, General
Neuromuscular Transmission Disorders
COMPLETED
PHASE3
Neurobiological and Cognitive Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children
NCT03022240
Cognitive Change
Behavior
COMPLETED
PHASE3
Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals
NCT02914119
Neuromuscular Blockade
COMPLETED
Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan
NCT06218680
Emergence Agitation
NOT_YET_RECRUITING
NA
Sevoflurane, Propofol, Postoperative Pain
NCT01437462
Healthy Adults
Gynecological Disease
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Healthy Volunteers
General Anaesthesia
Neuroplasticity
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Randomisation to one of two options in session 1: sevoflurane or propofol. In session 2, the remaining option is administered.
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
The participants will not be present during randomisation. The participants will be anaesthetised when the investigational drug (maintenance anaesthetic) is administered, and will thus not be aware what type of anaesthesia is administered in which (otherwise identical) session.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sevoflurane-Propofol
Session one: Sevoflurane as maintenance anaesthetic during general anaesthesia.
Session two: Propofol as maintenance anaesthetic during general anaesthesia.
Group Type
ACTIVE_COMPARATOR
Sevoflurane-propofol
Intervention Type
DRUG
General anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol.
Propofol-Sevoflurane
Session one: Propofol as maintenance anaesthetic during general anaesthesia.
Session two: Sevoflurane as maintenance anaesthetic during general anaesthesia.
Group Type
ACTIVE_COMPARATOR
Sevoflurane-propofol
Intervention Type
DRUG
General anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sevoflurane-propofol
General anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol.
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Propofol-sevoflurane
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
* 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
* 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.
* 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.
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
35 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Signe Sloth Madsen
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Signe Sloth Madsen
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Signe Madsen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Neuroanaesthesiology
Glostrup Municipality, Capital Region, Denmark
Site Status
Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup
Glostrup Municipality, Capital Region, Denmark
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Denmark
References
Explore related publications, articles, or registry entries linked to this study.
Miller G. Miller's Anesthesia. 2015 ed. Philadelphia: Elsevier Saunders; 2015.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Ishizawa 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.
Reference Type
BACKGROUND
Vanlersberghe C, Camu F. Propofol. Handb Exp Pharmacol. 2008;(182):227-52. doi: 10.1007/978-3-540-74806-9_11.
Reference Type
BACKGROUND
Dunnet 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.
Reference Type
BACKGROUND
Forrest 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.
Reference Type
BACKGROUND
Casati 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.
Reference Type
BACKGROUND
Sukhotinsky 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.
Reference Type
BACKGROUND
Miller 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.
Reference Type
BACKGROUND
Schneider 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.
Reference Type
BACKGROUND
Brown 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.
Reference Type
BACKGROUND
Herling 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.
Reference Type
BACKGROUND
Steinmetz 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.
Reference Type
BACKGROUND
Witlox 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.
Reference Type
BACKGROUND
Inouye 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.
Reference Type
BACKGROUND
Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803.
Reference Type
BACKGROUND
Strom C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1(Suppl 1):35-44. doi: 10.1111/anae.12493.
Reference Type
BACKGROUND
Davis N, Lee M, Lin AY, Lynch L, Monteleone M, Falzon L, Ispahany N, Lei S. Postoperative cognitive function following general versus regional anesthesia: a systematic review. J Neurosurg Anesthesiol. 2014 Oct;26(4):369-76. doi: 10.1097/ANA.0000000000000120.
Reference Type
BACKGROUND
Lindqvist M, Schening A, Granstrom A, Bjorne H, Jakobsson JG. Cognitive recovery after ambulatory anaesthesia based on desflurane or propofol: a prospective randomised study. Acta Anaesthesiol Scand. 2014 Oct;58(9):1111-20. doi: 10.1111/aas.12381. Epub 2014 Aug 6.
Reference Type
BACKGROUND
Larsen B, Seitz A, Larsen R. Recovery of cognitive function after remifentanil-propofol anesthesia: a comparison with desflurane and sevoflurane anesthesia. Anesth Analg. 2000 Jan;90(1):168-74. doi: 10.1097/00000539-200001000-00035.
Reference Type
BACKGROUND
Jevtovic-Todorovic V, Absalom AR, Blomgren K, Brambrink A, Crosby G, Culley DJ, Fiskum G, Giffard RG, Herold KF, Loepke AW, Ma D, Orser BA, Planel E, Slikker W Jr, Soriano SG, Stratmann G, Vutskits L, Xie Z, Hemmings HC Jr. Anaesthetic neurotoxicity and neuroplasticity: an expert group report and statement based on the BJA Salzburg Seminar. Br J Anaesth. 2013 Aug;111(2):143-51. doi: 10.1093/bja/aet177. Epub 2013 May 30.
