Liver Functions TestsNCT04775212
Desflurane and Sevoflurane in Pediatrics With Elevated Liver Enzymes
A study testing Desflurane and Sevoflurane in people with Liver Functions Tests, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
It is designed to compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions in pediatric cancer patients Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Liver Functions Tests
- What is being tested?
- Desflurane and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jun 2021to 17 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age >1 year and < 12 years old.
- Estimated time of surgeries within 1-3 hours.
- Elevated liver enzymes less than triple folds.
Who cannot join
- Patient refusal.
- Hepatitis positive patients.
- Raising liver enzymes.
- Hepatic surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Desflurane and Sevoflurane Anesthesia on Postoperative Liver Functions in Pediatric Cancer Patients With Elevated Liver Enzymes
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).
- Conditions
- Liver Functions Tests
- Being tested
- Desflurane, Sevoflurane
- Keywords
- Desflurane,Sevoflurane,liver enzymes,cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called Suprane
compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions.
SevofluraneDrug
Sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| desflurane | Active comparator | patients to be anesthetized with desflurane Receives: Drug: Desflurane |
| sevoflurane | Active comparator | patients to be anesthetized with sevoflurane Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
liver function test
measuring Aspartate aminotransferase (AST)
Measured: 6 months
ALT
measuring alanine aminotransferase (ALT)
Measured: 6 months
Total bilirubin
measuring total bilirubin (TB)
Measured: 6 months
prothrombin time
measuring prothrombin time (PT) expressed in international normalized ratio (INR)
Measured: 6 months
Albumin
measuring level of albumin.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start17 Jun 2021
- Primary completion17 Oct 2021 (estimated)
- Study completion17 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Functions TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norma Osama Abdalla Zayed, National Cancer Institute, Egypt
- Investigators
- Suzan Adlan, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775212
- Sponsor's protocol ID
- AP2101-50101
- Status last verified
- Oct 2021
- First submitted
- 25 Feb 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Desflurane and Sevoflurane Anesthesia on Postoperative Liver Functions in Pediatric Cancer Patients With Elevated Liver Enzymes
- ClinicalTrials.gov ID
- NCT04775212
- Acronym / sponsor ID
- AP2101-50101
- Conditions
- Liver Functions Tests
- Keywords
- Desflurane,Sevoflurane,liver enzymes,cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 17 Oct 2021 (estimated)
- Study completion
- 17 Oct 2021 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| desflurane | Active comparator | Drug: Desfluranepatients to be anesthetized with desflurane |
| sevoflurane | Active comparator | Drug: Sevofluranepatients to be anesthetized with sevoflurane |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age >1 year and < 12 years old.
- Estimated time of surgeries within 1-3 hours.
- Elevated liver enzymes less than triple folds.
Key exclusion criteria (4 listed)
- Patient refusal.
- Hepatitis positive patients.
- Raising liver enzymes.
- Hepatic surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneAlso: Supranecompare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions. | Drug | desflurane |
| SevofluraneSevoflurane | Drug | sevoflurane |
Primary outcome
liver function test
Time frame: 6 months
measuring Aspartate aminotransferase (AST)
ALT
Time frame: 6 months
measuring alanine aminotransferase (ALT)
Total bilirubin
Time frame: 6 months
measuring total bilirubin (TB)
prothrombin time
Time frame: 6 months
measuring prothrombin time (PT) expressed in international normalized ratio (INR)
Albumin
Time frame: 6 months
measuring level of albumin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzan Adlan, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane and Sevoflurane in people with Liver Functions Tests, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
liver function test (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.