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Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial.

ABSTRACT: BACKGROUND: The study determined the one year incidence of post operative cognitive decline (POCD) and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age) undergoing elective orthopaedic or abdominal surgery. METHODS AND TRIAL DESIGN: The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. RESULTS: In the 52 week prospective cohort study (192 surgical patients and 138 controls), mild (?(2) = 17.9 p<0.0001), moderate (?(2) = 7.8 p = 0.005) and severe (?(2) = 5.1 p = 0.02) POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control). In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher's Exact Test p = 0.018, ?(2) = 5.1 p = 0.02 and ?(2) = 5.9 p = 0.015), and moderate POCD was reduced at 1 and 52 weeks (?(2) = 4.4 p = 0·037 and ?(2) = 5.4 p = 0.02). In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z = -2.1 p = 0.03, MWU Z = -2.7 p = 0.004, MWU Z = -3.0 p = 0.005), in MMSE at one and 52 weeks (MWU Z = -2.9 p = 0.003, MWU Z = -3.3 p = 0.001), and in executive function at 12 and 52 weeks (Trail Making MWU Z = -2.4 p = .0.018, MWU Z = -2.4 p = 0.019). CONCLUSION: POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN39503939.

SUBMITTER: Ballard C

PROVIDER: S-EPMC3376123 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial.

Ballard Clive C Jones Emma E Gauge Nathan N Aarsland Dag D Nilsen Odd Bjarte OB Saxby Brian K BK Lowery David D Corbett Anne A Wesnes Keith K Katsaiti Eirini E Arden James J Amoako Derek D Prophet Nicholas N Purushothaman Balaji B Green David D

PloS one 20120615 6

<h4>Background</h4>The study determined the one year incidence of post operative cognitive decline (POCD) and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age) undergoing elective orthopaedic or abdominal surgery.<h4>Methods and trial design</h4>The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and ...[more]

PMID: 22719840

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Project description:IntroductionPost-operative cognitive dysfunction (POCD) is frequent in patients older than 60 years undergoing major non-cardiac surgery, and increases both morbidity and mortality. Anesthetic drugs may exert neurotoxic effects and contribute to the genesis of POCD. The hypothesis of the POCD-ELA trial was that closed-loop target-controlled infusion of propofol and remifentanil could reduce the occurrence of POCD by decreasing the risk of excessive depth of anesthesia and the dose of anesthetic drugs.Methods and analysisWe designed a single-center, single-blind, randomized, controlled, parallel trial and aim to include 204 patients aged >60 years undergoing elective major non-cardiac surgery. Patients will be randomized to receive closed-loop versus manual target-controlled infusion of propofol and remifentanil guided by bispectral index monitoring. Cognitive assessment will be performed the day before surgery (baseline) and within 72 hours after surgery, using a battery of validated neuropsychological tests. The primary outcome is the incidence of POCD within 72 hours after surgery. POCD is defined as a Z-score value > 1.96 for at least 2 different tests or a Z-score composite value >1.96. The calculation of the Z-score is based on data from an age-matched control population who did not undergo surgery or general anesthesia.Ethics and disseminationThis study was approved by the Ethics Committee (Comité de Protection des Personnes Est-II) and authorized by the French Health Products Agency (Agence Nationale de Sécurité des Médicaments, Saint-Denis, France). The University Hospital of Besancon is the trial sponsor and the holder of all data and publication rights. Results of the study will be submitted for publication in a peer-review international medical journal and for presentation in abstract (oral or poster) in international peer-reviewed congresses.RegistrationThe trial is registered with ClinicalTrials.gov (Identifier: NCT02841423, principal investigator: Prof Emmanuel Samain, date of registration: July 22, 2016). Last amendment of protocol: version 8.0 April 2018.

