A clinical trial on the acute effects of methadone and buprenorphine on actual driving and cognitive function of healthy volunteers

Abstract Background Although used extensively worldwide, the effects of general anaesthesia on the human brain remain largely elusive. Moreover, general anaesthesia may contribute to serious conditions or adverse events such as postoperative cognitive dysfunction and delirium. To understand the basic mechanisms of general anaesthesia, this project aims to study and compare possible de novo neuroplastic changes induced by two commonly used types of general anaesthesia, i.e. inhalation anaesthesia by sevoflurane and intravenously administered anaesthesia by propofol. In addition, we wish to to explore possible associations between neuroplastic changes, neuropsychological adverse effects and subjective changes in fatigue and well-being. Methods This is a randomised, participant- and assessor-blinded, cross-over clinical trial. Thirty healthy volunteers (male:female ratio 1:1) will be randomised to general anaesthesia by either sevoflurane or propofol. Multimodal magnetic resonance imaging (MRI) of the brain will be performed before and after general anaesthesia and repeated after 1 and 8 days. Each magnetic resonance imaging session will be accompanied by cognitive testing and questionnaires on fatigue and well-being. After a wash-out period of 4 weeks, the volunteers will receive the other type of anaesthetic (sevoflurane or propofol), followed by the same series of tests. Primary outcomes: changes in T1-weighted 3D anatomy and diffusion tensor imaging. Secondary outcomes: changes in resting-state functional magnetic resonance imaging, fatigue, well-being, cognitive function, correlations between magnetic resonance imaging findings and the clinical outcomes (questionnaires and cognitive function). Exploratory outcomes: changes in cerebral perfusion and oxygen metabolism, lactate, and response to visual stimuli. Discussion To the best of our knowledge, this is the most extensive and advanced series of studies with head-to-head comparison of two widely used methods for general anaesthesia. Recruitment was initiated in September 2019. Trial registration Approved by the Research Ethics Committee in the Capital Region of Denmark, ref. H-18028925 (6 September 2018). EudraCT and Danish Medicines Agency: 2018-001252-35 (23 March 2018). www.clinicaltrials.gov, ID: NCT04125121. Retrospectively registered on 10 October 2019.

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Clinical Trial in Healthy Volunteers and Subjects With CDK

Case Medical Research ◽

10.31525/ct1-nct03893799 ◽

2019 ◽

Author(s):

Keyword(s):

Clinical Trial ◽

Healthy Volunteers

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Clinical Trial to Evaluate the Safety and Pharmacokinetics of YHP1903 in Healthy Volunteers

Case Medical Research ◽

10.31525/ct1-nct04225052 ◽

2020 ◽

Author(s):

Keyword(s):

Clinical Trial ◽

Healthy Volunteers

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Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial

Trials ◽

10.1186/s13063-021-05355-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xiao-Lin Wei ◽

Ru-Zhen Yuan ◽

Yong-Mei Jin ◽

Shu Li ◽

Ming-Yue Wang ◽

...

Keyword(s):

Breast Cancer ◽

Quality Of Life ◽

Clinical Trial ◽

Cognitive Function ◽

Exercise Intervention ◽

Early Stage ◽

Early Stage Breast Cancer ◽

Pharmacological Intervention ◽

Control Group

Abstract Background More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancer undergoing chemotherapy. Method A single-blinded, randomized control trial was designed. The trial will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomly assigned to (1:1) the supervised Baduanjin group (5 times/week, 30 min each time) or the wait-list control group for 3 months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures including subjective and objective cognitive function, symptoms (fatigue, depression, and anxiety), and health-related quality of life at pre-intervention (T0), 8 weeks (T1), and 12 weeks (T2). The PCI score in the FACT-Cog as the primary cognitive outcome will be reported descriptively, while effect sizes and 95% confidence intervals (CIs) will be calculated. The collected data will be analyzed by using an intention-to-treat principle and linear mixed-effects modeling. Discussion This is the first randomized clinical trial to investigate whether Baduanjin exercise will have a positive role in improving cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive dysfunction and promote survivorship care among breast cancer survivors. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR2000033152. Registered on 22 May 2020

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Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers

Arquivos de Gastroenterologia ◽

10.1590/s0004-2803.2017v54n1-06 ◽

2017 ◽

Vol 54 (1) ◽

pp. 33-36 ◽

Cited By ~ 2

Author(s):

Paulo Cesar GOMES ◽

Cervantes CAPOROSSI ◽

Jose Eduardo AGUILAR-NASCIMENTO ◽

Ageo Mario Candido da SILVA ◽

Viviane Maeve Tavares de ARAUJO

Keyword(s):

Clinical Trial ◽

Healthy Volunteers ◽

Postoperative Recovery ◽

Gastric Volume ◽

Safe Procedure ◽

Abdominal Ultrasonography ◽

Residual Gastric Volume ◽

Potential Benefits ◽

The Mean ◽

To Receive

ABSTRACT BACKGROUND Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO)-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN) to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. OBJECTIVE In this study of safety, we aimed at investigating the residual gastric volume (RGV) 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. METHODS We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US) in 20 healthy volunteers (10 males and 10 females) after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards) of either CHO (12.5% maltodextrin) or CHO-GLN (12.5% maltodextrin plus 15 g GLN). Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. RESULTS The mean (SD) RGV observed after 8 hours fasting (13.56±13.25 mL) did not statistically differ (P>0.05) from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL) and 180 minutes (14.60±10.39 mL). The RGV obtained at 120 (15.63±18.83 mL) and 180 (13.65±10.27 mL) minutes after CHO-GLN beverage also was not significantly different from the fasting condition. CONCLUSION The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

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