Desflurane and Sevoflurane in Pediatrics With Elevated Liver Enzymes

Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04775212
Collaborator
(none)
60
1
2
4
15

Study Details

Study Description

Brief Summary

It is designed to compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions in pediatric cancer patients

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Patients will be randomly allocated into two groups using a sealed envelope technique:

desflurane group (Des group, n = 30) and sevoflurane group (sevo group, n = 30).

Anesthesia monitoring included electrocardiogram, continuous arterial and pulse oximetry, capnography, urine output, nerve stimulator, and esophageal core temperature.

Anesthesia will be induced with Propofol 2 mg/kg ,FentanyL 2 μg/kg and atracurium (0.5 mg/kg) was administered to achieve muscle relaxation before endotracheal intubation. End-tidal desflurane or sevoflurane concentrations during the induction were limited to 2 minimal alveolar concentration (MAC). Concentrations of inhalational anesthetics were measured using an anesthetic gas analyser (Datex-Ohmeda, Helsinki, Finland). For the maintenance of anesthesia, the inspired desflurane or sevoflurane concentration was carefully titrated to maintain the end-tidal concentration of 1 MAC. A constant fresh gas flow of 3 l/min (medical-grade air in oxygen to make inspiratory oxygen fraction 0.5) was used during the maintenance of anesthesia. Ventilation was controlled with a tidal volume of 7-10 ml/kg and ventilatory rate was adjusted to maintain an end tidal carbon dioxide ( CO2 )of 35-40 mmHg. to maintain intraoperative blood pressure (BP) and heart rate (HR) within 20% of preoperative values. additional Atracurium will be administered as appropriate. Nerve stimulator was used to monitor neuromuscular blockade on the right adductor pollicis. Hypotension (a drop in systolic BP to the extent of 30% or more or the systolic BP being less than the preoperative values) was treated with volume replacement and, when necessary, with intravenous ephedrine in incremental doses .Bradycardia (HR < 50 beats per min) was treated with atropine if needed.

Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) expressed in international normalized ratio (INR), albumin, platelet count (PLT), and hemoglobin (Hb) were analysed at preoperative period, immediately after operation, and on the 1st, 2nd, 3rd, 5th and 7th, postoperative days (PODs).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Desflurane and Sevoflurane Anesthesia on Postoperative Liver Functions in Pediatric Cancer Patients With Elevated Liver Enzymes
Actual Study Start Date :
Jun 17, 2021
Anticipated Primary Completion Date :
Oct 17, 2021
Anticipated Study Completion Date :
Oct 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: desflurane

patients to be anesthetized with desflurane

Drug: Desflurane
compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions.
Other Names:
  • Suprane
  • Active Comparator: sevoflurane

    patients to be anesthetized with sevoflurane

    Drug: Sevoflurane
    Sevoflurane

    Outcome Measures

    Primary Outcome Measures

    1. liver function test [6 months]

      measuring Aspartate aminotransferase (AST)

    2. ALT [6 months]

      measuring alanine aminotransferase (ALT)

    3. Total bilirubin [6 months]

      measuring total bilirubin (TB)

    4. prothrombin time [6 months]

      measuring prothrombin time (PT) expressed in international normalized ratio (INR)

    5. Albumin [6 months]

      measuring level of albumin.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age >1 year and < 12 years old.

    • Estimated time of surgeries within 1-3 hours.

    • Elevated liver enzymes less than triple folds.

    Exclusion Criteria:
    • Patient refusal.

    • Hepatitis positive patients.

    • Raising liver enzymes.

    • Hepatic surgeries.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National cancer institute Cairo Egypt 11769

    Sponsors and Collaborators

    • National Cancer Institute, Egypt

    Investigators

    • Principal Investigator: Suzan Adlan, MD, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norma Osama Abdalla Zayed, assistant lecturer, National Cancer Institute, Egypt
    ClinicalTrials.gov Identifier:
    NCT04775212
    Other Study ID Numbers:
    • AP2101-50101
    First Posted:
    Mar 1, 2021
    Last Update Posted:
    Oct 5, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norma Osama Abdalla Zayed, assistant lecturer, National Cancer Institute, Egypt
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2021