Desflurane and Sevoflurane in Pediatrics With Elevated Liver Enzymes

NCT ID: NCT04775212

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-17

Study Completion Date

2021-10-17

Brief Summary

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

Detailed Description

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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).

Conditions

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Liver Functions Tests

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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desflurane

patients to be anesthetized with desflurane

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

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

sevoflurane

patients to be anesthetized with sevoflurane

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

Sevoflurane

Interventions

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Desflurane

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

Intervention Type DRUG

Sevoflurane

Sevoflurane

Intervention Type DRUG

Other Intervention Names

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Suprane

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Norma Osama Abdalla Zayed

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzan Adlan, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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National cancer institute

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP2101-50101

Identifier Type: -

Identifier Source: org_study_id

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