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Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05246371
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Postoperative impairment of liver function is common after hepatectomy. It may be caused by surgical trauma, loss of hepatic mass, stress response, hepatic oxygen deprivation, infection and drug toxicity.

Anesthetic agents used in general anesthesia for liver surgery have a big effect on hepatic blood flow, oxygen delivery and liver function This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: propofol and dexmedetomidine

Patients will receive maintenance of general anesthesia by TIVA using combination of propofol and dexmedetomidine

Drug: Propofol, dexmedetomidine
Patients will receive maintenance of general anesthesia by TIVA using combination of propofol and dexmedetomidine.
Other Names:
  • TIVA

    		•
    Experimental: desflurane

    Patients will receive maintenance of general anesthesia by desflurane.

    Drug: Desflurane
    Patients will receive maintenance of general anesthesia by desflurane.
    Other Names:
  • inhalational anesthesia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. aspartate aminotransferase (AST) [1 week]

      aspartate aminotransferase (AST)

    2. alanine aminotransferase (ALT) [1 week]

      alanine aminotransferase (ALT)

    3. bilirubin [1 week]

      bilirubin

    4. albumin [1 week]

      albumin

    5. prothrombin time [1 week]

      prothrombin time

    6. INR [1 week]

      INR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients American Society of Anesthesiologists physical status (ASA) I to II.

    2. Patients Child Pugh classification A to B.

    3. Both sexes.

    4. Aged between 18 years and 70 years

    5. Scheduled for more than 1 segment hepatectomy.

    Exclusion Criteria:

    1. Patients with Child Pugh classification C.

    2. Patients younger than18 years old or older than 70 years old

    3. Patients performed additional ablation therapies (cryosurgery or radiofrequency ablation).

    4. Prior liver resection for donation.

    5. Scheduled resection not requiring inflow occlusion (Pringle's maneuver).

    6. Hypersensitivity to any of the used drugs.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Cairo Egypt 11835

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Ola ahmed, master, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05246371
    Other Study ID Numbers:
    • Ain Shams anesthesia Dep
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Dexmedetomidine
    Propofol
    Desflurane

    Study Results

    No Results Posted as of Feb 18, 2022