RESUMO
BACKGROUND: Dexmedetomidine was reported to reduce postoperative acute pain after neurosurgery. However, the efficacy of dexmedetomidine for preventing chronic incisional pain is uncertain. METHODS: This article is a secondary analysis of a randomized, double-blind, placebo-controlled trial. Eligible patients were randomly allocated to either the dexmedetomidine group or the placebo group. Patients assigned to the dexmedetomidine group were given a 0.6 µg kg -1 dexmedetomidine bolus followed by a 0.4 µg kg -1 h -1 maintenance dose until dural closure; placebo patients were given comparable amounts of normal saline. The primary end point was the incidence of incisional pain at 3 months after craniotomy evaluated by numerical rating scale scores and defined as any score >0. The secondary end points were postoperative acute pain scores, sleep quality, and Short-Form McGill Pain Questionnaire (SF-MPQ-2) at 3 months after craniotomy. RESULTS: From January 2021 to December 2021, a total of 252 patients were included in the final analysis: the dexmedetomidine group (n = 128) and the placebo group (n = 124). The incidence of chronic incisional pain was 23.4% (30 of 128) in the dexmedetomidine group versus 42.7% (53 of 124) in the placebo group (risk ratio, 0.55; 95% confidence interval, 0.38-0.80; P = .001). The overall severity of chronic incisional pain was mild in both groups. Patients in the dexmedetomidine group had lower acute pain severity on movement than those in the placebo group for the first 3 days after surgery (all adjusted P < .01). Sleep quality did not differ between groups. However, the SF-MPQ-2 total sensory ( P = .01) and neuropathic pain descriptor ( P = .023) scores in the dexmedetomidine group were lower than those in the placebo group. CONCLUSIONS: Prophylactic intraoperative dexmedetomidine infusion reduces the incidence of chronic incisional pain as well as acute pain score after elective brain tumor resections.
Assuntos
Dor Aguda , Analgésicos não Narcóticos , Neoplasias Encefálicas , Dor Crônica , Dexmedetomidina , Humanos , Dexmedetomidina/uso terapêutico , Analgésicos não Narcóticos/uso terapêutico , Dor Aguda/tratamento farmacológico , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/prevenção & controle , Dor Pós-Operatória/tratamento farmacológico , Neoplasias Encefálicas/cirurgia , Dor Crônica/diagnóstico , Dor Crônica/epidemiologia , Dor Crônica/prevenção & controle , Craniotomia/efeitos adversos , Método Duplo-CegoRESUMO
BACKGROUND: Delirium is common, especially after neurosurgery. Dexmedetomidine might reduce delirium by improving postoperative analgesia and sleep quality. We tested the primary hypothesis that dexmedetomidine administration during intracerebral tumour resection reduces the incidence of postoperative delirium. METHODS: This randomised, double-blind, placebo-controlled trial was conducted in two tertiary-care hospitals in Beijing. We randomised 260 qualifying patients to either dexmedetomidine (n=130) or placebo (n=130). Subjects assigned to dexmedetomidine were given a loading dose of 0.6 µg kg-1 followed by continuous infusion at 0.4 µg kg-1 h-1 until dural closure; subjects in the placebo group were given comparable volumes of normal saline. The primary outcome was the incidence of delirium, which was assessed with the Confusion Assessment Method twice daily during the initial 5 postoperative days. RESULTS: The average (standard deviation) age of participating patients was 45 (12) yr, duration of surgery was 4.2 (1.5) h, and patients assigned to dexmedetomidine were given an average of 126 (45) µg of dexmedetomidine. There was less delirium during the initial 5 postoperative days in patients assigned to dexmedetomidine (22%, 28 of 130 patients) than in those given placebo (46%, 60 of 130 patients) with a risk ratio of 0.51 (95% confidence interval: 0.36-0.74, P<0.001). Postoperative pain scores with movement, and recovery and sleep quality were improved by dexmedetomidine (P<0.001). The incidence of safety outcomes was similar in each group. CONCLUSIONS: Prophylactic intraoperative dexmedetomidine infusion reduced by half the incidence of delirium during the initial 5 postoperative days in patients recovering from elective brain tumour resection. CLINICAL TRIAL REGISTRATION: NCT04674241.
