Clinical trial NCT06210217: Effect of TEE-guided Non-fluid Limited Combined With Dobutamine on Hepatic Venous Blood Flow Spectrum
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Laparoscopic Hepatectomy
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the dobutamine group, TEE will guide fluid rehydration to ensure preload, and dobutamine will be injected intravenously. In the control group, fluid will be limited by the principle of LCVP and the same amount of normal saline will be injected intravenously.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Variation of hepatic venous blood flow spectrum
timeFrame: Intraoperative (after anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: intraoperative (Operation starts until hemostasis is completed.)
measure: Surgical field grade
timeFrame: Intraoperative (When the liver parenchyma is transected after the pringle maneuver.)
measure: The remedy rate
timeFrame: Intraoperative (The liver parenchyma is transected until hemostasis is completed.)
measure: Duration of intraoperative hypotension
timeFrame: Intraoperative (From anesthesia induction to the patient leaving the operating room.)
measure: Ejection fraction
timeFrame: Intraoperative (anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)
measure: The dose of vasoactive drugs
timeFrame: Intraoperative (From anesthesia induction to the patient leaving the operating room.)
measure: Intraoperative urine volume
timeFrame: Intraoperative (anesthesia induction to the patient leaving the operating room.)
measure: Lactic acid
timeFrame: Intraoperative (after anesthesia induction, liver parenchyma transection is completed.)
measure: Length of operation
timeFrame: Intraoperative (From the beginning to the end of the surgery.)
measure: Loss of hemoglobin
timeFrame: Preoperative and the third day after surgery.
measure: Loss of albumin
timeFrame: Preoperative and the third day after surgery.
measure: Postoperative liver function (TB, ALT, AST) levels
timeFrame: The first and third day after surgery.
measure: Incidence of AKI
timeFrame: Within 3 days after surgery
measure: Incidence of postoperative pulmonary complications
timeFrame: Up to 7days after surgery.
measure: Length of postoperative hospitalization
timeFrame: Up to 2 weeks after surgery.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Peng Liang, Ph.D.
role: STUDY_DIRECTOR
References: