The Multi-Strategy Intervention to Enhance Quality of Anesthesia Care for Obese Patients: A Factorial Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Substudy 1: Number of participants developing postoperative nausea and vomiting
研究概览
简要总结
The main objective of this study is to investigate the optimal anesthesia for obese patients undergoing bariatric surgery in the strategies of positive pulmonary ventilation, tracheal intubation technique, hemodynamic monitoring, and postoperative nausea and vomiting (PONV) prophylaxis, as the followed:
- To evaluate the effectiveness and adverse effect of intravenous dexamethasone for PONV prophylaxis
- To determine the safe inspiratory pressure to prevent the occurrence of gastric insufflation during facemask ventilation using point-of-care ultrasonography of antrum
- To compare the effectiveness and safety between video intubating stylet and video laryngoscope in the placement of tracheal tubes
- To apply minimally invasive CO monitors in guiding goal-directed hemodynamic therapy and assess its impact on major complications and postoperative recovery
详细描述
Substudy 1: An evaluation of the effect of intravenous dexamethasone on postoperative nausea and vomiting
At the operating room, participants will be initially placed in a ramped position and then moved into a reverse Trendelenburg position to achieve a 30-degree incline of the thorax before preoxygenation. Each participant will be randomly assigned 1:1, stratified by presence of diabetes mellitus, to one of each of the following two interventions: dexamethasone (8 mg intravenously) and placebo (0.9% sodium chloride). The envelopes of group allocation will be opened just before the induction of general anesthesia.
After preoxygenation using facemask with pure oxygen 10 l·min-1 until end-tidal fractional oxygen concentration in the expired air (EtO2) ≥ 80%, general anesthesia will be induced with propofol 1.5-2.0 mg·kg-1 ideal body weight and fentanyl 1-2 μg·kg-1 total body weight. Tracheal intubation will be facilitated with rocuronium 0.8-1.0 mg·kg-1 ideal body weight. After induction, a radial artery catheterization will be performed for continuous monitoring of arterial pressure and measurement of serum glucose. In the designated patients, 8 mg of dexamethasone or placebo will be given intravenously within 10 minutes after the induction of anesthesia. Anesthesia will be maintained with 2-3 vol% sevoflurane and 60% oxygen in nitrogen, whereas the fraction of inspired oxygen (FiO2) 0.8-1.0 will be used during pneumoperitoneum to ensure oxygen saturation higher than 92%. If the value of surgical pleth index (CARESCAPE B650 Monitor, GE Healthcare, Chicago, IL, USA) is more than 50 or heart rate or blood pressure increases by more than 20% from baseline values during surgery, an intravenous bolus of fentanyl 25 or 50 μg will be given. Besides, the concentration of sevoflurane can be adjusted as clinically appropriate.
After surgery, all participants will receive supplemental oxygen, and pain will be relieved with ketorolac 15 to 30 mg. The need for postoperative opioids will be at the discretion of the anesthesiologist, and the dose will be adjusted according to clinical needs. Participants who request rescue antiemetic therapy or who have an emetic episode will be given droperidol 1.25 mg. If symptoms persist, metoclopramide 10 mg will be administered.
Primary outcome is the incidence of PONV, which includes any nausea, emetic episodes (retching or vomiting), or both during the first 24 postoperative hour. At the 2nd and 24th postoperative hours, trained investigators who are blinded to the group allocation will record the number of emetic episodes, the time each one occurs, and self-reported worst nausea episode during the preceding duration on an 11-point scale (0: no nausea and 10: the most severe nausea).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years
- •Body mass index ≥ 30 kg·m-2
- •Undergoing laparoscopic sleeve gastrectomy at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan
排除标准
- •Pregnant or lactating women
- •Severe cardiopulmonary distress, including left ventricular ejection fraction < 40%, double or triple vessel disease, New York Heart Association functional classification ≥ 3, peripheral oxygen saturation by pulse oximetry (SpO2) < 90% in room air, and moderate to severe pulmonary hypertension.
- •Previous esophageal, gastric, or duodenal surgery.
- •Previous head and neck surgery or radiation therapy
- •Previous cervical spine injury
- •High-degree cardiac arrythmia, including atrial fibrillation and severe atrioventricular block
- •Use of cardiac pacemaker or automated implantable cardioverter defibrillator
- •Chronic kidney disease, stage ≥ 4 (estimated glomerular filtration rate < 30 ml·min-1)
- •Planned transferal to intensive care unit for mechanical ventilation
- •QTc prolongation determined by a standard 12-lead electrocardiogram
- •Patients using emetogenic or antiemetic drugs within 24 hours before surgery
- •Patients requiring rapid sequence induction or fiberoptic awake intubation
- •Patient refusal to participate
研究组 & 干预措施
Dexamethasone
In the designated patients, 8 mg of dexamethasone or placebo will be given intravenously within 10 minutes after the induction of anesthesia. Anesthesia will be maintained with 2-3 vol% sevoflurane and 60% oxygen in nitrogen, whereas the fraction of inspired oxygen (FiO2) 0.8-1.0 will be used during pneumoperitoneum to ensure oxygen saturation higher than 92%.
干预措施: Dexamethasone 8 mg (Drug)
Placebo (0.9% sodium chloride)
In the designated patients, 8 mg of dexamethasone or placebo will be given intravenously within 10 minutes after the induction of anesthesia. Anesthesia will be maintained with 2-3 vol% sevoflurane and 60% oxygen in nitrogen, whereas the fraction of inspired oxygen (FiO2) 0.8-1.0 will be used during pneumoperitoneum to ensure oxygen saturation higher than 92%.
