Effect of Transesophageal Echocardiography-guided Non-fluid Limited Combined Dobutamine Strategy on Hepatic Venous Blood Flow Spectrum in Patients Undergoing Laparoscopic Hepatectomy: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Variation of hepatic venous blood flow spectrum
研究概览
简要总结
Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group. In the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. To ensure preload, transesophageal echocardiography (TEE) will be used to monitor left ventricular end-diastolic volume (LVEDV) and stroke volume (SV). In the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed, and the liquid will be restricted according to the currently commonly used principle of low central venous pressure(LCVP), nitroglycerin can be used if necessary.
详细描述
Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group.
Dobutamine group: 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. The dose of dobutamine will be increased if the operating field grade exceeds Grade II. Monitoring LVEDV and SV with TEE to ensure preload: after admission, the patient will be given 3-4 mL /kg/h equilibrium fluid as background infusion. LVEDV and SV will be monitored using TEE every 30 minutes after anesthesia induction. If LVEDV<75mL or SV<45mL, 200mL colloidal fluid will be given within 5min.
Control group: 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed. According to the currently commonly used principle of LCVP, the fluid will be limited to 3-4 mL/kg/h after anesthesia induction. If the operating field grade exceeds Grade II, nitroglycerin will be injected intravenously for remedial purposes at a rate of 0.3-0.8μg/kg/min.
Dobutamine and nitroglycerin will be stopped after hemostasis, and the anesthesiologist will supplement the infusion according to his/her experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
There are five groups (Participant, surgeon, anesthesiologist, data collector, outcome evaluator).
Participants, surgeons, and outcome evaluators will be unaware of the grouping. Blinding will be maintained until data analysis is completed.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergo laparoscopic partial liver resection at West China Hospital from February 2024 to April 2024
- •aged 18 to 65 years
- •BMI<30kg/m2
- •liver function Child-pugh grade A to B
- •American Society of Anesthesiologists（ASA）grade Ⅰto Ⅲ.
排除标准
- •coronary heart disease
- •heart valvular disease
- •arrhythmia
- •stroke history
- •cirrhosis
- •esophageal varices
- •esophageal disease, stomach disease, previous esophageal or gastric surgery history
- •chronic kidney disease
- •coagulation dysfunction.
研究组 & 干预措施
Dobutamine group
In the dobutamine group, 3~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. To ensure preload, TEE will be used to monitor LVEDV and SV.
干预措施: Dobutamine hydrochloride, Injectable (Drug)
Control group
In the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed, and the liquid will be restricted according to the currently commonly used principle of LCVP, nitroglycerin can be used if necessary.
干预措施: 0.9% normal saline (Drug)
结局指标
主要结局
Variation of hepatic venous blood flow spectrum
时间窗: Intraoperative (after anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)
The method of TEE monitoring hepatic vein blood flow: The TEE probe will be inserted into the patient's esophagus near the gastric fundus to show the liver. Next the probe will be rotated to the right to show the short axis of the inferior vena cava and the hepatic vein. Then the probe angle will be adjusted to 30-40° to show the long axis of the inferior vena cava and the hepatic vein, and the junction of the inferior vena cava and the hepatic vein. To record the blood flow spectrum of the hepatic vein using pulsed Doppler ultrasound (PW mode), the sampling volume should be placed in the hepatic vein, approximately 1.5-2cm away from the inferior vena cava opening. The angle between the sound beam and the blood flow direction should be less than 30°. The blood flow spectrum variation refers to the spectrum change measured at each time point relative to the basic spectrum after anesthesia induction.
次要结局
- Postoperative liver function (TB, ALT, AST) levels(The first and third day after surgery.)
- Incidence of postoperative pulmonary complications(Up to 7days after surgery.)
- The dose of vasoactive drugs(Intraoperative (From anesthesia induction to the patient leaving the operating room.))
- Surgical field grade(Intraoperative (When the liver parenchyma is transected after the pringle maneuver.))
- Duration of intraoperative hypotension(Intraoperative (From anesthesia induction to the patient leaving the operating room.))
- Lactic acid(Intraoperative (after anesthesia induction, liver parenchyma transection is completed.))
- Loss of hemoglobin(Preoperative and the third day after surgery.)
- Intraoperative blood loss(intraoperative (Operation starts until hemostasis is completed.))
- The remedy rate(Intraoperative (The liver parenchyma is transected until hemostasis is completed.))
- Intraoperative urine volume(Intraoperative (anesthesia induction to the patient leaving the operating room.))
- Length of operation(Intraoperative (From the beginning to the end of the surgery.))
- Loss of albumin(Preoperative and the third day after surgery.)
- Length of postoperative hospitalization(Up to 2 weeks after surgery.)
- Ejection fraction(Intraoperative (anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.))
- Incidence of AKI(Within 3 days after surgery)
研究者
Peng Liang，MD
Professor
West China Hospital