Project description:BackgroundPrevious meta-analysis of heterogeneous surgical cohorts demonstrated reduction in postoperative pain with perioperative intravenous dexamethasone, but none have addressed adults undergoing elective abdominal surgery. The aim of this study was to determine the impact of intravenous perioperative dexamethasone on postoperative pain in adults undergoing elective abdominal surgery under general anaesthesia.MethodsThis review was prospectively registered on the international prospective register of systematic reviews (CRD42020176202). Electronic databases Medical Analysis and Retrieval System Online (MEDLINE), Exerpta Medica Database (EMBASE), (CINAHL) Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and trial registries were searched to January 28 2021 for randomised controlled trials, comparing dexamethasone to placebo or alternative antiemetic, that reported pain. The primary outcome was pain score, and secondary outcomes were time to first analgesia, opioid requirements and time to post-anaesthesia care unit (PACU) discharge.ResultsFifty-two studies (5768 participants) were included in the meta-analysis. Pain scores ≤ 4 hour (h) were reduced in patients who received dexamethasone at rest (mean difference (MD), - 0.54, 95% confidence interval (CI) - 0.72 to - 0.35, I2 = 81%) and on movement (MD - 0.42, 95% CI - 0.62 to - 0.22, I2 = 35). In the dexamethasone group, 4-24 h pain scores were less at rest (MD - 0.31, 95% CI - 0.47 to - 0.14, I2 = 96) and on movement (MD - 0.26, 95% CI - 0.39 to - 0.13, I2 = 29) and pain scores ≥ 24 h were reduced at rest (MD - 0.38, 95% CI - 0.52 to - 0.24, I2 = 88) and on movement (MD - 0.38, 95% CI - 0.65 to - 0.11, I2 = 71). Time to first analgesia (minutes) was increased (MD 22.92, 95% CI 11.09 to 34.75, I2 = 98), opioid requirements (mg oral morphine) decreased (MD - 6.66, 95% CI - 9.38 to - 3.93, I2 = 88) and no difference in time to PACU discharge (MD - 3.82, 95% CI - 10.87 to 3.23, I2 = 59%).ConclusionsPatients receiving dexamethasone had reduced pain scores, postoperative opioid requirements and longer time to first analgesia. Dexamethasone is an effective analgesic adjunct for patients undergoing abdominal surgery.

Project description:BackgroundPatients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.Methods/designA two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy.Trial registrationCurrent Controlled Trials ISRCTN00525237.

Project description:IntroductionSeveral immunonutritional supplements have recently been developed. However, improvements in preoperative immunonutritional conditions using these supplements have not been analyzed in patients undergoing thoracic surgery.MethodsThis prospective, single-arm, single-institution pilot study involved patients planning to undergo thoracic surgery. Forty adults with a poor preoperative immunonutritional status were enrolled. The patients freely selected one of three oral immunonutritional supplements (IMPACTⓇ, MEINⓇ, or AboundⓇ) and started taking it on an outpatient basis from 7 to 14 days before thoracic surgery. The primary endpoint was the rate of improvement in three immunonutritional parameters on the hospitalization day: body mass index (BMI), prognostic nutritional index (PNI), and geriatric nutritional risk index (GNRI). These improvement rates were compared with those of a matched historical control group.ResultsThe PNI and GNRI improvement rates were significantly higher in the immunonutritional support group than in the control group (PNI: 103.1% ± 0.6% vs. 98.9% ± 1.3%, p = 0.0391; GNRI: 101.7% ± 0.8% vs. 99.3% ± 0.8%, p = 0.0266), although there was no significant difference in the BMI improvement rate (101.0% ± 0.6% vs. 100.2% ± 0.7%, p = 0.3626). The PNI and GNRI improvement rates were significantly higher in the IMPACTⓇ support group than in the control group (PNI: 104.5% ± 2.4% vs. 98.9% ± 1.3%, p = 0.0212; GNRI: 101.6% ± 1.1% vs. 99.3% ± 0.8%, p = 0.0415).ConclusionsThe present study revealed that short-term preoperative immunonutritional support can actually improve immunonutritional parameters immediately before surgery. In particular, preoperative immunonutritional support using IMPACTⓇ supplementation might be the most promising agent in patients with a poor immunonutritional condition undergoing elective thoracic surgery.Trial registrationUniversity Hospital Medical Information Network 000035851.

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Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial.

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Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial.

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