Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Musculoskeletal Diseases

Rare Diseases

Pain, Postoperative

Pain

Spinal Cord Neoplasms

Spinal Neoplasms

Postoperative Complications

Neurologic Manifestations

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Bone Neoplasms

Bone Diseases

Spinal Diseases

Acute Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Psychotropic Drugs

Analgesics

Channel Blockers

Anticonvulsants

Bone Density Conservation Agents

Anesthetics

Esketamine

Ketamine

Pregabalin

Anesthetics, Dissociative

Anesthetics, Intravenous

Anesthetics, General

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Anti-Anxiety Agents

Antidepressive Agents

* Drug: Pregabalin
* 150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7 days(POD1-7), followed by dose reduction to 75mg once daily for 7 days(POD8-14)
* Drug: S-ketamine infusion
* 0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous infusion for 48 h

S-ketamine and pregabalin

* Drug: Placebo capsules
* Two placebo capsules (2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days
* Drug: Normal saline
* 0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours

Normal saline and placebo capsule

Ruquan Han, M.D., Ph D.

Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.

Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.

The primary outcome was the proportion of patients with acute moderate-to-severe postsurgical pain during the 48-h postoperative period (defined as a VAS score ≥ 40 mm).

Beijing Tiantan Hospital

Professor

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Aim of gross total resection (i.e. removal of contrast enhancing tumor) according to institutional practice. No limit in use of technical adjuncts in this arm.

Aim of supramarginal resection, where a margin of at least 10 mm is considered feasible prior to surgery. The resection is guided by the T2 volume (i.e. zone of edema) where removal of as much as possible of this zone (or beyond) is attempted as long as considered safe

Supramarginal resection

Conventional surgery

Asgeir S Jakola, MD, PhD

Sasha Gulati, MD, PhD

Georg Widhalm

Frants R Poulsen

Christian Bonde Pedersen

Jarno Satopää

Justiina Huhtakangas

Olli-Pekka Kämäräinen

Sami Tetri

Joonas Haapasalo

Ville Vuorinen

Jussi Posti

Ruby Mahesperan

Einar Vik-Mo

Eirik Helseth

Roar Kloster

Ole Solheim

Sasha Gulati

Asgeir S Jakola

Louise Carstam

Peter Milos

Gregor Tomasevic

Margret Jensdottir

Jiri Bartek jr

Rickard Sjöberg

Mats Ryttlefors

Geir Bråthen, MD, PhD

Gliomas are the most common malignant brain tumor. Glioblastoma, WHO grade IV astrocytoma, is the most common subtype and unfortunately also the most aggressive subtype with median survival in population based cohorts being only 10 months. Extensive surgical resections followed by postoperative fractioned radiotherapy and concomitant and adjuvant temozolomide prolong survival and is the standard treatment.

The investigators think there is significant potential in individualized surgical decision-making in glioblastoma management. The idea that some patients are amendable to radical surgery, while others should be treated more conservatively, is not controversial in other fields of oncology. The current concept in all patients with glioblastoma is "maximum safe resection of the contrast enhancing tumor", but this may in selected cases be extended to simply "maximum safe resection" tailored to the patient and extent of disease at hand.

Densely proliferating tumor cells have been found from at an average of 10 mm beyond the margins of contrast enhancement in high-grade gliomas. There are now several case series, using various definitions of supramarginal resection, but they have in common that they report a benefit of resection with a margin. This potential benefit also comes together with an associated neurological risk, making this approach unethical and simply not feasible in the patients with glioblastoma as a whole.

Objective of this study is: To investigate if resection with a margin, that is significantly beyond the radiological contrast enhancement, improves survival in selected patients with glioblastoma.

Participants will be masked until postoperative period. Outcome assessor will be masked until all predefined outcomes have been analysed

Supramarginal Resection in Glioblastoma

Supramarginal Resection in Patients With Glioblastoma: A Randomised Controlled Trial

Accounting for cross-over or failure to achieve predefined surgical aim. "As treated" populations when no margins in supramarginal group and unintended contrast remnant in group aiming at conventional gross-total resection or even if significant supramarginal resection in this group

Overall survival according to intention-to-treat

Neurological assessment in Neuro-Oncology (NANO) Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a tumor within the central nervous system. The NANO is composed of 9 items. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NANO scale score. The maximum possible score is 23, with the minimum score being a 0.

The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The QLQ-C30 is a cancer health-related quality-of-life questionnaire that has been widely used in clinical trials and investigations using PROs for individual patient management. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Most items use a "past week" recall period. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.

The European Organization for Research and Treatment of Cancer (EORTC) QLQ-BN20 is a quality of life assessment specific to brain neoplasms. Consists of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit. Items are presented as questions on a scale ranging from 1 = "not at all" to 4 = "very much." Higher score means worse outcome.

