Sleep Quality - Comparing the Effect of Ondansetron or Dexamethasone Given as Routine Prophylaxis Intraoperatively to Prevent Post Operative Nausea and Vomiting
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Compare parent-reported sleep quality on day 1 post-op between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.
研究概览
简要总结
Nausea and vomiting are common complications after anaesthesia, and anaesthetists routinely give medications to prevent them. Dexamethasone and ondansetron are the two most commonly used agents and have a long safety record. However, their effects on sleep, behaviour, and overall recovery are not well studied. Understanding these will guide future care. The aim of this study is to determine if dexamethasone or ondansetron given during an anaesthetic affect post-operative sleep, behaviour and recovery in children.
Patients enrolled in the study will be randomised to receive either dexamethasone or ondansetron during their procedure. This randomisation will be blinded to patients, their families and their treating anaesthetist. Information about the patient's pain, recovery and sleep will be collected over 7 days post-operatively using online surveys.
A subset of patients will also be asked to complete additional pre-operative non-invasive monitoring using an oximeter and an actigraph to measure their sleep quality before and after surgery. In addition to the postoperative surveys, these patients will be asked to wear the oximeter and actigraph for 3 nights before and immediatey after surgery. Patients who are admitted overnight postoperatively will also have additional transcutaneous carbon dioxide monitoring on the night of their surgery.
详细描述
Postoperative nausea and vomiting (PONV) are a common complication after anaesthesia. Therefore, it is standard practice to administer either ondansetron and/or dexamethasone intraoperatively as prophylaxis. PONV affects up to 30-40% of the general surgical population and up to 80% of high-risk patients, making it one of the most distressing complications of the perioperative period.Uncontrolled PONV prolongs recovery room stay, increases unplanned hospital re-admissions, and is consistently identified by patients and families as one of the most undesirable aspects of the surgical experience. It was ranked in the top 10 research priorities in perioperative medicine in a recent large consumer engagement study involving over 350 children.
Ondansetron, a 5-HT3 receptor antagonist, and dexamethasone, a corticosteroid, are the two most widely used agents for PONV prophylaxis in paediatric anaesthesia, often administered in combination.Dexamethasone exerts well-documented glucocorticoid effects, including modulation of the hypothalamic-pituitary-adrenal (HPA) axis, suppression of endogenous cortisol secretion, and direct actions on brain structures involved in arousal and sleep regulation, including the hippocampus, hypothalamus, and limbic system.a single intraoperative dose of dexamethasone (0.1-0.5 mg/kg) has been shown to produce measurable HPA axis suppression lasting 24-48 hours postoperatively in children, as well as transient elevations in blood glucose and behavioural changes including hyperactivity, irritability, and emotional lability.
Sleep is a critical component of paediatric postoperative recovery. Disrupted postoperative sleep has been associated with increased pain perception, impaired immune function, heightened parental anxiety, and prolonged behavioural disturbance following surgery. Glucocorticoids are known to disrupt sleep architecture, including fragmentation of sleep, suppression of slow-wave sleep, and reductions in total sleep time. In children, the effects of a single perioperative dose of dexamethasone on sleep remain poorly characterised. In contrast, ondansetron does not directly affect the HPA axis or glucocorticoid receptors, and its central effects are limited primarily to 5-HT3 receptor blockade, with no established direct mechanism for sleep disruption. Postoperative negative behavioural changes (PNBC) in children, sometimes referred to as "new-onset behavioural problems", are a recognised sequela of paediatric anaesthesia and surgery, affecting up to 54% of children in the first 2 weeks following surgery. The potential role of perioperative dexamethasone in exacerbating these changes through glucocorticoid-mediated effects on the developing brain has not been systematically examined. Understanding whether the choice of PONV prophylaxis agent influences postoperative sleep quality and behaviour could have important implications for anaesthetic practice and family-centred postoperative care.
