Neoplasms

Nervous System Diseases

All Conditions

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Patients undergoing elective supratentorial tumor surgery under general anesthesia will be ventilated with positive end-expiratory pressures of 0, 5 and 10 cmH2O after craniotomy.

Patients will be ventilated with a PEEP of 5 cmH2O during induction of anesthesia. After craniotomy, the PEEP will be reduced to 0 cmH2O for 5 minutes and data will be collected at the end of 5 minutes. Next, PEEP will be increased to 5 cmH2O for 5 minutes and data will be collected at the end of 5 minutes. Finally, PEEP will be increased to 10 cmH2O for 5 minutes and data will be collected at the end of 5 minutes.

PEEP variations

Özlem Korkmaz Dilmen, MD

Eren F Akcil, MD

Ozlem K Korkmaz Dilmen, MD

Yusuf Tunali, MD

We aim to determine the level of intraoperative PEEP that optimizes lung compliance without causing a rise in subdural pressure and if we can utilize optic nerve sheath diameter measurement as an indicator for ICP while optimizing lung compliance during supratentorial tumor surgeries.

Application of positive end-expiratory pressure (PEEP) during general anesthesia minimizes ventilation/perfusion mismatch, intraoperative atelectasis and postoperative pulmonary complications. PEEP application in intracranial surgeries is usually avoided due to the risk of raised intracranial pressure (ICP) leading to decreased cerebral perfusion pressure (CPP). Several studies examine the effects of PEEP on subdural pressure and CPP however none examine how lung compliance is affected at the same time. Ultrasound-guided measurement of optic nerve sheath diameter (ONSD) is an indirect indicator of raised ICP and there is limited literature on the correlation of ONSD and ICP during intracranial surgery. In this study, we aim to determine the level of intraoperative PEEP that optimizes lung compliance without causing a rise in subdural pressure and if we can utilize ONSD measurement as an indicator for ICP while optimizing lung compliance during supratentorial tumor surgeries.

After craniotomy, PEEP will be adjusted to 0 cmH2O, 5 cmH2O and 10 cmH2O for 5 minutes each to collect the data

Care provider will adjust the PEEP level, make measurements and record arterial blood gas analysis results. Biostatistician will compare data set at each PEEP to each other. Investigator will analyze the data

Effect of PEEP on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure

The Effect of Intraoperative Variations in Positive-End Expiratory Pressure on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure in Supratentorial Tumor Surgery

Obtained by PaO2/FiO2. Hence FiO2 will be recorded at the times of measurements

Calculated from subdural pressure and mean arterial pressure

22G/ 0.9mm catheter will be introduced into subdural space after craniotomy and connected to the transducer for pressure measurement

Ultrasound-guided measurement with the linear probe.

Invasive blood pressure monitoring will be done. The transducer will be kept at the same level as the transducer for the subdural pressure, at the level of the external ear canal

1: dura is under the cranium, 2: dura is at the level of the cranium, 3: dura is above the cranium 4: dural pulsations ceased

Arterial oxygen pressure and arterial carbon dioxide pressure will be recorded

% - measurement taken with INVOS cerebral oximeter

L/cmH2O - measurement taken from Draeger Dräger Perseus® A500 mechanical ventilator

Istanbul University

Professor in Anesthesiology and Reanimation

Platelet Aggregation Inhibitors

Propofol

Sevoflurane

Isoflurane

Desflurane

Anesthetics, General

Hypnotics and Sedatives

Anesthetics, Intravenous

Maintenance of general anesthesia with propofol infusion

Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)

Volatile Agent

This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.

General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial

General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia

Stony Brook University

Professor and Vice Chairman

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Anticonvulsants

Rocuronium

Bromides

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

1. An I-gel mask is inserted for the mechanical ventilator of the patient who is sedated with propofol.
2. For the ultrasound-guided obturator nerve (ON) block, and needle tip gradually advanced to the anterior branch of the ON. The current intensity for the stimulation of ON starts at 1.0 mA (using the sequential electrical nerve stimulation mode), and the needle is advanced gradually to the location where the contraction of the adductor longus muscle (ALM) occurs at 0.3-0.5 mA.
3. After fixing the needle in that position, measure the current intensity.
4. Then, rocuronium (0.6 mg/kg) is administered under quantitative neuromuscular-blockade monitoring.
5. When the train-of-four count becomes 0, the current intensity is increased until the contraction of the ALM occurs.
6. The current intensity is measured when the contraction of the ALM occurs.

After measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered.

Rocuronium Bromide

Measuring the minimum current intensity for the stimulation of the obturator nerve to show the contraction of the adductor longus muscle.

Nerve stimulator

Ki Tae Jung, M.D., Ph.D.

Su Yeon Cho, M.D.

The purpose of the present study was to find out the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during the obturator nerve block procedure for TURP.

During the transurethral resection of bladder tumors (TURBT) procedure under spinal anesthesia, the obturator nerve block is required to prevent the accidental movement of adductor longus muscles by electrical stimulation. However, during general anesthesia, the contraction of the adductor longus muscle would be lost due to deep neuromuscular blockade. However, some reports showed that the contraction of the adductor longus muscle occurs even in the deep neuromuscular blockade.

The current intensity for the nerve stimulation during nerve block is 0.3--0.5 mA when the needle tip is near the nerve. However, it is still unknown what current intensity is required to show the contraction of the adductor longus muscle when the patient is in a deep neuromuscular blockade.

Therefore, in this study, investigators aimed to determine the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during obturator nerve block for TURP. In addition, investigators aimed to determine that the obturator nerve block is required during the TURP procedure in patients with deep neuromuscular blockade during general anesthesia.

Patients undergoing TURP procedure under general anesthesia

Current Intensity for the Obturator Nerve Block

The Difference in the Current Intensity for the Obturator Nerve Block According to the Presence or Absence of Neuromuscular Blockage

The current intensity for the stimulation of the obturator nerve starts at 1.0 mA (using the sequential electrical nerve stimulation mode), and the needle is advanced gradually to the location where the stimulus response occurs at 0.3-0.5 mA. After fixing the needle position in a position where contraction of the adductor longus muscle responds to the minimum current intensity, measure the current intensity.

After administration of rocuronium (0.6 mg/kg), when the train-of-four count becomes 0, the current intensity for the stimulation of the obturator nerve is increased until the contraction of the adductor longus muscle occurs. The current intensity is measured when the contraction of the adductor longus muscle occurs.

After administration of rocuronium (0.6 mg/kg), the quantitative neuromuscular blockade monitoring using train-of-four is observed with 12 seconds interval. At each time point, the current intensity for the obturator nerve is increased until the contraction of the adductor longus muscle occurs. The current intensity at each time point is measured.

Chosun University Hospital

Professor

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Nausea

Vomiting

Postoperative Nausea and Vomiting

Signs and Symptoms, Digestive

Breast Diseases

Skin Diseases

Postoperative Complications

Liangcheng Zhang, Ph.D

Postoperative nausea and vomiting ( PONV ) is one of the common complications after general anesthesia while genetic factors may play an important role in Postoperative nausea and vomiting. In this study, the investigators investigated the relationship between gene polymorphism ( such as single nucleotide polymorphism ) of the gene HTR3A ( 5-hydroxytryptamine receptor 3A ), HTR3B ( 5-hydroxytryptamine receptor 3B ), HTR3C ( 5-hydroxytryptamine receptor 3C ) and TACR1 ( tachykinin receptor 1 ) etc. with nausea and vomiting after general anesthesia. Simultaneously, the investigators explored the influencing factors of nausea and vomiting.

Materials and methods:

Demographic data and risk factors responsible for PONV, including the history of PONV and motion sickness, were collected preoperatively by interviewing participants the day before anesthesia.

All study subjects received a standardized anesthesia regimen. General anesthesia was induced by midazolam 0.04 mg/kg, propofol 1.5 mg/kg, sufentanil 0.4 μg/kg, and cisatracurium 0.2 mg/kg (to facilitate tracheal intubation) given intravenously.Participants' lungs were ventilated with 50% oxygen in air.

During general anesthesia, concentration of sevoflurane maintained 1.0% to 3.0% at the discretion of anesthetist who was not involved in the study. General anesthesia also uses propofol 1 mg kg-1 h-1 and sufentanil 0.1 μg kg-1 h-1 by continuous intravenous infusion. An Entropy index monitor was used to maintain the appropriate anesthesia depth by 40-60. Participants received a repeated bolus of sufentanil 0.1 μg/kg or cisatracurium intravenously on demand.

After surgery the investigators recorded the data such as Anesthesia duration, doses of sufentanil and propofol and so on.

At the end of surgery and after returning to the ward, flurbiprofen axetil 50 mg injection i.v. was administered as an analgesic therapy, respectively. Cholinesterase inhibitor-based neuromuscular reversal drugs and vitamine B6 were not administered after surgery. Bucinnazine hydrochloride 100 mg intramuscular injection (i.m.) as a rescue medication was administered to any participant whose visual analogue scale/score (VAS) was \> 3.

