NCT06210217

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopic Hepatectomy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-03-30
• Completion: 2024-04-07
• First posted: 2024-01-18
• Last updated: 2024-01-18

Locations

1 site across 1 country: China