Reference Type
BACKGROUND
Schilling T, Kozian A, Senturk M, Huth C, Reinhold A, Hedenstierna G, Hachenberg T. Effects of volatile and intravenous anesthesia on the alveolar and systemic inflammatory response in thoracic surgical patients. Anesthesiology. 2011 Jul;115(1):65-74. doi: 10.1097/ALN.0b013e318214b9de.
Reference Type
BACKGROUND
Braz MG, Braz LG, Braz JR, Pierine DT, Correa CR, Ferreira AL, Carvalho LR, Yeum KJ, Salvadori DM. Comparison of oxidative stress in ASA physical status I patients scheduled for minimally invasive surgery under balanced or intravenous anesthesia. Minerva Anestesiol. 2013 Sep;79(9):1030-8. Epub 2013 Apr 18.
Reference Type
BACKGROUND
Crozier TA, Muller JE, Quittkat D, Sydow M, Wuttke W, Kettler D. Effect of anaesthesia on the cytokine responses to abdominal surgery. Br J Anaesth. 1994 Mar;72(3):280-5. doi: 10.1093/bja/72.3.280.
Reference Type
BACKGROUND
Bartal I, Melamed R, Greenfeld K, Atzil S, Glasner A, Domankevich V, Naor R, Beilin B, Yardeni IZ, Ben-Eliyahu S. Immune perturbations in patients along the perioperative period: alterations in cell surface markers and leukocyte subtypes before and after surgery. Brain Behav Immun. 2010 Mar;24(3):376-86. doi: 10.1016/j.bbi.2009.02.010. Epub 2009 Feb 28.
Reference Type
BACKGROUND
Ashburner J, Friston KJ. Voxel-based morphometry--the methods. Neuroimage. 2000 Jun;11(6 Pt 1):805-21. doi: 10.1006/nimg.2000.0582.
Reference Type
BACKGROUND
Ogawa S, Lee TM, Nayak AS, Glynn P. Oxygenation-sensitive contrast in magnetic resonance image of rodent brain at high magnetic fields. Magn Reson Med. 1990 Apr;14(1):68-78. doi: 10.1002/mrm.1910140108.
Reference Type
BACKGROUND
Brooks J, Tracey I. From nociception to pain perception: imaging the spinal and supraspinal pathways. J Anat. 2005 Jul;207(1):19-33. doi: 10.1111/j.1469-7580.2005.00428.x.
Reference Type
BACKGROUND
van den Heuvel MP, Hulshoff Pol HE. Exploring the brain network: a review on resting-state fMRI functional connectivity. Eur Neuropsychopharmacol. 2010 Aug;20(8):519-34. doi: 10.1016/j.euroneuro.2010.03.008. Epub 2010 May 14.
Reference Type
BACKGROUND
Pryor KO, Root JC, Mehta M, Stern E, Pan H, Veselis RA, Silbersweig DA. Effect of propofol on the medial temporal lobe emotional memory system: a functional magnetic resonance imaging study in human subjects. Br J Anaesth. 2015 Jul;115 Suppl 1(Suppl 1):i104-i113. doi: 10.1093/bja/aev038.
Reference Type
BACKGROUND
Quan X, Yi J, Ye TH, Tian SY, Zou L, Yu XR, Huang YG. Propofol and memory: a study using a process dissociation procedure and functional magnetic resonance imaging. Anaesthesia. 2013 Apr;68(4):391-9. doi: 10.1111/anae.12147.
Reference Type
BACKGROUND
Mhuircheartaigh RN, Rosenorn-Lanng D, Wise R, Jbabdi S, Rogers R, Tracey I. Cortical and subcortical connectivity changes during decreasing levels of consciousness in humans: a functional magnetic resonance imaging study using propofol. J Neurosci. 2010 Jul 7;30(27):9095-102. doi: 10.1523/JNEUROSCI.5516-09.2010.
Reference Type
BACKGROUND
Ni Mhuircheartaigh R, Warnaby C, Rogers R, Jbabdi S, Tracey I. Slow-wave activity saturation and thalamocortical isolation during propofol anesthesia in humans. Sci Transl Med. 2013 Oct 23;5(208):208ra148. doi: 10.1126/scitranslmed.3006007.
