NCT04775212

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2021

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

February 25, 2021

Last Update Submit

October 2, 2021

Conditions

Liver Functions Tests

Keywords

Desflurane,Sevoflurane,liver enzymes,cancer

Outcome Measures

Primary Outcomes (5)

  • liver function test

    measuring Aspartate aminotransferase (AST)

    6 months

  • ALT

    measuring alanine aminotransferase (ALT)

    6 months

  • Total bilirubin

    measuring total bilirubin (TB)

    6 months

  • prothrombin time

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

    6 months

  • Albumin

    measuring level of albumin.

    6 months

Study Arms (2)

desflurane

ACTIVE COMPARATOR

patients to be anesthetized with desflurane

Drug: Desflurane

sevoflurane

ACTIVE COMPARATOR

patients to be anesthetized with sevoflurane

Drug: Sevoflurane

Interventions

DesfluraneDRUG

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

Also known as: Suprane
desflurane
SevofluraneDRUG

Sevoflurane

sevoflurane

Eligibility Criteria

Age1 Year - 12 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details2-18 years old
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age \>1 year and \< 12 years old.
  • Estimated time of surgeries within 1-3 hours.
  • Elevated liver enzymes less than triple folds.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National cancer institute

Cairo, 11769, Egypt

Location

MeSH Terms

Interventions

DesfluraneSevoflurane

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Suzan Adlan, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

June 17, 2021

Primary Completion

October 17, 2021

Study Completion

October 17, 2021

Last Updated

October 5, 2021

Record last verified: 2021-10

Locations

EG(1)