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

S

Sichuan University

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Laparoscopic Hepatectomy

Treatments

Drug: 0.9% normal saline
Drug: Dobutamine hydrochloride, Injectable

Study type

Interventional

Funder types

Other

Identifiers

NCT06210217
2023HX2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

51 participants in 2 patient groups, including a placebo group

Dobutamine group
Experimental group
Description:
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.
Treatment:
Drug: Dobutamine hydrochloride, Injectable
Control group
Placebo Comparator group
Description:
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.
Treatment:
Drug: 0.9% normal saline

Trial contacts and locations

1

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Central trial contact

Peng Liang, Ph.D.

Data sourced from clinicaltrials.gov

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