Desflurane and Sevoflurane in Pediatrics With Elevated Liver Enzymes

Liver Functions Tests Clinical Trial

Official title:

Effects of Desflurane and Sevoflurane Anesthesia on Postoperative Liver Functions in Pediatric Cancer Patients With Elevated Liver Enzymes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04775212
• Other study ID #: AP2101-50101
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: October 17, 2021

Study information

• Verified date: October 2021
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: October 17, 2021
• Est. primary completion date: October 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Functions Tests

Intervention

Drug:
• Des?urane
compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions.
• Sevoflurane
Sevoflurane

Locations

Country	Name	City	State
Egypt	National cancer institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver function test	measuring Aspartate aminotransferase (AST)	6 months
Primary	ALT	measuring alanine aminotransferase (ALT)	6 months
Primary	Total bilirubin	measuring total bilirubin (TB)	6 months
Primary	prothrombin time	measuring prothrombin time (PT) expressed in international normalized ratio (INR)	6 months
Primary	Albumin	measuring level of albumin.	6 months