Effect of perioperative dexmedetomidine on postoperative delirium in patients with brain tumours: a protocol of a randomised controlled trial
IntroductionNeurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients unde...
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| Published in | BMJ open Vol. 14; no. 11; p. e084380 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
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England
British Medical Journal Publishing Group
07.11.2024
BMJ Publishing Group LTD BMJ Publishing Group |
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| Abstract | IntroductionNeurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients undergoing neurosurgical resections of temporal glioma.MethodsThis is a single-centre, randomised, blinded and parallel-group controlled trial. A total of 366 patients will be randomised to either dexmedetomidine group (n=183) or placebo group (n=183). Subjects assigned to dexmedetomidine group will be given a continuous infusion at 0.4 µg/kg/h after anaesthesia induction until dural closure and then immediately receive an infusion of dexmedetomidine at 0.08 µg/kg/h by intravenous analgesia pump during the first 48 hours postoperatively. Patients in the placebo group will be given comparable volumes of normal saline, and intravenous analgesia pumps contain equal amounts of sufentanil and antiemetics, but no dexmedetomidine. The primary outcome is the incidence of postoperative delirium, which will be assessed with the Confusion Assessment Method two times per day during the first five postoperative days.Ethics and disseminationThe protocol (V.1.1) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-186-02). The findings of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.Trial registration number NCT06164314. |
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| AbstractList | Neurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients undergoing neurosurgical resections of temporal glioma.
This is a single-centre, randomised, blinded and parallel-group controlled trial. A total of 366 patients will be randomised to either dexmedetomidine group (n=183) or placebo group (n=183). Subjects assigned to dexmedetomidine group will be given a continuous infusion at 0.4 µg/kg/h after anaesthesia induction until dural closure and then immediately receive an infusion of dexmedetomidine at 0.08 µg/kg/h by intravenous analgesia pump during the first 48 hours postoperatively. Patients in the placebo group will be given comparable volumes of normal saline, and intravenous analgesia pumps contain equal amounts of sufentanil and antiemetics, but no dexmedetomidine. The primary outcome is the incidence of postoperative delirium, which will be assessed with the Confusion Assessment Method two times per day during the first five postoperative days.
The protocol (V.1.1) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-186-02). The findings of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.
NCT06164314. IntroductionNeurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients undergoing neurosurgical resections of temporal glioma.MethodsThis is a single-centre, randomised, blinded and parallel-group controlled trial. A total of 366 patients will be randomised to either dexmedetomidine group (n=183) or placebo group (n=183). Subjects assigned to dexmedetomidine group will be given a continuous infusion at 0.4 µg/kg/h after anaesthesia induction until dural closure and then immediately receive an infusion of dexmedetomidine at 0.08 µg/kg/h by intravenous analgesia pump during the first 48 hours postoperatively. Patients in the placebo group will be given comparable volumes of normal saline, and intravenous analgesia pumps contain equal amounts of sufentanil and antiemetics, but no dexmedetomidine. The primary outcome is the incidence of postoperative delirium, which will be assessed with the Confusion Assessment Method two times per day during the first five postoperative days.Ethics and disseminationThe protocol (V.1.1) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-186-02). The findings of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.Trial registration number NCT06164314. IntroductionNeurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients undergoing neurosurgical resections of temporal glioma.MethodsThis is a single-centre, randomised, blinded and parallel-group controlled trial. A total of 366 patients will be randomised to either dexmedetomidine group (n=183) or placebo group (n=183). Subjects assigned to dexmedetomidine group will be given a continuous infusion at 0.4 µg/kg/h after anaesthesia induction until dural closure and then immediately receive an infusion of dexmedetomidine at 0.08 µg/kg/h by intravenous analgesia pump during the first 48 hours postoperatively. Patients in the placebo group will be given comparable volumes of normal saline, and intravenous analgesia pumps contain equal amounts of sufentanil and antiemetics, but no dexmedetomidine. The primary outcome is the incidence of postoperative delirium, which will be assessed with the Confusion Assessment Method two times per day during the first five postoperative days.Ethics and disseminationThe protocol (V.1.1) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-186-02). The findings of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.Trial registration numberNCT06164314. Neurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients undergoing neurosurgical resections of temporal glioma.INTRODUCTIONNeurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients undergoing neurosurgical resections of temporal glioma.This is a single-centre, randomised, blinded and parallel-group controlled trial. A total of 366 patients will be randomised to either dexmedetomidine group (n=183) or placebo group (n=183). Subjects assigned to dexmedetomidine group will be given a continuous infusion at 0.4 µg/kg/h after anaesthesia induction until dural closure and then immediately receive an infusion of dexmedetomidine at 0.08 µg/kg/h by intravenous analgesia pump during the first 48 hours postoperatively. Patients in the placebo group will be given comparable volumes of normal saline, and