Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Liang, Ph.D. | Contact | 18980602201 | liangpengwch@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Peng Liang, Ph.D. | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | 610041 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004280 | Dobutamine |
| D007267 | Injections |
| D000077330 | Saline Solution |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
Not provided
Not provided
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.
Not provided
Not provided
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.
|
|
| 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. |
|
|
| Surgical field grade |
Grade Ⅰ 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 Ⅱ 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 Ⅲ 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 Ⅳ 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.) |
| 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.) |
| 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.) |
| 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.) |
| 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.) |
| 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.) |
| 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.) |
| Length of operation | From the beginning to the end of the surgery. | Intraoperative (From the beginning to the end of the surgery.) |
| 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. |
| 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. |
| Postoperative liver function (TB, ALT, AST) levels | The liver function (TB, ALT, AST) levels after surgery. | The first and third day after surgery. |
| 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 |
| Incidence of postoperative pulmonary complications | Pulmonary complications include pulmonary infection, respiratory failure, and moderate or large pleural effusion. | Up to 7days after surgery. |
| Length of postoperative hospitalization | determined by the number of days from operation to discharge. | Up to 2 weeks after surgery. |
| D005021 |
| Ethylamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |