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

NCT06210217 | Unknown Early Phase 1

• 1 other identifier: 2023HX2017
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Hepatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Intraoperative blood loss

  intraoperative (Operation starts until hemostasis is completed.)

• Surgical field grade

  Intraoperative (When the liver parenchyma is transected after the pringle maneuver.)

• The remedy rate

  Intraoperative (The liver parenchyma is transected until hemostasis is completed.)

• Duration of intraoperative hypotension

  Intraoperative (From anesthesia induction to the patient leaving the operating room.)

• Ejection fraction

  Intraoperative (anesthesia induction, 10 minutes after the administration of dobutamine/normal saline, after pneumoperitoneum is established, and after hemostasis is completed.)

Study Arms (2)

Dobutamine group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Dobutamine hydrochloride, Injectable DRUG

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.

Also known as: Dobutamine group

Dobutamine group

0.9% normal saline DRUG

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.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Dobutamine; Injections; Saline Solution; Control Groups

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Peng Liang, Ph.D.

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Peng Liang, Ph.D.

CONTACT

18980602201; liangpengwch@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: There are five groups (Participant, surgeon, anesthesiologist, data collector, outcome evaluator). Participants, surgeons, and outcome evaluators will be unaware of the grouping. Blinding will be maintained until data analysis is completed.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 18, 2024
• Study Start: February 1, 2024
• Primary Completion: March 30, 2024
• Study Completion: April 7, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)