Cerebral Blood Flow During Propofol Anaesthesia

NCT02951273 | Completed Results DMC

• 1 other identifier: H-16036250
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

General anaesthesia often reduces blood pressure whereby blood flow to the brain and other vital organs may become insufficient. Thus, medicine is often administered during anaesthesia to maintain blood pressure. However, it is unclear at what level blood pressure should be aimed at during anaesthesia. Several factors may affect blood flow to the brain during anaesthesia. During surgery on the internal organs, a hormone may be released that dilates blood vessels and causes a so-called mesenteric traction syndrome characterised by a decrease in blood pressure and flushing. This reaction lasts for approximately thirty minutes and is observed in about half of the patients who undergo surgery on the stomach and intestines. It is unknown whether a mesenteric traction syndrome affects blood flow to the brain. Ventilation is also of importance for blood flow to the brain. Thus, blood flow to the brain is reduced by hyperventilation and increases if breathing is slower. It is unclear whether the relation between blood flow to the brain and ventilation is affected during anaesthesia. This study will evaluate how blood flow to the brain is affected by anaesthesia and standard treatment of a possible reduction in blood pressure. Further, the study will assess whether blood flow to the brain is affected by development of a mesenteric traction syndrome. Lastly, the project will evaluate blood flow to the brain during short-term changes in the patient's ventilation by adjustments on the ventilator. Thirty patients planned for major abdominal surgery will be included in the project. The study will take place from the patient's arrival at the operation room and until two hours after the start of surgery. Placement of catheters and anaesthesia are according to standard care. Blood flow to the brain will be evaluated using ultrasound. Oxygenation of the brain, skin and muscle will be evaluated by probes that emit light. Depth of anaesthesia is assessed by recording the electrical activity of the brain. Blood pressure is measured by a catheter placed in an artery at the wrist and blood samples will be drawn from the catheter.

Conditions

Gastrointestinal Neoplasms

Keywords

abdominal surgery; blood pressure; cardiac output; cerebral blood flow; cerebral oxygenation; CO2 reactivity; duplex ultrasound; general anaesthesia; mesenteric traction syndrome; near-infrared spectroscopy; upper gastrointestinal cancer surgery

Outcome Measures

Primary Outcomes (1)

• Changes in Internal Carotid Artery Blood Flow by Treatment of Anaesthesia-induced Hypotension

  Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound.

  Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.

Secondary Outcomes (11)

• Changes in Internal Carotid Artery Blood Flow by Induction of Anaesthesia.

  Two measurements; one measurement 5-10 min before induction of anaesthesia and one measurement 5-20 min after induction of anaesthesia.

• Association by Multiple Regression Between Changes in Internal Carotid Artery Blood Flow, Mean Arterial Pressure and Cardiac Output by Treatment of Anaesthesia-induced Hypotension.

  Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.

• Changes in Frontal Lobe Oxygenation by Development of Mesenteric Traction Syndrome (MTS).

  Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.

• Changes in Forehead Skin Blood Flow by Development of Mesenteric Traction Syndrome (MTS).

  Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.

• Changes in Forehead Skin Oxygenation by Development of Mesenteric Traction Syndrome (MTS).

  Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.

Study Arms (1)

Study of cerebral blood flow

Patients undergoing oesophageal- or ventricular resection (n=30)

Other: Study of cerebral blood flow

Interventions

Study of cerebral blood flow OTHER

Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia. Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.

Study of cerebral blood flow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Thirty patients planned for oesophageal- or ventricular resection at Department of Anaesthesia, Rigshospitalet, Copenhagen, Denmark

You may qualify if:

• Patients planned for major abdominal surgery that require placement of an arterial line and central venous catheter, including oesophageal- or ventricular resection
• Age ≥ 18 years.

You may not qualify if:

• No informed consent
• Robotic assisted procedures
• Treatment with anti-inflammatory medication, including NSAID and corticosteroids
• Atherosclerosis of the internal carotid artery that obstructs ≥ 30% of the vessel lumen
• Neurologic disease considered to affect cerebral blood flow, including dementia, epilepsy, and apoplexy

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Anaesthesia, Rigshospitalet 2043

Copenhagen, 2300, Denmark

Location

Related Publications (13)

• Fujimoto Y, Nomura Y, Hirakawa K, Hotta A, Nakamoto A, Yoshikawa N, Ohira N, Tatekawa S. Flurbiprofen axetil provides a prophylactic benefit against mesenteric traction syndrome associated with remifentanil infusion during laparotomy. J Anesth. 2012 Aug;26(4):490-5. doi: 10.1007/s00540-012-1368-8. Epub 2012 Mar 2.