干预措施: Placebo (0.9% sodium chloride) (Drug)
Inspiratory pressure (10 cmH2O)
After the loss of eyelash reflex, a Guedel oropharyngeal airway (Biçakcilar, Istanbul, Turkey) will be placed into the oral cavity to assure adequate mouth opening. A facemask will be applied firmly to the patient's face to ensure an adequate seal. A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea is determined by end-tidal capnography occurs, mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure, at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator.
干预措施: Applied inspiratory pressure (10, 15, 20, or 25 cmH2O) (Diagnostic Test)
Inspiratory pressure (15 cmH2O)
After the loss of eyelash reflex, a Guedel oropharyngeal airway (Biçakcilar, Istanbul, Turkey) will be placed into the oral cavity to assure adequate mouth opening. A facemask will be applied firmly to the patient's face to ensure an adequate seal. A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea is determined by end-tidal capnography occurs, mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure, at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator.
干预措施: Applied inspiratory pressure (10, 15, 20, or 25 cmH2O) (Diagnostic Test)
Inspiratory pressure (20 cmH2O)
After the loss of eyelash reflex, a Guedel oropharyngeal airway (Biçakcilar, Istanbul, Turkey) will be placed into the oral cavity to assure adequate mouth opening. A facemask will be applied firmly to the patient's face to ensure an adequate seal. A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea is determined by end-tidal capnography occurs, mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure, at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator.
干预措施: Applied inspiratory pressure (10, 15, 20, or 25 cmH2O) (Diagnostic Test)
Inspiratory pressure (25 cmH2O)
After the loss of eyelash reflex, a Guedel oropharyngeal airway (Biçakcilar, Istanbul, Turkey) will be placed into the oral cavity to assure adequate mouth opening. A facemask will be applied firmly to the patient's face to ensure an adequate seal. A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea is determined by end-tidal capnography occurs, mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure, at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator.
干预措施: Applied inspiratory pressure (10, 15, 20, or 25 cmH2O) (Diagnostic Test)
Video intubating stylet
A tracheal tube (ConvaTec, Berkshire, England, UK) in appropriate sizes is preloaded over the Trachway® video intubating stylet (TVI-4050, Markstein Sichtec Medical Corp, Taichung, Taiwan), which is introduced into oral cavity to visualize the epiglottis and guided to glottis via a monitor after full neuromuscular blockade is achieved.
干预措施: Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy (Device)
Video laryngoscopy
A tracheal tube is preloaded over a GlideRite® stylet, which is specifically designed to work with GlideScope® video laryngoscope (Verathon Medical, Bothell, WA, USA). GlideScope® blade size 3 (GS-3) or 4 (GS-4) is used in all patients.
干预措施: Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy (Device)
Direct laryngoscopy
Tracheal tubes are prepared with a hockey stick-shaped stylet, and direct laryngoscopy is performed using a size-3 or -4 Macintosh blade (Rüsch Inc., Duluth, GA, USA).
干预措施: Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy (Device)
Goal-directed hemodynamic therapy
Subjects of the GDHT group will be managed according to the ERAS algorithm utilizing ProAQT® parameters to maintain the cardiac index ≥ 2.5 l·min-1·m-2.61 In brief, if cardiac index < 2.5 l·min-1·m-2, a bolus of 150 ml of crystalloid fluid will be given until the stroke volume variation is < 10%. If cardiac index < 2.5 l·min-1·m-2 despite the stroke volume variation of ≥ 10% following fluid challenge, continuous intravenous infusion of dopamine 5-10 μg·kg-1·min-1 will be administered. If mean arterial pressure is < 70 mmHg despite cardiac index ≥ 2.5 l·min-1·m-2, intravenous infusion of norepinephrine 2-10 μg·min-1 will be used.
干预措施: Goal-directed hemodynamic therapy targeting cardiac index (Device)
结局指标
主要结局
Substudy 1: Number of participants developing postoperative nausea and vomiting
时间窗: The first 24 postoperative hour
Primary outcome is postoperative nausea and vomiting, which includes any nausea, emetic episodes (retching or vomiting), or both during the first 24 postoperative hour. At the 2nd and 24th postoperative hours, trained investigators who are blinded to the group allocation will record the number of emetic episodes, the time each one occurs, and self-reported worst nausea episode during the preceding duration on an 11-point scale (0: no nausea and 10: the most severe nausea).
Substudy 2: The threshold inspiratory pressure for gastric insufflation
时间窗: Within 2 min after induction of anesthesia
Primary outcome is the episode of gastric insufflation. The ultrasonographic diagnosis of gastric insufflation is defined as the presence of an acoustic shadow phenomenon and/or a comet-tail artifact into the antrum. A typical whoosh sound with gurgling while auscultating over the epigastrium defines the diagnosis of gastric insufflation by auscultation method.
Substudy 3: The best glottis visualization, graded according to Cormack and Lehane's classification
时间窗: From the induction of anesthesia to the 24th postoperative hours
Primary outcome is the best glottis visualization, graded according to Cormack and Lehane's classification with external laryngeal pressure applied. The minimum and maximum values of Cormack and Lehane's grade are I and IV, respectively. Glottic views graded as III or IV are regarded as difficult.
Substudy 4: Number of participants developing postoperative major complications
时间窗: Within 30 days after surgery
Primary outcome is a composite of major complications according to the European Perioperative Clinical Outcome definitions within 30 days after surgery, including myocardial ischemia or infarction, arrhythmia, acute kidney injury, gastrointestinal bleeding, anastomotic breakdown, surgical site infection, and hospital-acquired pneumonia. Any events of the above complications will be determined and analyzed aggregately and separately.
次要结局
未报告次要终点
研究者
YingHsuanTai
Principal Investigator
Taipei Medical University Shuang Ho Hospital