Effect of Muscular Tissue Oxygen Saturation-Guided Management During Laparoscopic Hysterectomy on Postoperative Nausea and Vomiting: A Randomized Controlled Trial (iMODIPONV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Incidence of PONV within 24 hours after surgery
研究概览
简要总结
This randomized controlled trial is to investigate if SmtO2-guided management on top of the usual care, compared with the usual care only, during laparoscopic hysterectomy significantly reduces the incidence of PONV.
详细描述
Postoperative nausea and vomiting (PONV) remains prevalent despite the institution of various prophylactic measures. The incidence of PONV in female patients undergoing laparoscopic gynecological surgery is up to 50% with and 70% without the administration of antiemetics, respectively. The consequences of PONV range from patient discomforts, postoperative complications, prolonged hospitalization, to increased health care costs. Among the multiple risk factors, suboptimal gastrointestinal (GI) perfusion or oxygenation may be responsible for some cases of PONV; however, this speculation remains to be confirmed.5 Optimal tissue oxygenation, the balance between tissue oxygen consumption and supply, is essential for the integrity of any tissue bed that is metabolically active. However, GI oxygenation cannot be directly and continuously monitored in patients at this time. Whether there is an organ which can be used as a surrogate of the GI system, meaning that the tissue oxygenation of this surrogate organ not only can be monitored and that it also correlates with that of the GI system, is an intriguing question. Currently, tissue oxygenation can be measured using near-infrared spectroscopy (NIRS) in patients. The recent advancements of this technology enable the accurate monitoring of the oxygenation within many tissue beds depending on the location of the oximetry probe.
The recent cohort study demonstrated that there is a close relationship between muscular tissue oxygen saturation (SmtO2) and PONV in patients undergoing robotic laparoscopic hysterectomy (manuscript accepted and in production). Multiple thresholds based on threshold, AUC, and multivariable analyses are able to differentiate the risk of PONV. The following SmtO2 thresholds were found to correlate with a reduced risk of PONV: 20% above baseline; while the following thresholds correlate with an increased risk of PONV: 5% below baseline, 15% below baseline, and 20% below baseline, < 70%, < 65%, and < 60%. Taken together, our study suggests the potential therapeutic targets for PONV prophylaxis may be to maintain SmtO2 > 70% and above baseline.
In this study, the investigators aim to investigate if intraoperative care guided by SmtO2 monitoring reduces the incidence of PONV after laparoscopic hysterectomy.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Both patients and outcomes assessor are blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Elective laparoscopic procedure involving hysterectomy
排除标准
- •Refuse to participate
- •Emergent surgery
- •Bowel resection planned
- •Vaginal or abdominal (open) hysterectomy
- •Chemotherapy or radiotherapy before surgery
- •Significant neuro, cognitive, or psychologic disease: stroke with neurologic deficit, dementia, schizophrenia, or any condition that makes meaningful postoperative follow-ups impossible
- •Significant cardiovascular disease: low-output cardiac failure defined as a preoperative left ventricular ejection fraction < 30%, active coronary artery disease, symptomatic valvular disease, symptomatic arrhythmia with or without pacemaker and/or AICD placement
- •Significant pulmonary disease: COPD requiring home oxygen therapy, severe asthma requiring steroid treatment, other pulmonary conditions requiring home oxygen therapy
- •Severe hepatic dysfunction being evaluated for liver transplantation or with a Child-Pugh Class C classification
- •Severe renal dysfunction requiring renal replacement therapy
- •Muscular pathologies such as dystrophy, atrophy, and weakness
- •Skin conditions incompatible with the adhesive oximetry probe (e.g., delicate or tattooed skin)
- •Current or previous smoker
- •ASA Physical Score ≥ IV
研究组 & 干预措施
Intervention
In addition to usual care during surgery, the intraoperative management will be additionally managed based on the guidance of muscular tissue oxygen saturation and non-invasive hemodynamic monitoring.
干预措施: Muscular tissue oxygen saturation guided care (Device)
Control
Patients will receive the usual care. Muscular tissue oxygen saturation and non-invasive hemodynamic monitoring will be used but blinded to care givers.
结局指标
主要结局
Incidence of PONV within 24 hours after surgery
时间窗: up to 24 hours
Nausea: Nausea is defined as a subjective unpleasant sensation associated with the urge to vomit. Retching: Retching is defined as the labored, spastic, and rhythmic contraction of chest and abdominal muscles without expulsion of gastric contents. Vomiting: Vomiting is defined as the forceful expulsion of any gastric contents from the mouth. PONV: PONV refers to the occurrence of nausea, retching, and/or vomiting.
次要结局
- 30-day mortality(30 days)
- Incidence of early PONV(up to 6 hours)
- Time of GI recovery(up to 48 hours)
- Overall quality of recovery based on QoR-15 questionnaire(up to 24 hours)
- Time to mobilization(up to 48 hours)
- Score of sleep quality(up to 48 hours)
- In-hospital GI complications(up to 30 days)
- Length of hospital stay(up to 30 days)
- Rate of ICU admission(Up to 30 days)
- Severity of postoperative pain(up to 24 hours)
- Non-GI-related composite complications(up to 30 days)
研究者
Lingzhong Meng
Professor and Division Chief
Yale University