  PMID: 22382665 BACKGROUND

• Jorgensen LG, Perko M, Perko G, Secher NH. Middle cerebral artery velocity during head-up tilt induced hypovolaemic shock in humans. Clin Physiol. 1993 Jul;13(4):323-36. doi: 10.1111/j.1475-097x.1993.tb00333.x.

  PMID: 8370233 BACKGROUND

• Kaisti KK, Metsahonkala L, Teras M, Oikonen V, Aalto S, Jaaskelainen S, Hinkka S, Scheinin H. Effects of surgical levels of propofol and sevoflurane anesthesia on cerebral blood flow in healthy subjects studied with positron emission tomography. Anesthesiology. 2002 Jun;96(6):1358-70. doi: 10.1097/00000542-200206000-00015.

  PMID: 12170048 BACKGROUND

• Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, Hert SD, Ford I, Gonzalez-Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luscher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Sousa-Uva M, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur Heart J. 2014 Sep 14;35(35):2383-431. doi: 10.1093/eurheartj/ehu282. Epub 2014 Aug 1. No abstract available.

  PMID: 25086026 BACKGROUND

• LASSEN NA. Cerebral blood flow and oxygen consumption in man. Physiol Rev. 1959 Apr;39(2):183-238. doi: 10.1152/physrev.1959.39.2.183. No abstract available.

  PMID: 13645234 BACKGROUND

• Matta BF, Lam AM, Strebel S, Mayberg TS. Cerebral pressure autoregulation and carbon dioxide reactivity during propofol-induced EEG suppression. Br J Anaesth. 1995 Feb;74(2):159-63. doi: 10.1093/bja/74.2.159.

  PMID: 7696064 BACKGROUND

• Meng L, Hou W, Chui J, Han R, Gelb AW. Cardiac Output and Cerebral Blood Flow: The Integrated Regulation of Brain Perfusion in Adult Humans. Anesthesiology. 2015 Nov;123(5):1198-208. doi: 10.1097/ALN.0000000000000872.

  PMID: 26402848 BACKGROUND

• Nissen P, van Lieshout JJ, Nielsen HB, Secher NH. Frontal lobe oxygenation is maintained during hypotension following propofol-fentanyl anesthesia. AANA J. 2009 Aug;77(4):271-6.

  PMID: 19731845 BACKGROUND

• Ogoh S, Sato K, Okazaki K, Miyamoto T, Secher F, Sorensen H, Rasmussen P, Secher NH. A decrease in spatially resolved near-infrared spectroscopy-determined frontal lobe tissue oxygenation by phenylephrine reflects reduced skin blood flow. Anesth Analg. 2014 Apr;118(4):823-9. doi: 10.1213/ANE.0000000000000145.

  PMID: 24651237 BACKGROUND

• Takada M, Taruishi C, Sudani T, Suzuki A, Iida H. Intravenous flurbiprofen axetil can stabilize the hemodynamic instability due to mesenteric traction syndrome--evaluation with continuous measurement of the systemic vascular resistance index using a FloTrac(R) sensor. J Cardiothorac Vasc Anesth. 2013 Aug;27(4):696-702. doi: 10.1053/j.jvca.2012.11.019. Epub 2013 May 3.

  PMID: 23648081 BACKGROUND

• Torella F, McCollum CN. Regional haemoglobin oxygen saturation during surgical haemorrhage. Minerva Med. 2004 Oct;95(5):461-7.

  PMID: 15467521 BACKGROUND

• Uski T, Andersson KE, Brandt L, Edvinsson L, Ljunggren B. Responses of isolated feline and human cerebral arteries to prostacyclin and some of its metabolites. J Cereb Blood Flow Metab. 1983 Jun;3(2):238-45. doi: 10.1038/jcbfm.1983.32.

  PMID: 6341384 BACKGROUND

• Wienecke T, Olesen J, Oturai PS, Ashina M. Prostacyclin (epoprostenol) induces headache in healthy subjects. Pain. 2008 Sep 30;139(1):106-116. doi: 10.1016/j.pain.2008.03.018. Epub 2008 May 2.

  PMID: 18450380 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Niels D. Olesen
• Organization: Rigshospitalet

niels.damkjaer.olesen.01@regionh.dk

004520262459

Study Officials

• Niels H. Secher, MD, D.M.Sc.

  Department of Anaesthesia, Rigshospitalet 2043, DK-2100 Copenhagen Ø, Denmark

  STUDY DIRECTOR

• Niels D. Olesen, MD

  Department of Anaesthesia, Rigshospitalet 2043, DK-2100 Copenhagen Ø, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 1, 2016
• Study Start: December 8, 2016
• Primary Completion: July 6, 2017
• Study Completion: July 6, 2017
• Last Updated: January 17, 2018
• Results First Posted: November 17, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)