Reference Type
BACKGROUND
Bonhomme V, Fiset P, Meuret P, Backman S, Plourde G, Paus T, Bushnell MC, Evans AC. Propofol anesthesia and cerebral blood flow changes elicited by vibrotactile stimulation: a positron emission tomography study. J Neurophysiol. 2001 Mar;85(3):1299-308. doi: 10.1152/jn.2001.85.3.1299.
Reference Type
BACKGROUND
Pedersen JL, Lilleso J, Hammer NA, Werner MU, Holte K, Lacouture PG, Kehlet H. Thiopental and propofol affect different regions of the brain at similar pharmacologic effects. Anesth Analg. 2004 Aug;99(2):912-918. doi: 10.1213/01.ANE.0000131971.92180.DF.
Reference Type
BACKGROUND
Hofbauer RK, Fiset P, Plourde G, Backman SB, Bushnell MC. Dose-dependent effects of propofol on the central processing of thermal pain. Anesthesiology. 2004 Feb;100(2):386-94. doi: 10.1097/00000542-200402000-00031.
Reference Type
BACKGROUND
Sun X, Zhang H, Gao C, Zhang G, Xu L, Lv M, Chai W. Imaging the effects of propofol on human cerebral glucose metabolism using positron emission tomography. J Int Med Res. 2008 Nov-Dec;36(6):1305-10. doi: 10.1177/147323000803600618.
Reference Type
BACKGROUND
Schlunzen L, Juul N, Hansen KV, Cold GE. Regional cerebral blood flow and glucose metabolism during propofol anaesthesia in healthy subjects studied with positron emission tomography. Acta Anaesthesiol Scand. 2012 Feb;56(2):248-55. doi: 10.1111/j.1399-6576.2011.02561.x. Epub 2011 Oct 19.
Reference Type
BACKGROUND
Ramani R, Qiu M, Constable RT. Sevoflurane 0.25 MAC preferentially affects higher order association areas: a functional magnetic resonance imaging study in volunteers. Anesth Analg. 2007 Sep;105(3):648-55. doi: 10.1213/01.ane.0000277496.12747.29.
Reference Type
BACKGROUND
Qiu M, Ramani R, Swetye M, Rajeevan N, Constable RT. Anesthetic effects on regional CBF, BOLD, and the coupling between task-induced changes in CBF and BOLD: an fMRI study in normal human subjects. Magn Reson Med. 2008 Oct;60(4):987-96. doi: 10.1002/mrm.21759.
Reference Type
BACKGROUND
Lorenz IH, Kolbitsch C, Hormann C, Schocke M, Felber S, Zschiegner F, Hinteregger M, Kremser C, Pfeiffer KP, Benzer A. Subanesthetic concentration of sevoflurane increases regional cerebral blood flow more, but regional cerebral blood volume less, than subanesthetic concentration of isoflurane in human volunteers. J Neurosurg Anesthesiol. 2001 Oct;13(4):288-95. doi: 10.1097/00008506-200110000-00002.
Reference Type
BACKGROUND
Peltier SJ, Kerssens C, Hamann SB, Sebel PS, Byas-Smith M, Hu X. Functional connectivity changes with concentration of sevoflurane anesthesia. Neuroreport. 2005 Feb 28;16(3):285-8. doi: 10.1097/00001756-200502280-00017.
Reference Type
BACKGROUND
Kaisti KK, Langsjo JW, Aalto S, Oikonen V, Sipila H, Teras M, Hinkka S, Metsahonkala L, Scheinin H. Effects of sevoflurane, propofol, and adjunct nitrous oxide on regional cerebral blood flow, oxygen consumption, and blood volume in humans. Anesthesiology. 2003 Sep;99(3):603-13. doi: 10.1097/00000542-200309000-00015.
Reference Type
BACKGROUND
Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
Reference Type
BACKGROUND
Struys MM, Sahinovic M, Lichtenbelt BJ, Vereecke HE, Absalom AR. Optimizing intravenous drug administration by applying pharmacokinetic/pharmacodynamic concepts. Br J Anaesth. 2011 Jul;107(1):38-47. doi: 10.1093/bja/aer108. Epub 2011 May 30.
Reference Type
BACKGROUND
Sahinovic MM, Absalom AR, Struys MM. Administration and monitoring of intravenous anesthetics. Curr Opin Anaesthesiol. 2010 Dec;23(6):734-40. doi: 10.1097/ACO.0b013e3283404579.
Reference Type
BACKGROUND
Masui K, Upton RN, Doufas AG, Coetzee JF, Kazama T, Mortier EP, Struys MM. The performance of compartmental and physiologically based recirculatory pharmacokinetic models for propofol: a comparison using bolus, continuous, and target-controlled infusion data. Anesth Analg. 2010 Aug;111(2):368-79. doi: 10.1213/ANE.0b013e3181bdcf5b. Epub 2009 Oct 27.
Reference Type
BACKGROUND
Vestergaard MB, Lindberg U, Aachmann-Andersen NJ, Lisbjerg K, Christensen SJ, Rasmussen P, Olsen NV, Law I, Larsson HB, Henriksen OM. Comparison of global cerebral blood flow measured by phase-contrast mapping MRI with 15 O-H2 O positron emission tomography. J Magn Reson Imaging. 2017 Mar;45(3):692-699. doi: 10.1002/jmri.25442. Epub 2016 Sep 13.
Reference Type
BACKGROUND
American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: a report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2002 Mar;96(3):742-52. doi: 10.1097/00000542-200203000-00033. No abstract available.
Reference Type
BACKGROUND
Jain V, Langham MC, Wehrli FW. MRI estimation of global brain oxygen consumption rate. J Cereb Blood Flow Metab. 2010 Sep;30(9):1598-607. doi: 10.1038/jcbfm.2010.49. Epub 2010 Apr 21.
Reference Type
BACKGROUND
Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
Reference Type
BACKGROUND
Granert O, Peller M, Gaser C, Groppa S, Hallett M, Knutzen A, Deuschl G, Zeuner KE, Siebner HR. Manual activity shapes structure and function in contralateral human motor hand area. Neuroimage. 2011 Jan 1;54(1):32-41. doi: 10.1016/j.neuroimage.2010.08.013. Epub 2010 Aug 12.
Reference Type
BACKGROUND
Martensson J, Eriksson J, Bodammer NC, Lindgren M, Johansson M, Nyberg L, Lovden M. Growth of language-related brain areas after foreign language learning. Neuroimage. 2012 Oct 15;63(1):240-4. doi: 10.1016/j.neuroimage.2012.06.043. Epub 2012 Jun 29.
Reference Type
BACKGROUND
Kuhn S, Gleich T, Lorenz RC, Lindenberger U, Gallinat J. Playing Super Mario induces structural brain plasticity: gray matter changes resulting from training with a commercial video game. Mol Psychiatry. 2014 Feb;19(2):265-71. doi: 10.1038/mp.2013.120. Epub 2013 Oct 29.
Reference Type
BACKGROUND
Chen MH, Liao Y, Rong PF, Hu R, Lin GX, Ouyang W. Hippocampal volume reduction in elderly patients at risk for postoperative cognitive dysfunction. J Anesth. 2013 Aug;27(4):487-92. doi: 10.1007/s00540-012-1548-6. Epub 2013 Jan 31.
Reference Type
BACKGROUND
Bigler ED, Blatter DD, Anderson CV, Johnson SC, Gale SD, Hopkins RO, Burnett B. Hippocampal volume in normal aging and traumatic brain injury. AJNR Am J Neuroradiol. 1997 Jan;18(1):11-23.
Reference Type
BACKGROUND
Sagi Y, Tavor I, Hofstetter S, Tzur-Moryosef S, Blumenfeld-Katzir T, Assaf Y. Learning in the fast lane: new insights into neuroplasticity. Neuron. 2012 Mar 22;73(6):1195-203. doi: 10.1016/j.neuron.2012.01.025. Epub 2012 Mar 21.
Reference Type
BACKGROUND
Boveroux P, Vanhaudenhuyse A, Bruno MA, Noirhomme Q, Lauwick S, Luxen A, Degueldre C, Plenevaux A, Schnakers C, Phillips C, Brichant JF, Bonhomme V, Maquet P, Greicius MD, Laureys S, Boly M. Breakdown of within- and between-network resting state functional magnetic resonance imaging connectivity during propofol-induced loss of consciousness. Anesthesiology. 2010 Nov;113(5):1038-53. doi: 10.1097/ALN.0b013e3181f697f5.
Reference Type
BACKGROUND
Thirion B, Dodel S, Poline JB. Detection of signal synchronizations in resting-state fMRI datasets. Neuroimage. 2006 Jan 1;29(1):321-7. doi: 10.1016/j.neuroimage.2005.06.054. Epub 2005 Aug 29.
Reference Type
BACKGROUND
Desmond JE, Glover GH. Estimating sample size in functional MRI (fMRI) neuroimaging studies: statistical power analyses. J Neurosci Methods. 2002 Aug 30;118(2):115-28. doi: 10.1016/s0165-0270(02)00121-8.
Reference Type
BACKGROUND
Steinmetz LRaJ. Anæstesi. 4 ed. Denmark: FADL's Forlag; 2014 24. marts 2014.