This study aims to investigate the impact of intraoperative intravenous dexamethasone vs ondansetron administered for prophylaxis of postoperative nausea and vomiting (PONV) on postoperative sleep, behaviour and recovery in children undergoing general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded trial
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2 - 15 years,
- •Undergoing general anaesthesia for minor ambulatory surgery or procedures with a maximum of 1 overnight stay postoperatively
- •ASA I or III
排除标准
- •Currently taking regular dexamethasone or ondansetron
- •Currently taking regular steroids, including inhaled corticosteroids
- •Anaesthetic plan to give dual PONV prophylaxis
- •Known hypersensitivity to the active substance or to any of the excipients listed
- •Language barriers impeding data collection
- •Department for Child Protection and Family Support is involved in their care
- •Planned admissions to the Paediatric Intensive Care Unit (PICU)
- •Oncology patients
- •Severe developmental delay
- •ASA III or above
- •Significant cardiorespiratory conditions
研究组 & 干预措施
Dexamethasone Group
Dexamethasone will be sourced from the hospital pharmacy as standard registered medications. The study drug will be prepared by independent clinical staff to ensure individualised, correct dosing. Dexamethasone will be administered intravenously at 0.2 mg/kg (maximum 8 mg) at the start of procedure.The patient-specific dose of the investigational product will be diluted to 2ml with normal saline to ensure blinding of the anaesthetist in charge of the patient. The trial will mimic this institutional standard practice by providing two syringes to every treating anaesthetist. The first syringe will contain the patient's dose of dexamethasone diluted to 2mL, the second syringe will contain 2mL of normal saline.
干预措施: Dexamethasone (IV) (Drug)
Ondansetron Group
Ondansetron will be administered intravenously at 0.15 mg/kg (maximum 4 mg) 15-30 min before the end of surgery. The dose will be diluted to 2ml with normal saline to ensure blinding by the anaesthetist. The study drug will be prepared by independent clinical staff to ensure individualised, correct dosing. The first syringe will contain 2mL of normal saline, the second syringe will contain the patient's dose of ondansetron diluted to 2mL.
干预措施: Ondansetron iv (Drug)
结局指标
主要结局
Compare parent-reported sleep quality on day 1 post-op between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.
时间窗: Sleep quality will be assessed on day 1 post-surgery
Parent-reported sleep quality will be measured on a 0 - 10 point scale, where 0 is terrible sleep and 10 is excellent sleep.
次要结局
- Compare parent-reported sleep quality preoperatively and on postoperative days 2,3,5 and 7 between children who received dexamethasone and children who received ondansetron intraoperatively.(Parent-reported preoperative sleep quality will be collected on the day of surgery and postoperatively on days 2,3,5 and 7.)
- Compare child-reported (if child is aged over 8 years) sleep quality on postoperative days 1, 2, and 7 between children receiving intravenous dexamethasone and children receiving intravenous ondansetron during their anaesthetic.(child reported sleep quality will be measure don days 1, 2, and 7 postoperatively)
- Compare parent reported postoperative recovery on postoperative days 1, 2, 3, 5, and 7 between children in the dexamethasone group and children in the ondasetron group(Postoperative recovery will be measured postoperative days 1, 2, 3, 5, and 7)
- Compare parent reported postoperative behaviour on postoperative days 1, 2, 3, 5, and 7 between children in the dexamethasone group and children in the ondasetron group(postoperative behaviour will be measured on postoperative days 1, 2, 3, 5, and 7)
- Compare parent reported average and maximum pain score on postoperative days 1, 2, 3, 5, and 7 or until the child has returned to normal function between children in the dexamethasone group and children in the ondasetron group(postoperative pain will be measured on days 1, 2, 3, 5 and 7 or until the child returns to normal function.)
- Comparison of sleep disturbances at baseline and 7 days post-surgery between children in the dexamethasone group and children in the ondasetron group(Sleep disturbance will be measured at baseline on the day of surgery in the pre-operative holding area and on postoperative day 7)
- Comparison of the incidence of early postoperative nausea and vomiting between children in the dexamethasone group and children in the ondansetron group(From PACU arrival until 6 hours postoperatively or hospital discharge, whichever comes first.)
- Comparison of the use of rescue medication for postoperative nausea and vomiting between children in the dexamethasone group and children in the ondansetron group(from PACU arrival until 6 hours postoperatively or hospital discharge, whichever comes first)
- Determine the impact of the Snoring, Trouble Breathing and Unrefreshed (STUBR) questionnaire on postoperative recovery(STUBR questionnaire will be administered preoperatively and recovery will be assessed on postoperative days 1,2,3,5, and 7)
- Determine the impact of the Snoring, Trouble Breathing and Unrefreshed (STUBR) questionnaire on postoperative sleep(Parent reported sleep quality will be measured on postopeative days 1,2,3,5, and 7. Child reported sleep quality (if the child is older than 8 years) will be measured on postoperative days 1,2, and 7.)
- Impact of sedative premedication on postoperative delirium(Delirium will be assessed from PACU arrival until PACU discharge criteria met)