Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: terlipressin group group will receive terlipressin infusion one mg in 50 ml normal saline will be given over 30 minute as loading dose then will be maintained as infusion of 160 μg per hour (8 ml/h). |
Drug: Terlipressin
drug will be given after 30 minutes of induction of anesthesia
|
| Placebo Comparator: saline (control) group group will receive normal saline infusion 50 ml normal saline will be given over 30 minute as loading dose then will be maintained as infusion of (8 ml/h). |
Drug: Normal saline
drug will be given after 30 minutes as placebo in control group
|
Outcome Measures
Primary Outcome Measures
- cerebral oxygen saturation [one hour after infusion of drug]
regional oxygen saturation assessed by cerebral oxymetry with probes applied on forehead
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasr Alainy Hospital , Faculty of Medicine | Cairo | Egypt |
Sponsors and Collaborators
- Kasr El Aini Hospital
Investigators
- Study Director: ahmed mohamed mokhtar, M.D, kasralainy faculty of medicine, Cairo university
Study Documents (Full-Text)
None provided.More Information
Publications
- Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. Review. German.
- Czosnyka M, Brady K, Reinhard M, Smielewski P, Steiner LA. Monitoring of cerebrovascular autoregulation: facts, myths, and missing links. Neurocrit Care. 2009;10(3):373-86. doi: 10.1007/s12028-008-9175-7. Epub 2009 Jan 6. Review.
- Dhiman RK, Kurmi R, Thumburu KK, Venkataramarao SH, Agarwal R, Duseja A, Chawla Y. Diagnosis and prognostic significance of minimal hepatic encephalopathy in patients with cirrhosis of liver. Dig Dis Sci. 2010 Aug;55(8):2381-90. doi: 10.1007/s10620-010-1249-7. Epub 2010 May 28.
- Joshi B, Brady K, Lee J, Easley B, Panigrahi R, Smielewski P, Czosnyka M, Hogue CW Jr. Impaired autoregulation of cerebral blood flow during rewarming from hypothermic cardiopulmonary bypass and its potential association with stroke. Anesth Analg. 2010 Feb 1;110(2):321-8. doi: 10.1213/ANE.0b013e3181c6fd12. Epub 2009 Dec 11.
- Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21.
- N-113-2017