NCT05246371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2021

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 21, 2022

Last Update Submit

January 15, 2023

Conditions

Hepatectomy

Outcome Measures

Primary Outcomes (6)

  • aspartate aminotransferase (AST)

    aspartate aminotransferase (AST)

    1 week

  • alanine aminotransferase (ALT)

    alanine aminotransferase (ALT)

    1 week

  • bilirubin

    bilirubin

    1 week

  • albumin

    albumin

    1 week

  • prothrombin time

    prothrombin time

    1 week

  • INR

    INR

    1 week

Study Arms (2)

propofol and dexmedetomidine

EXPERIMENTAL

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

Drug: Propofol, dexmedetomidine

desflurane

EXPERIMENTAL

Patients will receive maintenance of general anesthesia by desflurane.

Drug: Desflurane

Interventions

Propofol, dexmedetomidineDRUG

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

Also known as: TIVA
propofol and dexmedetomidine
DesfluraneDRUG

Patients will receive maintenance of general anesthesia by desflurane.

Also known as: inhalational anesthesia
desflurane

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients American Society of Anesthesiologists physical status (ASA) I to II.
  • Patients Child Pugh classification A to B.
  • Both sexes.
  • Aged between 18 years and 70 years
  • Scheduled for more than 1 segment hepatectomy.

You may not qualify if:

  • Patients with Child Pugh classification C.
  • Patients younger than18 years old or older than 70 years old
  • Patients performed additional ablation therapies (cryosurgery or radiofrequency ablation).
  • Prior liver resection for donation.
  • Scheduled resection not requiring inflow occlusion (Pringle's maneuver).
  • Hypersensitivity to any of the used drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

PropofolDexmedetomidineDesflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Hany Alzahaby, Professor

    Ain Shams University

    STUDY CHAIR

Central Study Contacts

ola Lashin, Master

CONTACT

00201026034100Ola.lashin@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 18, 2022

Study Start

June 1, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

open source

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
2 years
Access Criteria
open source

Locations

EG(1)