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临床试验/NCT06292065
NCT06292065已完成不适用

Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy

Nils Vlaeminck1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Prevalence of full stomach

研究概览

简要总结

Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) were first introduced as a therapeutic agent for type 2 diabetes mellitus but they are being increasingly used to target weight loss in obesity.

One of the mechanisms by which weight loss is achieved, is increased satiety and significantly delayed gastric emptying. Tachyphylaxis for this effect has been reported with chronic use of long acting GLP-1-RA (e.g. semaglutide) but this was based on the paracetamol absorption technique or 13C breath test. Recent clinical data suggests semaglutide use does increase perioperative gastric content.This creates uncertainty for anaesthetists who are, anecdotally, more frequently faced with patients who may or may not have full stomachs despite adhering to conventional fasting guidelines.

To address this issue the American Society of Anesthesiologists (ASA) has recently released guidelines in which it advises to hold GLP-1-RA for one day (if administered daily) or one week (if administered weekly).

However, these recommendations are based on sparse empirical evidence and they do not necessarily follow from the known pharmacokinetic properties of these drugs. Typically, GLP-1-RA are administered in increasing doses over several weeks until a therapeutic steady state is achieved. Meanwhile the elimination half-life of e.g. semaglutide is 7 days. This means that holding semaglutide for one day or even one week might not be enough to attenuate its therapeutic effect of delayed gastric emptying. On the other hand if semaglutide were to be held for e.g. 5 terminal half-lifes, this would mean an unpractical 5 weeks during which glycemic control may be worsened and after which semaglutide doses would have to be incrementally increased again. Besides, hyperglycaemia secondary to semaglutide cessation can also delay gastric emptying.

Further confounding the assessment of these patients there can be 'background' delayed gastric emptying in diabetic patients and more pronounced delayed gastric emptying in patients recently started on GLP-1-RA. The presence of gastro-intestinal symptoms (nausea, vomiting, dyspepsia, abdominal distension) might offer clinical information regarding increased gastric residue in this population.

Gastric ultrasound is a point-of-care clinical and research tool that has steadily gained popularity to assess gastric content in patients not compliant with fasting rules or with certain comorbidities. Clinical decisions can be made based on the visualised content (e.g. solids, fluids or nothing) or through calculation of gastric volume by measuring antral circumference. In this study the investigators will examine gastric contents in patients who are taking semaglutide and in patients who are not. The investigators will then evaluate whether there is a difference in the incidence of full stomachs and whether gastric ultrasound influenced the anaesthetic plan of the treating anaesthetist.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •for the semaglutide cohort are:
  • •Adults (>=18 years old)
  • •Semaglutide therapy for any indication (type 2 diabetes or weight loss)
  • •Semaglutide therapy at any dose
  • •Semaglutide therapy with any route of administration
  • •Semaglutide therapy administered daily or weekly
  • •Semaglutide therapy at any time since initiation
  • •Elective surgery of any kind for which general anaesthesia was planned preoperatively
  • •Adherence to current ASA recommendation regarding GLP-1-RA; i.e. holding semaglutide for 1 week if administered weekly or for 1 day if administered daily.
  • •Adherence to current ESAIC fasting guidelines; i.e. >2 hours for liquids and >6 hours for solid foods.
  • •Inclusion criteria for the control cohort are:
  • •Adults (>=18 years old)
  • •Elective surgery of any kind for which general anaesthesia was planned preoperatively
  • •Adherence to current ESAIC fasting guidelines; i.e. >2 hours for liquids and >6 hours for solid foods

排除标准

  • •for the semaglutide cohort are:
  • •Semaglutide not held in accordance with current ASA recommendation, i.e. held either longer or shorter than recommended.
  • •No adherence to current ESAIC fasting guideline
  • •Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias.
  • •Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis.
  • •Inability to assume the right lateral decubitus position
  • •Initial anaesthetic plan did not involve general anaesthesia, e.g. neuraxial or locoregional cases
  • •Exclusion criteria for the control cohort are:
  • •Semaglutide or other GLP-1-RA therapy
  • •No adherence to current ESAIC fasting guideline
  • •Presence of a contra-indication to gastric ultrasound; i.e. previous gastric surgery (e.g. partial gastrectomy, gastric bypass) or hiatal hernias
  • •Presence of comorbidities associated with delayed gastric emptying: scleroderma, systemic lupus erythematosus, hypothyroidism, Parkinson disease, cerebral palsy, and multiple sclerosis
  • •Inability to assume the right lateral decubitus position
  • •Initial anaesthetic plan does not involve general anaesthesia, e.g. locoregional cases

研究组 & 干预措施

Gastric Ultrasound

Experimental

Gastric ultrasound will be performed shortly before induction; i.e. in the preoperative room. The exam will be performed by the treating anaesthetist experienced with gastric ultrasound. The gastric antrum will be visualised in supine position followed by a second visualisation of the antrum in right lateral decubitus. In the latter position the cross-sectional area of the antrum (RIGHT-LAT CSA) will be measured and used to calculate the gastric volume using the [VOLUME (ML) = 27.0 + 14.6 X RIGHT-LAT CSA - 1.28 X AGE] formula. The patient will be considered to have a full stomach or positive gastric ultrasound if solid gastric content is visible in any visualisation of the antrum or if calculated liquid gastric content exceeds 1.5 ml/kg of total body weight.

干预措施: Point-of-care gastric ultrasound (Diagnostic Test)

结局指标

主要结局

Prevalence of full stomach

时间窗: Immediately preoperatively

The prevalence of a full stomach based on gastric ultrasound (solids visible in any visualisation or calculated liquid gastric content exceeding 1.5 ml/kg of total body weight) in patients taking semaglutide compared to controls

次要结局

  • Association between duration of cessation of semaglutide and 'full stomach'(Immediately preoperatively)
  • Frequency of changes to the anaesthetic plan(Immediately preoperatively)
  • Calculated gastric content(Immediately preoperatively)
  • Association between duration of semaglutide therapy at current dose and 'full stomach'(Immediately preoperatively)
  • Association between duration of cessation of semaglutide and calculated gastric content(Immediately preoperatively)
  • Association between HbA1c levels and 'full stomach'(Immediately preoperatively)
  • Association between vomiting and 'full stomach'(Immediately preoperatively)
  • association between semaglutide dose and 'full stomach'(Immediately preoperatively)
  • Association between frequency of semaglutide administration and 'full stomach'(Immediately preoperatively)
  • Association between time since onset of diabetes mellitus and 'full stomach'(Immediately preoperatively)
  • Frequency of perioperative aspiration(Immediately postoperatively)
  • Prevalence of gastric symptoms(Immediately preoperatively)
  • Association between dyspepsia and 'full stomach'(Immediately preoperatively)
  • Association between frequency of semaglutide administration and calculated gastric content(Immediately preoperatively)
  • Association between duration of semaglutide therapy and calculated gastric content(Immediately preoperatively)
  • Association between duration of semaglutide therapy at current dose and calculated gastric content(Immediately preoperatively)
  • Association between duration of semaglutide therapy and 'full stomach'(Immediately preoperatively)
  • Association between preoperative blood glucose levels and 'full stomach'(Immediately preoperatively)
  • Association between time since onset of diabetes mellitus and calculated gastric content(Immediately preoperatively)
  • Prevalence of solid gastric content(Immediately preoperatively)
  • Association between fasting time for liquids and 'full stomach'(Immediately preoperatively)
  • Association between fasting time for solids and 'full stomach'(Immediately preoperatively)
  • Association between nausea and 'full stomach'(Immediately preoperatively)
  • Association between abdominal distension and 'full stomach'(Immediately preoperatively)
  • association between semaglutide dose and calculated gastric content(Immediately preoperatively)
  • Association between preoperative blood glucose levels and calculated gastric content(Immediately preoperatively)
  • Association between HbA1c levels and calculated gastric content(Immediately preoperatively)

研究者

发起方
Nils Vlaeminck
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nils Vlaeminck

Principal investigator

University Hospital, Antwerp

研究点 (1)

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