Effect of TEE-guided Non-fluid Limited Combined With Dobutamine on Hepatic Venous Blood Flow Spectrum

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Hepatectomy
• Intervention / Treatment: Drug: Dobutamine hydrochloride, Injectable; Drug: 0.9% normal saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Peng Liang, Ph.D.; Phone Number: 18980602201; Email: liangpengwch@scu.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital
      • Contact: Peng Liang, Ph.D.; Phone Number: 18980602201; Email: liangpengwch@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dobutamine hydrochloride, Injectable; In the 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.; Other Names: Dobutamine group
Placebo Comparator: 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.	Drug: 0.9% normal saline; In the 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.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of hepatic venous blood flow spectrum	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.	Intraoperative (after anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	Intraoperative blood loss can be calculated by adding the blood volume absorbed by gauze (8ml for small gauze, 25ml for medium gauze, and 50ml for large gauze) to the blood volume collected in the suction tank during the operation.	intraoperative (Operation starts until hemostasis is completed.)
Surgical field grade	Grade Ⅰ is defined as the inferior vena cava and hepatic veins are very relaxed, and the liver section has little blood seepage, which is very easy to operate. Grade Ⅱ is defined as the inferior vena cava and hepatic vein are relaxed, and the liver section has less blood seepage, which is easy to operate. Grade Ⅲ is defined as the inferior vena cava and hepatic vein are tense, and the liver section oozes more blood, which is difficult to operate. Grade Ⅳ is defined as the inferior vena cava and hepatic vein are obviously tense, and the liver section oozes a lot of blood, which is very difficult to operate.	Intraoperative (When the liver parenchyma is transected after the pringle maneuver.)
The remedy rate	During hepatic parenchyma dissection, if the operating field grade is greater than grade II, the dobutamine dose (3-6 μg/kg/min) will be increased in the dobutamine group, and nitroglycerin (0.3-0.8μg /kg/min) will be added in the control group.	Intraoperative (The liver parenchyma is transected until hemostasis is completed.)
Duration of intraoperative hypotension	Intraoperative hypotension is defined as SBP<90mmHg, or MAP<60mmHg, or MAP/SBP decreasing greater than 20% of the baseline value during the perioperative period.	Intraoperative (From anesthesia induction to the patient leaving the operating room.)
Ejection fraction	The ejection fraction will be measured by M-mode ultrasonography on the transgastric short-axis section of the left ventricle using TEE, recording the average value of three cardiac cycles.	Intraoperative (anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)
The dose of vasoactive drugs	When perioperative SBP<90mmHg or MAP< 65mmHg, vasoactive drugs will be administered by the anesthesiologist.	Intraoperative (From anesthesia induction to the patient leaving the operating room.)
Intraoperative urine volume	After anesthesia induction, all patients will undergo catheterization to record urine volume during the operation.	Intraoperative (anesthesia induction to the patient leaving the operating room.)
Lactic acid	Invasive blood pressure will be monitored by the radial artery after anesthesia induction, and blood gas analysis will be performed after anesthesia induction and hepatic parenchyma dissection.	Intraoperative (after anesthesia induction, liver parenchyma transection is completed.)
Length of operation	From the beginning to the end of the surgery.	Intraoperative (From the beginning to the end of the surgery.)
Loss of hemoglobin	Preoperative hemoglobin content minus the hemoglobin content on the third day after surgery equals hemoglobin loss.	Preoperative and the third day after surgery.
Loss of albumin	Preoperative albumin content minus the albumin content on the third day after surgery equals albumin loss.	Preoperative and the third day after surgery.
Postoperative liver function (TB, ALT, AST) levels	The liver function (TB, ALT, AST) levels after surgery.	The first and third day after surgery.
Incidence of AKI	AKI stage 1 is defined as serum creatinine(SCR) increases 1.5-2 times higher than the baseline. AKI stage 2 is defined as SCR is 2-3 times higher than the baseline. AKI stage 3 is defined as SCR increases by more than 3 times compared with the baseline.	Within 3 days after surgery
Incidence of postoperative pulmonary complications	Pulmonary complications include pulmonary infection, respiratory failure, and moderate or large pleural effusion.	Up to 7days after surgery.
Length of postoperative hospitalization	determined by the number of days from operation to discharge.	Up to 2 weeks after surgery.

Collaborators and Investigators

• Sponsor: Sichuan University
• Investigators: Study Director: Peng Liang, Ph.D., West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): April 7, 2024

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Estimated): January 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: 2023HX2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No