A Randomized-Controlled Trial of Conventional Pneumoinsufflation and Pressure-Barrier Insufflation at High and Low Pressures in Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
This study seeks to evaluate post-operative patient pain and quality of life, and intra-operative hemodynamic status and changes in inflammatory markers, with use of a pressure-barrier insufflator and conventional insufflator at high and low pneumoperitoneum pressure settings.
详细描述
This is a randomized-controlled double-blinded trial examining outcomes from total laparoscopic hysterectomies performed under low and high pressure pneumoperitoneum with either a novel pressure-barrier insufflator (AirSeal®) or conventional insufflator. All patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If eligible, a standard informed consent process will ensue.
All research activities will commence on the day of surgery, in the pre-operative preparation area. Enrolled subjects will undergo standard registration and pre-operative preparation by the staff preoperative nurse, including placement of intravenous access line and administration of standard pre-operative intravenous medications (typically ondansetron, dexamethasone, and ketorolac). While in the pre-operative area, and prior to any sedative drug administration by anesthesia, the patient will complete an 11-point Numeric Rating Scale (NRS) for baseline pain, as well as a baseline 18-question quality of life survey with the Abdominal Surgery Impact Scale (ASIS). Both study instruments will be self-administered by the patients and collected by the research team. A baseline blood collection will be performed in the pre-operative area by the research team assistant and sent for inflammatory markers.
The subject will be moved to the operating room and the anesthesia team will apply the pads for use with the Cheetah Non-Invasive Cardiac Output Monitoring (NICOM) system, in addition to other standard anesthesia monitoring equipment. The Cheetah NICOM will be activated for baseline measurements prior to anesthesia induction. Induction, intubation, and anesthesia administration will be performed according to standard practice by a dedicated group of anesthesia providers. A second set of hemodynamic measurements from the Cheetah NICOM will be measured after intubation, prior to pneumoperitoneum. A select group of anesthesia providers familiar with the protocol will administer anesthesia using non-depolarizing muscle relaxants continuously adjusted to be no less than one twitch during pneumoperitoneum.
Prior to any incision, preoperative prophylactic antibiotics and surgical sterile preparation will be performed per usual technique. Bilateral upper extremities will be placed in a tucked position, and no shoulder pads will be used in any case. An 18g peripheral IV (ideally antecubital) will be placed to allow intra-operative blood draws. This may be placed before or after anesthesia induction, but prior to arm tucking.
Randomization will occur after the patient is anesthetized, but prior to surgical start time to allow proper equipment to be opened on the surgical field without waste. Randomization will be into one of four groups with equal allocation to each (1:1:1:1 ratio):
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet the following inclusion criteria to be eligible for the study.
- •Understand and voluntarily sign an informed consent form.
- •Female gender ages 18-65
- •Scheduled for total laparoscopic hysterectomy for benign indications with or without oophorectomy (standard of care involves bilateral salpingectomy).
排除标准
- •Meeting any of the following exclusion criteria will make the subject ineligible for the study.
- •Anticipated removal of uterus through any route except vagina (transvaginal morcellation is acceptable)
- •Planned concomitant procedures including but not limited to resection of deep endometriosis, plastic surgery procedures, or bowel resection.
- •Daily narcotic pain medication use for greater than 30 days leading into surgery
- •Use of da Vinci® robot surgical assistance
结局指标
主要结局
Pain score
时间窗: 2 hours post-surgery
Numerical rating scale
次要结局
- Pain score on a NRS(1 day post-surgery)
- Narcotic usage(2 hours and 1 day post-surgery)
- Heart rate(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Mean arterial pressure(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Oxygen saturation(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- End tidal carbon dioxide(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Peak inspiratory pressure(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Stroke volume index(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Respiratory rate(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Total peripheral resistance(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Stroke volume variation(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Interleukin-6 (plasma)(Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery)
- Norepinephrine(Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery)
- Operative time(Intra-operative (procedure start to finish))
- Tidal volume(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Stroke volume(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Cardiac output(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Cardiac index(Intra-operative (1. prior to anesthesia induction; 2. after induction prior to incision; 3. with pneumoperitoneum prior to Trendelenburg; 4. 10 minutes after trendelenburg; 5. 30 minutes after trendelenburg; 6. 5 minutes after pneumoperitoneum release)
- Tumor necrosis factor-alpha (plasma)(Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery)
- Loss of pneumoperitoneum(Intra-operative (procedure start to finish))
- Epinephrine(Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery)
- Quality of life score based on the abdominal surgery impact scale(2 weeks post-surgery)
- C-reactive protein (plasma)(Baseline (pre-anesthesia), intra-operative (30 minutes after Trendelenburg), 2 hours post-surgery)
- Estimated blood loss(Intra-operative (procedure start to finish))
- Total complications(Within first 30 days after surgery)
- Conversion of low pneumoperitoneum to high pneumoperitoneum(Intra-operative (procedure start to finish))
研究者
Pamela Frazzini Padilla
Clinical Fellow
The Cleveland Clinic