Clinical trial NCT04775212: Desflurane and Sevoflurane in Pediatrics With Elevated Liver Enzymes
Official title: Effects of Desflurane and Sevoflurane Anesthesia on Postoperative Liver Functions in Pediatric Cancer Patients With Elevated Liver Enzymes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Functions Tests
Keywords: Desflurane,Sevoflurane,liver enzymes,cancer
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: liver function test
timeFrame: 6 months
measure: ALT
timeFrame: 6 months
measure: Total bilirubin
timeFrame: 6 months
measure: prothrombin time
timeFrame: 6 months
measure: Albumin
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National cancer institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Suzan Adlan, MD
role: PRINCIPAL_INVESTIGATOR
References: