Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

Study Overview
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Brief Summary
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To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery

Official Title
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Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

Conditions
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Hemodynamics, Liver, Terlipressin

Intervention / Treatment
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* Drug: terlipressin
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Any gender. ASA (American Society of Anesthesiologists) Classification( Class I-II) Patients undergoing major elective hepatobiliary surgery. Exclusion Criteria: Preoperative renal failure (GFR < 50 ml/min). Severe liver dysfunction (Child- turcotte -Pugh grade C). Hyponatremia (<132 mmol/l). Severe aortic regurgitation, severe mitral regurgitation, heart failure. Symptomatic coronary heart disease. Bradycardic arrhythmia (heart rate < 60/min). Peripheral artery occlusive disease (clinical stadium II-IV). Uncontrolled arterial hypertension (Blood pressure >160/100 mmHg despite intensive treatment). Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terlipressin<br>Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours. | Drug: terlipressin<br>* Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.<br>* Other names: glypressin;|
| Placebo Comparator: CONTROL<br>Patients receive the same volume of 0.9% saline in place of terlipressin for the same duration(50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours). | Drug: normal saline<br>* Patients receive 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours.<br>* Other names: 0.9 Nacl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| portal pressure changes | portal pressure changes in mmHg | intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on systemic vascular resistance | •Effect on systemic vascular resistance in dyne.s/cm5 | intraoperative period | 
| Renal impairment | Number of patients with renal impairment [defined as at least a doubling of serum creatinine or oliguria (<500 mL/24 hours)]. | for 3 days in the postoperative period | 
| Blood units transfused | Number of packed RBCs (red blood cells) units transfused | intraoperative period |