Ondansetron was given intravenously to the participants if necessary or requested . Unaware of the genotypes of the subjects, the investigators collected the participants' data including nausea, vomiting and pain.

Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population

Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting Undergoing Breast Surgery With General Anesthesia in Chinese Han Population

Nausea was defined as a feeling of wanting to throw up or about to throw up.

Vomiting was defined as the discharge of the stomach contents, while retching as an involuntary attempt to vomit that did not produce stomach contents. Retching was considered as vomiting.

The level of participants' nausea was rated on four-point scales: 0=no nausea; 1=mild nausea with activities; 2=mild nausea at rest; and 3=se-vere nausea at rest.

The investigators defined an emetic episode as a single occurrence of vomiting/retching or as a series of immediately successive vomiting/retching. However, vomiting/retching had to be separated by at least 1 minute to be classified as a single emetic episode.

Fujian Medical University Union Hospital

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Vasoconstrictor Agents

Norepinephrine

The study is conducted from one hour after incision and lasts for approximately half an hour. Measurements are conducted at three levels of mean arterial pressure:

* MAP set at 80-85 mmHg for 5 min.
* MAP set at 70-75 mmHg for 5 min.
* MAP set at 60-65 mmHg for 5 min.

Blood pressure control is by infusion of noradrenaline. When the evaluations have been conducted blood pressure control is according to clinical practice. Measurements include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, frontal lobe and muscle oxygenation, depth of anesthesia, and arterial and central venous blood gas variables.

MAP is set at 80-85 mmHg for 5 min by infusion of noradrenaline.

MAP set at 80-85 mmHg for 5 min

MAP is set at 70-75 mmHg for 5 min by infusion of noradrenaline.

MAP set at 70-75 mmHg for 5 min

MAP is set at 60-65 mmHg for 5 min by infusion of noradrenaline.

MAP set at 60-65 mmHg for 5 min

Niels H Secher, MD, D.M.Sc.

General anesthesia often reduces blood pressure whereby blood flow to the brain and other vital organs may become insufficient. Thus, medicine is often administered to maintain blood pressure but it is unclear at what level blood pressure should be aimed at during anesthesia.

Thirty patients undergoing major abdominal surgery will be included. The study will start one hour after the start of surgery and lasts for approximately half an hour. The purpose of the study is to evaluate whether blood flow to the brain can be increased by maintaining blood pressure at a higher level than that used in clinical practice. In the study, MAP is adjusted to a high, moderate, and low level for a short time. The low level of blood pressure used in the study, corresponds to the level aimed at in clinical practice. The drug noradrenaline will be used to control blood pressure. Blood flow to the brain will be evaluated on the neck using ultrasound.

Background Propofol anesthesia reduces cerebral blood flow (CBF) and mean arterial pressure (MAP) but it is unclear whether the decrease in CBF is accentuated by hypotension. Cerebral autoregulation is generally considered to maintain CBF when MAP is between 60-150 mmHg. Hence, vasoactive medication is administered if MAP decreases to below approximately 60 mmHg.

It is controversial whether there is a plateau for cerebral autoregulation. Thus, middle cerebral artery blood velocity (MCA Vmean), as an index of CBF, is associated to MAP during pharmacological changes in MAP between approximately 40-125 mmHg. Similarly, CBF is affected by pharmacological changes in MAP between 40-80 mmHg during hypothermic cardiopulmonary bypass surgery in propofol anesthesia. Arterial hypertension may increase the lower limit of cerebral autoregulation which can be mitigated by antihypertensive treatment.

Cognitive dysfunction and delirium are common following major surgery, particularly in the elderly, and may be related to hypotension and cerebral hypoperfusion. Further, hypotensive anesthesia is associated with an increase in markers of neuronal damage, but studies have been too small to detect any difference in incidence of cognitive dysfunction following hypotensive as compared to normotensive anesthesia.

In young healthy adults, propofol anesthesia causes limited reduction in blood pressure and decreases CBF by approximately 50% by a reduction in neuronal activity. An increase in MAP from approximately 80 to 100 mmHg during propofol anesthesia does not affect CBF but it is unknown whether CBF can be increased by an increase in MAP from approximately 60 to 80 mmHg. Propofol appears to maintain cerebral autoregulation but it is unknown whether the lower level of cerebral autoregulation is affected. The internal carotid artery supplies most of CBF and dilates during moderate hypotension with maintained blood flow which indicates that the vessel contributes to cerebral autoregulation. Further, central blood volume and cardiac output may be important factors for maintaining CBF.