intravenous analgesia pumps contain equal amounts of sufentanil and antiemetics, but no dexmedetomidine. The primary outcome is the incidence of postoperative delirium, which will be assessed with the Confusion Assessment Method two times per day during the first five postoperative days.METHODSThis is a single-centre, randomised, blinded and parallel-group controlled trial. A total of 366 patients will be randomised to either dexmedetomidine group (n=183) or placebo group (n=183). Subjects assigned to dexmedetomidine group will be given a continuous infusion at 0.4 µg/kg/h after anaesthesia induction until dural closure and then immediately receive an infusion of dexmedetomidine at 0.08 µg/kg/h by intravenous analgesia pump during the first 48 hours postoperatively. Patients in the placebo group will be given comparable volumes of normal saline, and intravenous analgesia pumps contain equal amounts of sufentanil and antiemetics, but no dexmedetomidine. The primary outcome is the incidence of postoperative delirium, which will be assessed with the Confusion Assessment Method two times per day during the first five postoperative days.The protocol (V.1.1) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-186-02). The findings of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.ETHICS AND DISSEMINATIONThe protocol (V.1.1) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-186-02). The findings of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.NCT06164314.TRIAL REGISTRATION NUMBERNCT06164314. Introduction Neurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary hypothesis that perioperative administration of dexmedetomidine reduces the incidence of postoperative delirium in patients undergoing neurosurgical resections of temporal glioma.Methods This is a single-centre, randomised, blinded and parallel-group controlled trial. A total of 366 patients will be randomised to either dexmedetomidine group (n=183) or placebo group (n=183). Subjects assigned to dexmedetomidine group will be given a continuous infusion at 0.4 µg/kg/h after anaesthesia induction until dural closure and then immediately receive an infusion of dexmedetomidine at 0.08 µg/kg/h by intravenous analgesia pump during the first 48 hours postoperatively. Patients in the placebo group will be given comparable volumes of normal saline, and intravenous analgesia pumps contain equal amounts of sufentanil and antiemetics, but no dexmedetomidine. The primary outcome is the incidence of postoperative delirium, which will be assessed with the Confusion Assessment Method two times per day during the first five postoperative days.Ethics and dissemination The protocol (V.1.1) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-186-02). The findings of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.Trial registration number NCT06164314. |
| Author | Peng, Yuming Zeng, Min Zheng, Maoyao Li, Shu Ji, Nan Wang, Jie |
| Author_xml | – sequence: 1 givenname: Min surname: Zeng fullname: Zeng, Min organization: Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, P.R. China – sequence: 2 givenname: Maoyao surname: Zheng fullname: Zheng, Maoyao organization: Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, P.R. China – sequence: 3 givenname: Jie surname: Wang fullname: Wang, Jie organization: Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, P.R. China – sequence: 4 givenname: Shu orcidid: 0000-0002-5625-067X surname: Li fullname: Li, Shu organization: Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, P.R. China – sequence: 5 givenname: Nan surname: Ji fullname: Ji, Nan organization: Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, P.R. China – sequence: 6 givenname: Yuming orcidid: 0000-0002-2630-2467 surname: Peng fullname: Peng, Yuming email: florapym766@163.com organization: Department of Outcome Research, Cleveland Clinic, Cleveland, Ohio, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/39515867$$D View this record in MEDLINE/PubMed |
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| Keywords | Neurological oncology Neurosurgery Postoperative delirium Anaesthesia in neurology |
| Language | English |
| License | This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
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| Notes | Protocol ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 ObjectType-Undefined-1 content type line 23 MZ and MZ are joint first authors. None declared. |
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start-page: 323 year: 2019 ident: 2024121219351439000_14.11.e084380.35 article-title: Dexmedetomidine: present and future directions publication-title: Korean J Anesthesiol doi: 10.4097/kja.19259 |
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| Snippet | IntroductionNeurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test... Neurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to test the primary... Introduction Neurosurgery is a risk factor for postoperative delirium. Dexmedetomidine has a potential effect on reducing postoperative delirium. We aim to... |
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| SubjectTerms | Adult Anaesthesia Anaesthesia in neurology Analgesics Analgesics, Non-Narcotic - administration & dosage Analgesics, Non-Narcotic - therapeutic use Anesthesia Brain cancer Brain Neoplasms - surgery Brain research Cognitive ability Delirium Delirium - prevention & control Dexmedetomidine - administration & dosage Dexmedetomidine - therapeutic use Emergence Delirium - epidemiology Emergence Delirium - prevention & control Female Glioma Heart rate Humans Hypnotics and Sedatives - administration & dosage Hypnotics and Sedatives - therapeutic use Intubation Male Middle Aged Neurological oncology Neurosurgery Neurosurgical Procedures - adverse effects Patients Perioperative Care - methods Postoperative Complications - prevention & control Postoperative delirium Protocol Randomized Controlled Trials as Topic Surgery Tumors |
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| Title | Effect of perioperative dexmedetomidine on postoperative delirium in patients with brain tumours: a protocol of a randomised controlled trial |
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