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Pilot randomized trial of donepezil hydrochloride for delirium after hip fracture.

ABSTRACT: To determine whether donepezil hydrochloride can reduce the prevalence and severity of delirium in older adults undergoing hip fracture repair.Pilot double-masked randomized placebo-controlled trial.Large academic medical center.Sixteen individuals aged 70 and older with hip fracture.Donepezil 5 mg or placebo was randomly allocated and initiated within 24 hours of surgery, preoperatively or postoperatively. Daily treatment was continued for 30 days or until side effects or the clinical situation required termination.All outcomes were ascertained masked to treatment status. Information on drug tolerability and safety was obtained from the participant, nurse, and medical record. Delirium presence and severity were measured during daily hospital interviews and at 2, 4, and 6 weeks after surgery after a standardized assessment using the Confusion Assessment Method (CAM) and the Memorial Delirium Assessment Scale (MDAS).Participants in the donepezil and placebo arms had similar baseline characteristics. Participants in the donepezil arm experienced significantly more side effects. In longitudinal models, there were no significant differences between the donepezil and placebo arms with regard to delirium presence over time (odds ratio = 0.9, 95% confidence interval (CI) = 0.4-2.3) or delirium severity over time (effect size = -0.2 on 30-point MDAS scale, 95%CI = -1.5-1.2).Participants randomized to donepezil had no significant improvement in delirium presence or severity but experienced more side effects. Overall, sufficient evidence was not found from this pilot study to warrant a definitive Phase III trial.

SUBMITTER: Marcantonio ER

PROVIDER: S-EPMC3233977 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Pilot randomized trial of donepezil hydrochloride for delirium after hip fracture.

Marcantonio Edward R ER Palihnich Kerry K Appleton Paul P Davis Roger B RB

Journal of the American Geriatrics Society 20111101

<h4>Objectives</h4>To determine whether donepezil hydrochloride can reduce the prevalence and severity of delirium in older adults undergoing hip fracture repair.<h4>Design</h4>Pilot double-masked randomized placebo-controlled trial.<h4>Setting</h4>Large academic medical center.<h4>Participants</h4>Sixteen individuals aged 70 and older with hip fracture.<h4>Intervention</h4>Donepezil 5 mg or placebo was randomly allocated and initiated within 24 hours of surgery, preoperatively or postoperativel ...[more]

PMID: 22091574

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Project description:ImportancePostoperative delirium is the most common complication following major surgery in older patients. Intraoperative sedation levels are a possible modifiable risk factor for postoperative delirium.ObjectiveTo determine whether limiting sedation levels during spinal anesthesia reduces incident delirium overall.Design, setting, and participantsThis double-blind randomized clinical trial (A Strategy to Reduce the Incidence of Postoperative Delirum in Elderly Patients [STRIDE]) was conducted from November 18, 2011, to May 19, 2016, at a single academic medical center and included a consecutive sample of older patients (≥65 years) who were undergoing nonelective hip fracture repair with spinal anesthesia and propofol sedation. Patients were excluded for preoperative delirium or severe dementia. Of 538 hip fractures screened, 225 patients (41.8%) were eligible, 10 (1.9%) declined participation, 15 (2.8%) became ineligible between the time of consent and surgery, and 200 (37.2%) were randomized. The follow-up included postoperative days 1 to 5 or until hospital discharge.InterventionsHeavier (modified observer's assessment of sedation score of 0-2) or lighter (observer's assessment of sedation score of 3-5) propofol sedation levels intraoperatively.Main outcomes and measuresDelirium on postoperative days 1 to 5 or until hospital discharge determined via consensus panel using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria. The incidence of delirium was compared between intervention groups with and without stratification by the Charlson comorbidity index (CCI).ResultsOf 200 participants, the mean (SD) age was 82 (8) years, 146 (73%) were women, 194 (97%) were white, and the mean (SD) CCI was 1.5 (1.8). One hundred participants each were randomized to receive lighter sedation levels or heavier sedation levels. A good separation of intraoperative sedation levels was confirmed by multiple indices. The overall incident delirium risk was 36.5% (n = 73) and 39% (n = 39) vs 34% (n = 34) in heavier and lighter sedation groups, respectively (P = .46). Intention-to-treat analyses indicated no statistically significant difference between groups in the risk of incident delirium (log-rank test χ2, 0.46; P = .46). However, in a prespecified subgroup analysis, when stratified by CCI, sedation levels did effect the delirium risk (P for interaction = .04); in low comorbid states (CCI = 0), heavier vs lighter sedation levels doubled the risk of delirium (hazard ratio, 2.3; 95% CI, 1.1- 4.9). The level of sedation did not affect delirium risk with a CCI of more than 0.Conclusions and relevanceIn the primary analysis, limiting the level of sedation provided no significant benefit in reducing incident delirium. However, in a prespecified subgroup analysis, lighter sedation levels benefitted reducing postoperative delirium for persons with a CCI of 0.Trial registrationclinicaltrials.gov Identifier: NCT00590707.

