Postoperative ComplicationsNCT05027191
Effect of Desflurane Versus Sevoflurane With Recent Bio-markers on Renal and Hepatic Functions
An observational study of Postoperative Complications, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
Studying the effects of both inhalational anesthetics desflurane and sevoflurane on hepatic integrity and renal function, guided by recent blood and urine biomarkers in patients undergoing laparoscopic cholecystectomy surgery. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Neutrophil Gelatinase-Associated Lipocalin (NGAL), Desflurane and Sevoflurane
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2018to 1 Dec 2019
- Phase
- Observational
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: After informed written consents have been taken, this study will be conducted on 70 patients scheduled for laparoscopic cholecystectomy. The patients will be randomly allocated into two groups (a desflurane (D) group and a sevoflurane (S) group) using a sealed envelope technique for each group.
Who may be able to join
- American Society of Anesthesiologists (ASA) Class: I\&II.
- Elective laparoscopic cholecystectomy.
- Age: 25-55 years.
- Gender: Both male and female.
- Body Mass Index (BMI): 18.5-24.9 km2-(Normal weight).
Who cannot join
- Extremes of age.
- Abnormal hepatic function by alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values outside the normal range.
- Abnormal renal function by blood urea nitrogen (BUN) and creatinine above the normal ranges.
- Hypertension, unstable angina pectoris or myocardial infarction within the last six months.
- Pregnancy and lactation.
- Bronchial asthma.
Show all 9Show fewer
- Drug allergies.
- Alcohol or drug addiction.
- General anesthesia within the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of Desflurane Versus Sevoflurane With Recent Biomarkers of Renal and Hepatic Function in Laparoscopic Cholecystectomy Patients: A Prospective Randomized Double Blinded Study
Studying the effects of both inhalational anesthetics desflurane and sevoflurane on hepatic integrity and renal function, guided by recent blood and urine biomarkers in patients undergoing laparoscopic cholecystectomy surgery.
- Conditions
- Postoperative Complications
- Being tested
- Neutrophil Gelatinase-Associated Lipocalin (NGAL), Desflurane, Sevoflurane
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutrophil Gelatinase-Associated Lipocalin (NGAL)Diagnostic test
The evaluation of inhalational anesthetics (desflurane and sevoflurane) on NGAL levels in laparoscopic cholecystectomy patients.
DesfluraneDrug
Desflurane
SevofluraneDrug
Sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | This group will receive sevoflurane as the maintenance inhalational anesthetic. Receives: Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin (NGAL); Drug: Sevoflurane | |
| Desflurane | This group will receive desflurane as the maintenance inhalational anesthetic. Receives: Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin (NGAL); Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum Neutrophil gelatinase-associated lipocalin (NGAL)
Renal Biomarker
Measured: a change from baseline NGAL serum level at 6 hours
Secondary outcomes (6)
Change in serum Arginase
Hepatic biomarker
Measured: Baseline, first hour, six hours, after 24 hours
Change in serum Cystatin-c
Hepatic biomarker
Measured: Baseline, first hour, six hours, after 24 hours
Change in urine Netrin-1
Renal biomarker
Measured: Baseline, first hour, six hours, after 24 hours
Change in urine Kidney Injury Molecule
Renal biomarker
Measured: Baseline, first hour, six hours, after 24 hours
Change in urine Interleukin-18
cytokines
Measured: Baseline, first hour, six hours, after 24 hours
Change in urine Alpha-Glutathione S-Transferase
Liver biomarker
Measured: Baseline, first hour, six hours, after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start15 Feb 2018
- Primary completion20 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, khalda Galal Moustafa, Theodor Bilharz Research Institute
- Investigators
- Khalda G Radwan, MD, Principal investigator, Theodor Bilharz Rsearch Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027191
- Sponsor's protocol ID
- 110-T
- Status last verified
- Aug 2021
- First submitted
- 11 Sep 2019
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Desflurane Versus Sevoflurane With Recent Biomarkers of Renal and Hepatic Function in Laparoscopic Cholecystectomy Patients: A Prospective Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT05027191
- Acronym / sponsor ID
- 110-T
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 30 Aug 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.
Studying the effects of both inhalational anesthetics desflurane and sevoflurane on hepatic integrity and renal function, guided by recent blood and urine biomarkers in patients undergoing laparoscopic cholecystectomy surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | – | Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin (NGAL), Drug: SevofluraneThis group will receive sevoflurane as the maintenance inhalational anesthetic. |
| Desflurane | – | Diagnostic Test: Neutrophil Gelatinase-Associated Lipocalin (NGAL), Drug: DesfluraneThis group will receive desflurane as the maintenance inhalational anesthetic. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- After informed written consents have been taken, this study will be conducted on 70 patients scheduled for laparoscopic cholecystectomy. The patients will be randomly allocated into two groups (a desflurane (D) group and a sevoflurane (S) group) using a sealed envelope technique for each group.
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) Class: I\&II.
- Elective laparoscopic cholecystectomy.
- Age: 25-55 years.
- Gender: Both male and female.
- Body Mass Index (BMI): 18.5-24.9 km2-(Normal weight).
Key exclusion criteria (9 listed)
- Extremes of age.
- Abnormal hepatic function by alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values outside the normal range.
- Abnormal renal function by blood urea nitrogen (BUN) and creatinine above the normal ranges.
- Hypertension, unstable angina pectoris or myocardial infarction within the last six months.
- Pregnancy and lactation.
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 |
|---|---|---|
| Neutrophil Gelatinase-Associated Lipocalin (NGAL)The evaluation of inhalational anesthetics (desflurane and sevoflurane) on NGAL levels in laparoscopic cholecystectomy patients. | Diagnostic test | Desflurane, Sevoflurane |
| DesfluraneDesflurane | Drug | Desflurane |
| SevofluraneSevoflurane | Drug | Sevoflurane |
Primary outcome
Change in serum Neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: a change from baseline NGAL serum level at 6 hours
Renal Biomarker
6 secondary outcomes
Change in serum Arginase
Time frame: Baseline, first hour, six hours, after 24 hours
Change in serum Cystatin-c
Time frame: Baseline, first hour, six hours, after 24 hours
Change in urine Netrin-1
Time frame: Baseline, first hour, six hours, after 24 hours
Change in urine Kidney Injury Molecule
Time frame: Baseline, first hour, six hours, after 24 hours
Change in urine Interleukin-18
Time frame: Baseline, first hour, six hours, after 24 hours
Change in urine Alpha-Glutathione S-Transferase
Time frame: Baseline, first hour, six hours, after 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Khalda G Radwan, MD principal investigator
Theodor Bilharz Rsearch Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Theodor Bilharz Research Institute 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 30 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in serum Neutrophil gelatinase-associated lipocalin (NGAL) (time frame: a change from baseline NGAL serum level at 6 hours). 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 30 Aug 2021.