Assuntos
Neoplasias Encefálicas , Delírio , Dexmedetomidina , Delírio do Despertar , Humanos , Dexmedetomidina/uso terapêutico , Delírio/etiologia , Dor Pós-Operatória/prevenção & controle , Dor Pós-Operatória/tratamento farmacológico , Neoplasias Encefálicas/cirurgia , Método Duplo-CegoRESUMO
INTRODUCTION: Postoperative delirium (POD) is a common complication, and it has a high incidence in neurosurgery patients. Awake craniotomy (AC) has been widely performed in patients with glioma in eloquent and motor areas. Most of the surgical procedure is frontotemporal craniotomy, and the operation duration has been getting longer. Patients undergoing AC are high-risk populations for POD. Dexmedetomidine (Dex) administration perioperatively might help to reduce the incidence of POD. The purpose of this study is to investigate the effect of Dex on POD in patients undergoing AC. METHODS: The study is a prospective, single-center, double-blinded, paralleled-group, randomized controlled trial. Patients undergoing elective AC will be randomly assigned to the Dex group and the control group. Ten minutes before urethral catheterization, patients in the Dex group will be administered with a continuous infusion at a rate of 0.2 µg/kg/h until the end of dural closure. In the control group, patients will receive an identical volume of normal saline in the same setting. The primary outcome will be the cumulative incidence and severity of POD. It will be performed by using the confusion assessment method in the first 5 consecutive days after surgery. Secondary outcomes include quality of intraoperative awareness, stimulus intensity of neurological examination, pain severity, quality of recovery and sleep, and safety outcomes. DISCUSSION: This study is to investigate whether the application of Dex could prevent POD in patients after undergoing AC and will provide strong evidence-based clinical practice on the impact of intraoperative interventions on preventing POD in AC patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05195034. Registered on January 18, 2022.
Assuntos
Dexmedetomidina , Delírio do Despertar , Humanos , Craniotomia/efeitos adversos , Dexmedetomidina/uso terapêutico , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , VigíliaRESUMO
INTRODUCTION: Postoperative delirium (POD) is a common surgical complication. The incidence is 19% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine (DEX) reduced the incidence of delirium after non-cardiac surgery in elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. METHODS AND ANALYSIS: This is a randomised, double-blinded, paralleled-group and controlled trial. Patients older than 65 years and scheduled for elective craniotomy will be randomly assigned to the DEX group and the control group. After endotracheal intubation, patients in the DEX group will be administered with continuous DEX infusion at rate of 0.4 µg/kg/hour until the surgical haemostasis. In the control group, patients will receive the identical volume of normal saline in the same setting. The primary outcome is the incidence of POD during the first 5 days. Delirium will be evaluated through a combination of three methods, including the Richmond Agitation Sedation Scale (RASS), the confusion assessment method for ICU (CAM-ICU) and the 3 min diagnostic interview for CAM (3D-CAM). The RASS, CAM-ICU and 3D-CAM will be evaluated two times per day (08:00-10:00 and 18:00-20:00 hours) during the first postoperative 5 days. Secondary outcomes include pain severity score, quality of recovery, quality of sleep, cognitive function, psychological health state, intraoperative data, physiological status, length of stay in ICU and hospital, hospitalisation costs, non-delirium complications, and 30-day all-cause mortality. ETHICS AND DISSEMINATION: The protocol (V.4.0) has been approved by the medical ethics committee of Beijing Tiantan Hospital, Capital Medical University (KY2021-194-03). The findings of the study will be disseminated in a peer-reviewed journal and at a scientific conference. TRIAL REGISTRATION NUMBER: NCT05168280.
