Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury

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 Overview

• Status: Recruiting
• Conditions: Hepatectomy
• Intervention / Treatment: Drug: Propofol, dexmedetomidine; Drug: Desflurane

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: ola Lashin, Master; Phone Number: 00201026034100; Email: Ola.lashin@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University
    • Contact: Ola Lashin, master; Phone Number: 00201026034100; Email: ola.lashin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Hany Alzahaby, Professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Dexmedetomidine; Desflurane
• Other Study ID Numbers: Ain Shams anesthesia Dep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: open source
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: open source
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• 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