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

Laparoscopic Hepatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210217
• Other study ID #: 2023HX2017
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 1, 2024
• Est. completion date: April 7, 2024

Study information

• Verified date: January 2024
• Source: Sichuan University
• Contact: Peng Liang, Ph.D.
• Phone: 18980602201
• Email: liangpengwch[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: April 7, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?to ?.

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.

Related Conditions & MeSH terms

• Laparoscopic Hepatectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.)
Secondary	Surgical field grade	Grade ? 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 ? 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 ? 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 ? 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.)
Secondary	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.)
Secondary	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.)
Secondary	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.)
Secondary	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.)
Secondary	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.)
Secondary	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.)
Secondary	Length of operation	From the beginning to the end of the surgery.	Intraoperative (From the beginning to the end of the surgery.)
Secondary	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.
Secondary	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.
Secondary	Postoperative liver function (TB, ALT, AST) levels	The liver function (TB, ALT, AST) levels after surgery.	The first and third day after surgery.
Secondary	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
Secondary	Incidence of postoperative pulmonary complications	Pulmonary complications include pulmonary infection, respiratory failure, and moderate or large pleural effusion.	Up to 7days after surgery.
Secondary	Length of postoperative hospitalization	determined by the number of days from operation to discharge.	Up to 2 weeks after surgery.