Reference Type
BACKGROUND
Warner ME, Benenfeld SM, Warner MA, Schroeder DR, Maxson PM. Perianesthetic dental injuries: frequency, outcomes, and risk factors. Anesthesiology. 1999 May;90(5):1302-5. doi: 10.1097/00000542-199905000-00013.
Reference Type
BACKGROUND
Editors ICoMJ. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals [Web page, recommandation]. Online: Annals of Internal Medicine / American College of Physicians.; 1978 (updated 2017) [cited 2018 20.03.2018]. Available from: http://www.icmje.org/recommendations/.
Reference Type
BACKGROUND
Universities WgsubtMoHEaSatoD. The Danish Code of Conduct for Research Integrity [Code of conduct]. Online (www.ufm.dk): Danish Ministry of Higher Education and Science; 2014 [updated June 02, 2015; cited 2018 20.03.2018]. Available from: https://ufm.dk/en/publications/2014/the-danish-code-of-conduct-for-research-integrity.
Reference Type
BACKGROUND
Madsen SS, Moller K, Olsen KS, Vestergaard MB, Lindberg U, Larsson HBW, Martensson J, Werner MU, Santos SAG, Asghar MS. Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain - A 3-T magnetic resonance imaging study of healthy volunteers. Trials. 2020 Sep 22;21(1):805. doi: 10.1186/s13063-020-04468-y.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
http://www.nejm.org/doi/full/10.1056/NEJM184611180351601
Bigelow, Henry Jacob: Insensibility during Surgical Operations Produced by Inhalation. The Boston Medical and Surgical Journal. 1846, Volume 35, Issue 16, pp. 309-317.
https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system
American Society of Anesthesiologists Physical Status Classification System
http://www.dasaim.dk/wp-content/uploads/2019/08/Observation-efter-an%C3%A6stesi-Dec-2015.pdf
Danish Society for Anaesthesiology and Intensive Care recommendation for post-anaesthesia observation
http://www.dasaim.dk/wp-content/uploads/2019/02/udskrivningskriterier-2019.pdf
Danish Society for Anaesthesiology and Intensive Care recommendation for discharge after anaesthesia
http://pro.medicin.dk
Danish Medicines Information webpage
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-18028925
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Interaction of Sevoflurane Propofol and Remifentanil in Anesthesia for Laparoscopic Surgery
NCT02457442
COMPLETED
PHASE4
Sevoflurane General Anesthetic and Spatial Memory in Humans
NCT05991817
RECRUITING
Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium
NCT02785653
COMPLETED
PHASE4
Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI
NCT02111447
TERMINATED
PHASE4
The Effect of DSA on Recovery of Anaesthesia in Children
NCT05525104
COMPLETED
NA
Anesthetic Neurotoxicity: the Association Between General Anesthesia and the Level of Plasma Neurofilament Light
NCT04164329
UNKNOWN
Comparison of Two Anaesthetics on Brain During Brain Tumour Surgery
NCT02229201
COMPLETED
PHASE1
Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea
NCT00452855
COMPLETED
NA
A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane
NCT06773351
NOT_YET_RECRUITING
PHASE4
Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
NCT02181543
COMPLETED
PHASE3
Does Sevoflurane Cause Genomic Damage
NCT03109119
UNKNOWN
PHASE4
Interaction of Volatile Anesthetics With Magnesium
NCT05261516
RECRUITING
PHASE4
Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia
NCT01506622
COMPLETED
NA
Inhalational Anesthesia and Precipitation of Dementia: is There a Link?
NCT01903421
UNKNOWN
NA
Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry
NCT01219569
COMPLETED
General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
NCT05210764
RECRUITING
Laryngeal Injuries After Anesthesia Induction With Sevoflurane and After Anesthesia Induction With Rocuronium
NCT01591031
COMPLETED
NA
Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
NCT01662622
COMPLETED
PHASE4
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
NCT05991453
RECRUITING
NA
Comparison of Propofol, Propofol-remifentanil and Propofol-ketamine Anesthesia During Electroconvulsive Therapy
NCT02819375
COMPLETED
PHASE4
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol
NCT03841812
COMPLETED
PHASE3
Sevoflurane vs Propofol Effect on Endothelial Damage Markers After Knee Ligament Surgery.
NCT03772054
COMPLETED
NA
Premedication on Sevoflurane Induction
NCT00723164
COMPLETED
NA
The Staircase Phenomenon Implications on Neuromuscular Block Monitoring
NCT03146767
COMPLETED
NA