Project description:BackgroundStrategies to protect the brain from postoperative delirium (POD) after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i) by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABA)A receptor and (ii) through beneficial anesthetic and organ-protective effects.Methods and designAn international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM), in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome) is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years) and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane).Trial registrationEudraCT Identifier: 2009-017153-35; ClinicalTrials.gov Identifier: NCT01199276.

Project description:ImportanceIn adults undergoing hip fracture surgery, regional anesthesia may reduce postoperative delirium, but there is uncertainty about its effectiveness.ObjectiveTo investigate, in older adults undergoing surgical repair for hip fracture, the effects of regional anesthesia on the incidence of postoperative delirium compared with general anesthesia.Design, setting, and participantsA randomized, allocation-concealed, open-label, multicenter clinical trial of 950 patients, aged 65 years and older, with or without preexisting dementia, and a fragility hip fracture requiring surgical repair from 9 university teaching hospitals in Southeastern China. Participants were enrolled between October 2014 and September 2018; 30-day follow-up ended November 2018.InterventionsPatients were randomized to receive either regional anesthesia (spinal, epidural, or both techniques combined with no sedation; n = 476) or general anesthesia (intravenous, inhalational, or combined anesthetic agents; n = 474).Main outcomes and measuresPrimary outcome was incidence of delirium during the first 7 postoperative days. Secondary outcomes analyzed in this article include delirium severity, duration, and subtype; postoperative pain score; length of hospitalization; 30-day all-cause mortality; and complications.ResultsAmong 950 randomized patients (mean age, 76.5 years; 247 [26.8%] male), 941 were evaluable for the primary outcome (6 canceled surgery and 3 withdrew consent). Postoperative delirium occurred in 29 (6.2%) in the regional anesthesia group vs 24 (5.1%) in the general anesthesia group (unadjusted risk difference [RD], 1.1%; 95% CI, -1.7% to 3.8%; P = .48; unadjusted relative risk [RR], 1.2 [95% CI, 0.7 to 2.0]; P = .57]). Mean severity score of delirium was 23.0 vs 24.1, respectively (unadjusted difference, -1.1; 95% CI, -4.6 to 3.1). A single delirium episode occurred in 16 (3.4%) vs 10 (2.1%) (unadjusted RD, 1.1%; 95% CI, -1.7% to 3.9%; RR, 1.6 [95% CI, 0.7 to 3.5]). Hypoactive subtype in 11 (37.9%) vs 5 (20.8%) (RD, 11.5; 95% CI, -11.0% to 35.7%; RR, 2.2 [95% CI, 0.8 to 6.3]). Median worst pain score was 0 (IQR, 0 to 20) vs 0 (IQR, 0 to 10) (difference 0; 95% CI, 0 to 0). Median length of hospitalization was 7 days (IQR, 5 to 10) vs 7 days (IQR, 6 to 10) (difference 0; 95% CI, 0 to 0). Death occurred in 8 (1.7%) vs 4 (0.9%) (unadjusted RD, -0.8%; 95% CI, -2.2% to 0.7%; RR, 2.0 [95% CI, 0.6 to 6.5]). Adverse events were reported in 106 episodes in the regional anesthesia group and 102 in the general anesthesia group; the most frequently reported adverse events were nausea and vomiting (47 [44.3%] vs 34 [33.3%]) and postoperative hypotension (13 [12.3%] vs 10 [9.8%]).Conclusions and relevanceIn patients aged 65 years and older undergoing hip fracture surgery, regional anesthesia without sedation did not significantly reduce the incidence of postoperative delirium compared with general anesthesia.Trial registrationClinicalTrials.gov Identifier: NCT02213380.

