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Effect of low-dose remifentanil infusion on emergence agitation after general anaesthesia in patients undergoing intracranial surgery: study protocol of a randomised controlled trial.

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Title: Effect of low-dose remifentanil infusion on emergence agitation after general anaesthesia in patients undergoing intracranial surgery: study protocol of a randomised controlled trial.
Authors: Sun XZ; Department of Anaesthesia, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China., Zha LQ; Department of Anaesthesia, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China., Shou CJ; Department of Anaesthesia, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China., Chen MT; Department of Neurosurgery, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China., Yao YX; Department of Anaesthesia, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China yaoyongxing@zju.edu.cn.; Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.
Source: BMJ open [BMJ Open] 2025 Dec 04; Vol. 15 (12), pp. e104020. Date of Electronic Publication: 2025 Dec 04.
Publication Type: Journal Article; Clinical Trial Protocol
Language: English
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Imprint Name(s): Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
MeSH Terms: Remifentanil*/administration & dosage , Remifentanil*/therapeutic use , Anesthesia, General*/adverse effects , Craniotomy*/adverse effects , Emergence Delirium*/prevention & control , Psychomotor Agitation*/prevention & control , Analgesics, Opioid*/administration & dosage , Anesthetics, Intravenous*/administration & dosage, Humans ; Double-Blind Method ; Prospective Studies ; Randomized Controlled Trials as Topic ; Anesthesia Recovery Period ; Adult ; Infusions, Intravenous ; Female ; Male ; Middle Aged
Abstract: Introduction: Emergence agitation (EA), defined as acute postoperative restlessness after general anaesthesia, is a common complication in the post-anaesthesia care unit (PACU). The reported incidence of EA is nearly 30% in neurosurgical surgery, which bears tremendous risks for neurosurgical patients. Although current evidence suggests that remifentanil may reduce EA risk in non-cardiac settings, its preventive efficacy in patients undergoing intracranial surgery remains unclear.
Methods and Analysis: In this single-centre, randomised, double-blind, parallel-group prospective clinical trial, patients scheduled for elective craniotomy will be screened to confirm their eligibility. After surgery under general anaesthesia, patients will be assigned to groups to receive either remifentanil or placebo infusion on admission to the PACU. The remifentanil group will be given remifentanil infusion at a dose of 0.1 µg/(kg×min), whereas the control group will be given the same volume of normal saline. The primary outcome is the effect of remifentanil on EA incidence during the emergence period. Secondary outcomes include the following: time to regain consciousness, extubation time, total PACU duration, extubation comfort score measured by the modified Minogue Scale, postoperative pain intensity assessed using a Numerical Rating Scale, awakening quality and postoperative delirium assessed by alertness and orientation score, and a 3-Minute Diagnostic Interview for Confusion Assessment Method.
Ethics and Dissemination: The study protocol (V.4.0, dated 14 August 2025, No. 2025-0954) has been approved by the Institutional Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine and complies with the Declaration of Helsinki and relevant regulations for research involving human participants. Findings will be disseminated through peer-reviewed publications and conference presentations.
Trial Registration Number: ChiCTR2500096691.
(© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)
Contributed Indexing: Keywords: Anaesthesia in neurology; Emergence Delirium; Neurosurgery
Substance Nomenclature: P10582JYYK (Remifentanil)
0 (Analgesics, Opioid)
0 (Anesthetics, Intravenous)
Entry Date(s): Date Created: 20251204 Date Completed: 20251204 Latest Revision: 20251204
Update Code: 20251205
DOI: 10.1136/bmjopen-2025-104020
PMID: 41344718
Database: MEDLINE
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  Data: Effect of low-dose remifentanil infusion on emergence agitation after general anaesthesia in patients undergoing intracranial surgery: study protocol of a randomised controlled trial.
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  Data: <searchLink fieldCode="AU" term="%22Sun+XZ%22">Sun XZ</searchLink>; Department of Anaesthesia, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Zha+LQ%22">Zha LQ</searchLink>; Department of Anaesthesia, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Shou+CJ%22">Shou CJ</searchLink>; Department of Anaesthesia, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Chen+MT%22">Chen MT</searchLink>; Department of Neurosurgery, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.<br /><searchLink fieldCode="AU" term="%22Yao+YX%22">Yao YX</searchLink>; Department of Anaesthesia, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China yaoyongxing@zju.edu.cn.; Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.
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  Data: Introduction: Emergence agitation (EA), defined as acute postoperative restlessness after general anaesthesia, is a common complication in the post-anaesthesia care unit (PACU). The reported incidence of EA is nearly 30% in neurosurgical surgery, which bears tremendous risks for neurosurgical patients. Although current evidence suggests that remifentanil may reduce EA risk in non-cardiac settings, its preventive efficacy in patients undergoing intracranial surgery remains unclear.<br />Methods and Analysis: In this single-centre, randomised, double-blind, parallel-group prospective clinical trial, patients scheduled for elective craniotomy will be screened to confirm their eligibility. After surgery under general anaesthesia, patients will be assigned to groups to receive either remifentanil or placebo infusion on admission to the PACU. The remifentanil group will be given remifentanil infusion at a dose of 0.1 µg/(kg×min), whereas the control group will be given the same volume of normal saline. The primary outcome is the effect of remifentanil on EA incidence during the emergence period. Secondary outcomes include the following: time to regain consciousness, extubation time, total PACU duration, extubation comfort score measured by the modified Minogue Scale, postoperative pain intensity assessed using a Numerical Rating Scale, awakening quality and postoperative delirium assessed by alertness and orientation score, and a 3-Minute Diagnostic Interview for Confusion Assessment Method.<br />Ethics and Dissemination: The study protocol (V.4.0, dated 14 August 2025, No. 2025-0954) has been approved by the Institutional Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine and complies with the Declaration of Helsinki and relevant regulations for research involving human participants. Findings will be disseminated through peer-reviewed publications and conference presentations.<br />Trial Registration Number: ChiCTR2500096691.<br /> (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)
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  Data: <i>Keywords: </i>Anaesthesia in neurology; Emergence Delirium; Neurosurgery
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      – TitleFull: Effect of low-dose remifentanil infusion on emergence agitation after general anaesthesia in patients undergoing intracranial surgery: study protocol of a randomised controlled trial.
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