The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.

surgical complication grade 3, 4 and 5, assessed using the Dindo-Clavien classification

Resection proportion with contrast remnant

Proportion with remnant in terms of hyper intensity changes in T2/FLAIR

Cavity volume/contrast enhancement volume

Odense University Hospital

Sahlgrenska University Hospital, Sweden

Turku University Hospital

Karolinska University Hospital

Norwegian University of Science and Technology

University Hospital, Linkoeping

Uppsala University Hospital

University Hospital, Umeå

Skane University Hospital

Haukeland University Hospital

Ullevaal University Hospital

Rikshospitalet University Hospital

University Hospital of North Norway

Tampere University Hospital

Helsinki University Central Hospital

Kuopio University Hospital

Oulu University Hospital

Medical University of Vienna

Paracelsus Medical University

St. Olavs Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Wounds and Injuries

Lung Injury

Ventilator-Induced Lung Injury

Lung Diseases

Respiratory Tract Diseases

Thoracic Injuries

Micronutrients

Vitamins

Ascorbic Acid

Trace Elements

Antioxidants

Protective Agents

Vitamin C

Patients received 50 mg/kg of Ascorbic acid after induction of anesthesia

Patients receive 50ml saline after induction of anesthesia

After participants underwent induction of anesthesia, Ascorbic acid (Vitamin C Injection) was administered at a dosage of 50 mg/kg, diluted to 50 ml using saline, with a total amount not exceeding 4 g; pumping was performed using a micro pump at a rate of 25 ml/h.

Ascorbic acid

After participants underwent induction of anesthesia, 50 ml of saline was used and pumped using a micro pump at a rate of 25 ml/h.

Saline

Dong Wang, M.D

Linquan Shao

Dong Wang, Doctor of Medicine(M.D.)

The goal of this clinical trial is to investigate the effect of perioperative administration of vitamin C on postoperative pulmonary complications, with the aim of providing a safe and effective medication regimen for the prevention and treatment of postoperative pulmonary complications in patients undergoing surgery for craniocerebral tumors. The main questions it aims to answer are:

1. To determine whether vitamin C can reduce pulmonary complications after surgery for intracranial tumors.
2. Does intraoperative vitamin C improve the prognosis of surgical patients

Researchers will compare vitamin C to a placebo (saline) to see if vitamin C is effective for postoperative lung complications in patients undergoing surgery for cranial tumors.

1. Participants will be intravenously pumped with vitamin C for two hours after induction of anesthesia.
2. Participants will have intraoperative plasma sampling and recording of ventilator parameters, monitor parameters and perioperative data.
3. Participants will be followed up until discharge from the hospital to record symptoms and adverse events, and will be called at six months to check on their prognosis.

Neurosurgery has a high incidence of postoperative pulmonary complications, increasing patient costs and affecting patient prognosis. Neurosurgery often requires hyperventilation to reduce intracranial pressure, so methods to reduce postoperative pulmonary complications such as small tidal volumes cannot be used routinely, and larger tidal volumes often result in injury to pulmonary endothelial cells, which leads to increased permeability of the pulmonary microvasculature, resulting in mechanically ventilated lung injury. Of course surgical injuries and mechanical ventilation can also cause oxidative stress injury to the lungs. Vitamin C is a common antioxidant drug and cofactor in the synthesis of many substances in the body, and many studies have shown that vitamin C prevents the increase in endothelial barrier permeability due to many causes. During the COVID-19 epidemic, vitamin C is seen as an important adjunct in preventing and ameliorating symptoms of COVID-19 patients. not only that, but vitamin C also assisted in postoperative analgesia and promote incision healing, so investigators would like to observe that by giving vitamin C during the surgery is able to prevent the occurrence of postoperative pulmonary complications or improve the prognosis of participants.

Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery

Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial: a Randomized, Double-blind, Placebo-controlled Study

Individual Participant Data(IPD) will be available when this trial is finished and the article have been published

This will be assessed using the Postoperative Pulmonary Complications Score, which ranges from 0 to 5, with a score of ≥3 being considered positive for postoperative pulmonary complications. It was assessed every day before discharge and the highest score that occurred was recorded.

Plasma levels of neuron-specific enolase, unit is ng/ml

Length of time between participant's completion of surgery and discharge

Patient's postoperative pain level; Using a "Pain Visual Analogue Scale", a 10-centimeter-long ruler was used, with 0 indicating no pain and 10 representing the most intense pain that was intolerable. During the test, the participant points to the scale that best represents the level of pain, and the researcher assigns the participant a score based on the location of the point.

lung compliance in Milliliter/ centimeter water column

The level of Interleukin-6 in the blood, in nanograms per liter

Blood levels of superoxide dismutase, in units per milliliter

Postoperative body temperature in degrees Celsius

Systolic and diastolic blood pressure，In millimeters of mercury

Plasma levels of brain-specific cardiolipin

Levels of neutrophils in the blood, measured in units per liter.

Level of C-reactive protein in the blood in milligrams per liter

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.	NCT05096468	Esketamine Pregabalin Acute Postopera... Neurosurgical P... Perioperative C... Spinal Cord Neo...	S-ketamine and ... Normal saline a...	18 Years - 65 Years	Beijing Tiantan Hospital
Supramarginal Resection in Glioblastoma	NCT04243005	Glioblastoma	Supramarginal r... Conventional su...	18 Years -	St. Olavs Hospital
Supramarginal Resection in Glioblastoma	NCT04243005	Glioblastoma	Supramarginal r... Conventional su...	18 Years -	St. Olavs Hospital
Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery	NCT06421688	Ascorbic Acid Neurosurgical P... Humans Ventilator-Indu... Postoperative C...	Ascorbic acid Saline	18 Years - 75 Years	Qianfoshan Hospital

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