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Status unknownNCT04775212Updated Oct 5, 2021

Desflurane and Sevoflurane in Pediatrics With Elevated Liver Enzymes

An interventional study of Desflurane and Sevoflurane in Liver Functions Tests, sponsored by National Cancer Institute, Egypt. Status unknown at 1 site in Egypt. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2021-10-05.

Sponsored by National Cancer Institute, Egypt · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Year to 12 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Liver Functions Tests

Keywords

  • Desflurane,Sevoflurane,liver enzymes,cancer
03

In context

Lead sponsor

National Cancer Institute, Egypt is the lead sponsor of 133 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
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

Exclusion Criteria:

  • Patient refusal.
  • Hepatitis positive patients.
  • Raising liver enzymes.
  • Hepatic surgeries.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    desflurane

    patients to be anesthetized with desflurane

    Drug: Desflurane

  • Active comparator
    sevoflurane

    patients to be anesthetized with sevoflurane

    Drug: Sevoflurane

Interventions

  • DrugDesflurane

    compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions.

    Also known as: Suprane

  • DrugSevoflurane

    Sevoflurane

06

What researchers measure

Primary outcomes

  1. liver function test

    measuring Aspartate aminotransferase (AST)

    Time frame: 6 months

  2. ALT

    measuring alanine aminotransferase (ALT)

    Time frame: 6 months

  3. Total bilirubin

    measuring total bilirubin (TB)

    Time frame: 6 months

  4. prothrombin time

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

    Time frame: 6 months

  5. Albumin

    measuring level of albumin.

    Time frame: 6 months

07

Study locations

1 site
  • National cancer institute
    Cairo, 11769, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04775212
Lead sponsor
National Cancer Institute, Egypt
Responsible party
Norma Osama Abdalla Zayed (assistant lecturer, National Cancer Institute, Egypt) — Principal investigator
First posted
Mar 1, 2021
Start date
Jun 17, 2021
Primary completion
Oct 17, 2021 (estimated)
Completion
Oct 17, 2021 (estimated)
Last update
Oct 5, 2021

Study contacts

Suzan Adlan, MD
principal investigator · National Cancer Institute (NCI)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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