Liver Transplantation, Terlipressin Adverse Reaction
Conditions
Brief summary
in our study the investigators aim to assess the effect of terlipressin on cerebral oxygenation monitored by cerebral oxymetry and cerebral blood flow measured by transcranial doppler.
Detailed description
All patients will receive 6ml /kg/h Ringer acetate solution as a maintenance intraoperative fluid. If pulse pressure variations (PPV) is more than 15%, the patient will be considered as fluid responder and will receive a 250-ml bolus of albumin 5% to maintain PPV ≤15%. Blood transfusion will be given based on a hemoglobin level (\< 7 g/dl) in both (control group) and (terlipressin group). Other blood products will be transfused guided by lab result; Fresh frozen plasma will be given when INR \> 2 and platelets will be given when platelets \<30.000/mm3. The patients will be randomly allocated into 2 groups; Group T (Terlipressin group) and group S (Normal saline 0.9%). For (terlipressin group) all patients will receive loading dose of terlipressin (1mg diluted with 50 ml of normal saline 0.9% solution over 30 min) and it will be maintained by continuous infusion at rate of 160 μg per hour (8 ml/h). For (control group) all patient will receive 50 ml of normal saline 0.9% solution over 30 min and will be maintained continuous infusion at rate of 8 ml/h. Drugs will be prepared by the nurse and the investigator will be blinded to the drug given.
Interventions
DRUGTerlipressin
drug will be given after 30 minutes of induction of anesthesia
DRUGNormal saline
drug will be given after 30 minutes as placebo in control group
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA II-IV undergoing orthotopic liver transplantation. * Age above 18 years.
Exclusion criteria
* Age below 18 years. * Patients on Terlipressin preoperative. * Patients known allergic to Terlipressin. * Portal vein thrombosis. * Ischemic heart disease. * Patients with T. bilirubin level above 7 mg/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cerebral oxygen saturation | one hour after infusion of drug | regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cerebral oxygen saturation | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead |
| resistive index of middle cerebral artery | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | assessed by trans cranial Doppler |
| peak velocity, end diastolic velocity of middle cerebral arteries | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | assessed by trans cranial Doppler |
| End diastolic velocity of middle cerebral arteries | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | assessed by trans cranial Doppler |
| Heart rate | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | — |
| Systolic blood pressure | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | — |
| Diastolic blood pressure | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | — |
| PH | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | assessed by arterial blood gases |
| PCo2 | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | assessed by arterial blood gases |
| Po2 | baseline 5 minutes after induction anesthesia,dissection phase 30 minutes after induction of anesthesia, 1 hour after drug infusion, 15 minutes after start of anhepatic phase, 5 minutes after reperfusion | assessed by arterial blood gases |
Countries
Egypt
Outcome results
None listed