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Trial record 8 of 9 for:    "Liver Cirrhosis" | "Propofol"

Effects of Desflurane Versus Propofol on Hemostasis During Splenectomy

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ClinicalTrials.gov Identifier: NCT02079064
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Yasser Mostafa Samhan, Theodor Bilharz Research Institute

Brief Summary:
The aim of this prospective randomized study is to evaluate the perioperative effects of inhalational anesthesia (desflurane) and intravenous anesthesia (propofol) on hemostasis in patients undergoing splenectomy with liver cirrhosis guided by the new technology (ROTEM) and the traditional laboratory hemostatic markers.

Condition or disease Intervention/treatment Phase
Status; Splenectomy Drug: Desflurane Drug: Propofol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Effect of Desflurane Versus Total Intravenous Anesthesia With Propofol on Hemostasis Guided by Thromboelastometry in Splenectomy With Liver Cirrhosis.
Study Start Date : January 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Desflurane
Desflurane at 1 MAC and
Drug: Desflurane
Inhalational anesthetic
Other Name: Suprane

Experimental: propofol
propofol TCI (target controlled infusion) infusion of to keep a target plasma concentration between 2 and 5 µg ml-1
Drug: Propofol
Intravenous anesthetic that can be given by continuous infusion
Other Name: Diprivan




Primary Outcome Measures :
  1. maximum clot firmness (MCF) [ Time Frame: Up to 1 month ]
    Ultimate strength and stability of the fibrin clot measured by ROTEM.


Secondary Outcome Measures :
  1. clotting time CT [ Time Frame: Up to 1 month ]
    The time until initial fibrin formation measured by ROTEM

  2. clot formation time; CFT [ Time Frame: Up to 1 month ]
    The kinetics of fibrin formation and clot development measured by ROTEM

  3. D dimer [ Time Frame: Up to 1 month ]
    Indication of coagulation and fibrinolysis

  4. Platelet count [ Time Frame: Up to 1 month ]
    Ability of clot formation

  5. Prothrombin Time [ Time Frame: Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation ]
    measures of the extrinsic pathway of coagulation

  6. International Normalized Ratio (INR) [ Time Frame: Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation ]
    measures of the extrinsic pathway of coagulation

  7. sP-selectin [ Time Frame: Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation ]
    Acts as a receptor that supports binding of leukocytes to activated platelets and endothelium.

  8. Fibrinogen Level [ Time Frame: Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation ]
    A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation

  9. D-Dimer [ Time Frame: Pre-operative, after ligation of splenic artery, immediate post-operative, 24 hours and three days after operation ]
    A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient ASA physical status II and III.
  • Age between 22-55 years.
  • Child A suffering from pancytopenia.
  • Type of surgery: splenectomy

Exclusion Criteria:

  • Patients using oral anticoagulants
  • Patients using antithrombotic drugs
  • Patients using non steroidal anti-inflammatory drugs
  • Patients using oral contraceptives
  • Age less than 25 or more than 55 years
  • Obese patients (body mass index >35 kg m-2)
  • Pregnancy and lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079064


Locations
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Egypt
Theodor Bilharz Research Institute
Giza, Egypt, 12411
Sponsors and Collaborators
Theodor Bilharz Research Institute
Investigators
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Study Chair: Gehan G El-Fandy, M.D. Theodor Bilharz Research Institute

Additional Information:
Publications of Results:
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Responsible Party: Yasser Mostafa Samhan, Professor of Anesthesia, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier: NCT02079064     History of Changes
Other Study ID Numbers: Anesthesia 98T
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yasser Mostafa Samhan, Theodor Bilharz Research Institute:
Splenectomy
Desflurane
Propofol
TCI
ROTEM
Additional relevant MeSH terms:
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Propofol
Desflurane
Hemostatics
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Coagulants
Anesthetics, Inhalation