The study will include thirty patients planned for major abdominal surgery in propofol-remifentanil anesthesia combined with epidural analgesia. Internal carotid artery blood flow will be evaluated on the neck using duplex ultrasound. The study will be conducted one hour after the start of surgery and lasts for approximately half an hour. In the study, MAP is set pharmacologically at 80-85, 70-75 and 60-65 mmHg for a short time in random order. The level of 60-65 mmHg corresponds to the level at which MAP is maintained in clinical practice. Control of MAP is by intravenous infusion of noradrenaline, an α- and β-adrenergic agonist.

Objective The purpose of the study is to evaluate whether internal carotid artery blood flow is increased by maintaining MAP at a higher level than that used in clinical practice. Further, we evaluate whether a lower limit of cerebral autoregulation can be detected by comparing the slopes of linear regression of internal carotid artery blood flow and MAP at the evaluations when MAP is 60-65 and 70-75 mmHg and when MAP is 70-75 and 80-85 mmHg.

Hypotheses

* Internal carotid artery blood flow is higher when MAP is 80-85 mmHg as compared to a MAP of 60-65 mmHg.
* Internal carotid artery blood flow is higher when MAP is 70-75 mmHg as compared to a MAP of 60-65 mmHg.
* Internal carotid artery blood flow is higher when MAP is 80-85 mmHg as compared to a MAP of 70-75 mmHg.
* The slope of linear regression between changes in MAP and internal carotid artery blood flow is higher for the evaluations at a MAP of 70-75 and 60-65 mmHg than for the evaluations at a MAP of 80-85 and 70-75 mmHg.

Methods The study is a single-center, prospective cohort study of thirty consecutive patients planned for major abdominal surgery in propofol anesthesia. In case surgery is cancelled, or if gas anesthesia is used the patient will be excluded and excluded patients will be replaced. The number of drop-outs is expected to be between zero to five patients. Patients will be recruited the day before surgery, at which time the internal carotid artery will be evaluated using ultrasound. In case the vessel cannot be visualized, e.g. due to high localization of the carotid bifurcation the patient will not be able to participate in the study.

Anesthesia and surgery are according to clinical practice. Anesthesia is induced by propofol and maintained by propofol and remifentanil. A thoracic epidural catheter is placed at Th8/9 or Th9/10 and epidural anesthesia is initiated before surgery by bupivacaine infusion 0.5%, 5 ml/hr. and bolus 15 mg bupivacaine that is repeated hourly. Stroke volume is optimized after induction of anesthesia by repeated administration of 250 ml 5% human albumin until the increase in stroke volume is less than 10%, and volume optimization is repeated in case of persistent decrease in stroke volume by more than 10%. Noradrenaline infusion (0.6 µg/kg\*ml) is started after induction of anesthesia to maintain MAP above 60 mmHg and to avoid volume optimization when the circulation is dilated.

Development of a so-called mesenteric traction syndrome can affect MAP in the first hour of major abdominal surgery. Thus, the study is conducted from 60 min after incision and lasts for approximately half an hour. Anesthesia reduces MAP, but the reduction varies between patients and is affected by administration of propofol, remifentanil, and epidural anesthesia, fluid status, and surgical stimulation etc. The start of the study is postponed until any larger bleeding, transfusion or volume optimization is treated or finished. Before the start of the study, the infusion speed of propofol and remifentanil must have been constant for at least 10 min, and at least 15 min must have elapsed since the last bolus dose bupivacaine, as any changes in anesthesia may affect both cerebral and central hemodynamics. In case the infusion of propofol or remifentanil is changed or bolus bupivacaine is administered during the study, the experiment is halted, and the study is restarted when the anesthesia has been stable for 10 min. The experiment can only be restarted once and only data from the last trial with the highest number of evaluations are used.

In the experiment MAP is temporally set to 80-85, 70-75, and 60-65 mmHg by adjusting the infusion of noradrenaline. The order of evaluations is randomized by drawing an envelope just before the start of the experiment. Noradrenaline is short lasting and have no direct effect on CBF. The experiment lasts approximately 30 min until evaluations have been conducted at the three levels of MAP. If MAP does not drop to 60-65 mmHg by halting the infusion of noradrenaline this evaluation is not conducted but we expect that this will be the case in only few patients. In clinical practice noradrenaline is used to maintain MAP \> 60 mmHg. The study is not an investigation of medicinal products as noradrenaline is used as a tool to control MAP.