Assuntos
Dexmedetomidina , Delírio do Despertar , Humanos , Idoso , Dexmedetomidina/uso terapêutico , Delírio do Despertar/induzido quimicamente , Método Duplo-Cego , Unidades de Terapia Intensiva , Craniotomia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: At some level, intraoperative hypotension causes strokes. Elderly neurosurgical patients are presumably at especially high risk. We tested the primary hypothesis that intraoperative hypotension is associated with postoperative stroke in older patients undergoing brain tumor resection. METHODS: Patients >65 years old who had elective craniotomy for tumor resections were included. The primary exposure was the area under the threshold of intraoperative hypotension. The primary outcome was newly diagnosed ischemic stroke within 30 days, confirmed by scheduled brain imaging. RESULTS: Among 724 eligible patients, 98 (13.5%) had strokes within 30 days after surgery, 86% of which were clinically silent. Curves of lowest mean arterial pressure versus stroke incidence suggested a threshold at 75 mm Hg. Area under the threshold of mean arterial pressure below 75 mm Hg was therefore incorporated into multivariable modeling. There was no association of area below 75 mm Hg and stroke (adjusted odds ratio, 1.00; 95% confidence interval, 1.00-1.00). The adjusted odds ratio for area below 75 mm Hg between 1 and 148 mm Hg × minutes was 1.21 (95% confidence interval, 0.23-6.23). When the area below 75 mm Hg exceeded 1117 mm Hg × minutes, the association remained insignificant. In contrast, malignant tumor and history of previous stroke or myocardial ischemia were associated with strokes. CONCLUSIONS: Postoperative strokes were common in older patients who underwent brain tumor resection, with about 14% having ischemic cerebrovascular events within 30 days, of which 86% were clinically silent. Malignant brain tumors and previous ischemic vascular events were associated with postoperative strokes, but area under 75 mm Hg was not.
Assuntos
Neoplasias Encefálicas , Hipotensão , Acidente Vascular Cerebral , Humanos , Idoso , Estudos Retrospectivos , Hipotensão/etiologia , Hipotensão/complicações , Estudos de Coortes , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/complicações , Neoplasias Encefálicas/complicações , Neoplasias Encefálicas/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologiaRESUMO
INTRODUCTION: The incidence of covert stroke and cognitive dysfunction has gradually increased due to an ageing population. Recently, a prospective cohort study reported perioperative covert stroke was associated with an increased risk of postoperative cognitive dysfunction (POCD) 1 year after non-cardiac surgery. However, the mechanism remains unclear. METHODS AND ANALYSIS: This is a prospective observational trial aiming to investigate the cumulative incidence of perioperative covert stroke and test the hypothesis that perioperative covert stroke associates with POCD in elderly patients undergoing non-cardiac and non-neurological surgery. Data on risk factors, brain MRI, cognitive function evaluation and serum immune-inflammatory cytokines will be collected and analysed. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (reference number: KY2017-027-02). The results of this study will be disseminated through presentations at scientific conferences and publication in scientific journals. TRIAL REGISTRATION NUMBER: NCT03081429.
Assuntos
Cognição/fisiologia , Disfunção Cognitiva/epidemiologia , Complicações Pós-Operatórias , Acidente Vascular Cerebral/epidemiologia , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Idoso , Encéfalo/diagnóstico por imagem , China/epidemiologia , Disfunção Cognitiva/diagnóstico , Disfunção Cognitiva/etiologia , Feminino , Humanos , Incidência , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Estudos Prospectivos , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/etiologiaRESUMO
INTRODUCTION: Recent studies have shown that deep anaesthesia is associated with poor outcomes. However, no randomised controlled trials have been conducted to test the causality in patients undergoing brain tumour resection. METHODS AND ANALYSIS: DEPTH is a multicenter, randomised, parallel-group, blind trial. The depth of general anaesthesia will be monitored using the bispectral index (BIS). Patients elected for supratentorial tumour resection will be randomly allocated to the deep or the light anaesthesia group in which the target BIS value is 35 or 50, respectively. BIS will be maintained at the target value for more than 90% of the total anaesthesia period. The primary outcome is the disability-free survival rate at postoperative 30 days and 1 year. The secondary outcomes are the mortality and morbidity within 30 days after surgery. ETHICS APPROVAL AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medicine University. The reference number is KY2016-059-02. The results of this study will be disseminated through presentations at scientific conferences and publication in scientific journals. TRIAL REGISTRATION: NCT03033693.