Project description:ObjectiveTo explore the effect of early intervention for perioperative delirium in older (> 60 years) hip fracture patients.MethodsThis prospective study enrolled hip fracture patients aged ≥60 years who were admitted into our hospital between July 2011 and August 2019. Hip fractures were classified according to the Arbeitsgemeinschaft für Osteo-synthesefragen (AO) classification. This study included patients with isolated hip fracture and excluded patients with pathological or peri prosthetic fracture or patients with multiple traumatic injuries and high-energy trauma. They were randomized to receive conventional orthopedic care group (n = 65) or comprehensive orthopedic care group including preoperative psychological counseling and preventative risperidone (n = 63). Daily assessment was based on patient interview with the CAM-CR, and delirium was diagnosed by the Delirium Rating Scale (DRS-R-98). The rate, severity and duration of perioperative delirium and the length of postoperative stay were analyzed.ResultsTotally 200 patients were screened for eligibility. Twenty patients were excluded due to alcohol abuse and 40 were excluded because of brain lesions on head CT. In addition, 12 patients were excluded because of impaired cognition. Finally 128 patients were enrolled. Their mean age was 75.3 ± 2.2 years for the comprehensive orthopedic care group and 73.5 ± 6.1 years for the conventional orthopedic care group, and 53.9% of the patients were female. Sixty-eight (53.1%) patients had intertrochanteric fracture, 39.8% patients had femoral head fracture, and 7.0% patients had subtrochanteric fracture. In addition, 58.6% patients underwent internal fixation and 41.4% patients received arthroplasty. In this study, 63 patients were randomized to the comprehensive orthopedic care group and 65 patients to the conventional orthopedic care group. The two groups were comparable in demographic and baseline characteristics (P > 0.05). The rate of perioperative delirium was significantly lower in the comprehensive care group vs the conventional care group (15.9% vs. 30.8%; P < 0.05). The comprehensive care group had significantly reduced length of postoperative hospital stay vs the conventional care group (11.3 ± 2.5 days vs. 14.2 ± 2.2 days, P < 0.01). The mean DRS-R-98 score was 7.1 ± 2.7 for the comprehensive care group, and was significantly lower than that of the conventional orthopedic care group (11.2 ± 3.0; P < 0.05).ConclusionsOur early intervention may reduce the incidence of perioperative delirium in elderly hip fracture patients (>60 years).

Project description:BackgroundAnabolic steroid has been suggested as a supplement during hip fracture rehabilitation and a Cochrane Review recommended further trials. The aim was to determine feasibility and preliminary effect of a 12-week intervention consisting of anabolic steroid in addition to physiotherapy and nutritional supplement on knee-extension strength and function after hip fracture surgery.MethodsPatients were randomized (1:1) during acute care to: 1. Anabolic steroid (Nandrolone Decanoate) or 2. Placebo (Saline). Both groups received identical physiotherapy (with strength training) and a nutritional supplement. Primary outcome was change in maximal isometric knee-extension strength from the week after surgery to 14 weeks. Secondary outcomes were physical performance, patient reported outcomes and body composition.ResultsSeven hundred seventeen patients were screened, and 23 randomised (mean age 73.4 years, 78% women). Target sample size was 48. Main limitations for inclusion were "not home-dwelling" (18%) and "cognitive dysfunction" (16%). Among eligible patients, the main reason for declining participation was "Overwhelmed and stressed by situation" (37%). Adherence to interventions was: Anabolic steroid 87%, exercise 91% and nutrition 61%. Addition of anabolic steroid showed a non-significant between-group difference in knee-extension strength in the fractured leg of 0.11 (95%CI -0.25;0.48) Nm/kg in favor of the anabolic group. Correspondingly, a non-significant between-group difference of 0.16 (95%CI -0.05;0.36) Nm/Kg was seen for the non-fractured leg. No significant between-group differences were identified for the secondary outcomes. Eighteen adverse reactions were identified (anabolic = 10, control = 8).ConclusionsEarly inclusion after hip fracture surgery to this trial seemed non-feasible, primarily due to slow recruitment. Although inconclusive, positive tendencies were seen for the addition of anabolic steroid.Trial registrationClinicaltrials.gov NCT03545347 .

Dataset Information

Pilot randomized trial of donepezil hydrochloride for delirium after hip fracture.

Publications

Pilot randomized trial of donepezil hydrochloride for delirium after hip fracture.

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