Administration of noradrenaline is by a central venous or large peripheral catheter, using an electronic infusion pump, and infusion speed is adjusted slowly until the level of MAP is reached. Noradrenaline is effective within 1-2 min after administration and the effect lasts only for a few minutes. When MAP has been stable at the desired level for at least 3 min, measurements are conducted during the following 2 min. When the study is finished, control of MAP will be according to clinical practice. We consider that there is no increased risk by a short term increase in MAP to 80-85 mmHg.

Measurements Arterial and central venous pressure are determined invasively while stroke volume, cardiac output, and total peripheral resistance are evaluated by modified pulse-contour analysis of the arterial pressure curve (Nexfin, BMEYE, Holland). Cerebral and biceps muscle oxygenation are evaluated using near-infrared spectroscopy (INVOS 5100C, Somanetics, Troy, MI, USA). Depth of anesthesia is assessed by Bispectral Index (BIS Complete Monitoring Systems, Covidien, USA).

Internal carotid artery blood flow is evaluated unilaterally on the neck using duplex ultrasound (Logiq E, GE Medical System, Jiangsu, Kina). Evaluation is in the longitudinal section at least 1.5 cm distal to the carotid bifurcation with the head turned approximately 30⁰ to the contralateral side. In order to limit the influence of ventilation, three recordings of approximately 15-20 s are conducted at each level of MAP and the mean is reported. A frequency of 8-12 MHz is used and gain is set as high as possible while vessel lumen is echo-free. Ultrasonic adjustments are not changed during the study. Diameter is assessed using automatic software to track the vessel wall (Brachial Analyser for Research v. 6, Medical Imaging Applications LLC, Coralville, IA, USA). The angle-corrected time maximum flow velocity (TAVMAX) is evaluated using pulsed-wave Doppler at an angle of insonation ≤ 60º. The TAVMAX corresponds to twice the mean blood velocity and blood flow is: 0.125\*60\*TAVMAX\*π\*diameter\^2. Arterial and central venous blood is sampled for gas analysis and internal carotid artery blood flow is corrected for changes in PaCO2 using a factor of 3%/mmHg.

Statistics Trial size: The minimal clinically important difference in internal carotid artery blood flow between evaluations at MAP 60-65 and 80-85 mmHg is considered to be 10% as evaluations using near-infrared spectroscopy indicate that intraoperative cerebral deoxygenation of \> 10% associates to postoperative cognitive function.

A power calculation indicated that at least 18 patients were required to detect a difference in internal carotid artery blood flow of 10% corresponding to 19 ml/min assuming a standard deviation for the change of 27 ml/min (unpublished results from the study "Cerebral Blood Flow During Propofol Anaesthesia" NCT02951273) to obtain a 5% significance level and a power of 80%. We plan to include 30 patients.

The Effect of Blood Pressure on Cerebral Blood Flow During Propofol Anesthesia

Internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound when MAP is set to 80-85 and 60-65 mmHg for 5 min as part of the experiment during propofol anesthesia

Internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound when MAP is set to 70-75 and 60-65 mmHg for 5 min as part of the experiment during propofol anesthesia

Internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound when MAP is set to 80-85 and 70-75 mmHg for 5 min as part of the experiment during propofol anesthesia

Internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound and MAP \[mmHg\] determined by radial artery cannulation when MAP is set to 80-85, 70-75, and to 60-65 mmHg for 5 min as part of the experiment during propofol anesthesia. The slope of linear regression of MAP and internal carotid artery blood flow is determined for the evaluations when MAP is set to 80-85 and 70-75 mmHg and for the evaluations when MAP is set to 70-75 and 60-65 mmHg, respectively, and the slopes are compared

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of PEEP on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure	NCT04316208	Supratentorial ... Anesthesia, Gen... Optic Nerve	PEEP variations	18 Years - 70 Years	Istanbul University
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial	NCT03034096	Anesthesia, Gen... Surgical Oncolo...	Propofol Volatile Agent	18 Years -	Stony Brook University
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial	NCT03034096	Anesthesia, Gen... Surgical Oncolo...	Propofol Volatile Agent	18 Years -	Stony Brook University
Current Intensity for the Obturator Nerve Block	NCT05872451	Bladder Tumor	Rocuronium Brom... Nerve stimulato...	18 Years -	Chosun University Hospital
Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population	NCT03705026	Breast Neoplasm... Anesthesia, Gen...		18 Years - 80 Years	Fujian Medical University Union Hospital
The Effect of Blood Pressure on Cerebral Blood Flow During Propofol Anesthesia	NCT03309917	Gastrointestina... Anesthesia, Gen...	MAP set at 80-8... MAP set at 70-7... MAP set at 60-6...	19 Years -	Rigshospitalet, Denmark

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