Cholecystitis, ChronicPhase 4NCT06457958
Effect of Sevoflurane and Desflurane on Heme Oxygenase-1 Expression in Elective Cholecystectomy
A Phase 4 study testing Sevoflurane Group and Desflurane Group in people with Cholecystitis, Chronic, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
General anesthesia is routinely administered to patients who undergo elective cholecystectomy. The most commonly used inhalation agents during general anesthesia are sevoflurane and desflurane. Participants who will undergo elective cholecystectomy surgery and meet the eligibility criteria will be randomized. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholecystitis, Chronic
- What is being tested?
- Sevoflurane Group and Desflurane Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing participants
- ASA class 1-2-3
- Ages 18-65 years
- Patients undergoing elective cholecystectomy surgery
Who cannot join
- Patients undergoing emergency cholecystectomy surgery
- Pregnant and postpartum patients
- Patients with a history of oncological diseases
- Patients with known genetic diseases
- Patients receiving total intravenous anesthesia
- Patients developing complications during surgery will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sevoflurane and Desflurane Anesthetic Agents Used in Elective Cholecystectomy Surgery on Heme Oxygenase-1 mRNA Expression and Heme Oxygenase-1 Protein Levels: A Comparative Prospective Study
General anesthesia is routinely administered to patients who undergo elective cholecystectomy. The most commonly used inhalation agents during general anesthesia are sevoflurane and desflurane. Participants who will undergo elective cholecystectomy surgery and meet the eligibility criteria will be randomized. Participants will be divided into two groups. One group will receive sevoflurane, and the other group will receive desflurane. Preoperative and postoperative blood samples will be taken from the participants. After the sample collection process is completed, the ELISA method will be used for measuring blood heme oxygenase-1 protein levels, and the PCR technique will be used for measuring blood heme oxygenase-1 mRNA gene expression. The increase in amounts between the two groups will be compared. This study aims to demonstrate the effects of the most commonly used inhalation agents on the levels of heme oxygenase-1 enzyme, which has been shown to be an important enzyme in cellular protection mechanisms, as well as on mRNA gene expression, and to determine which agent may be more effective in preventing cellular damage at the molecular level.
Read the detailed description
In this study, the aim is to compare the effects of two commonly used inhalation agents, sevoflurane and desflurane, on heme oxygenase-1 (HO-1) enzyme levels. The total amounts of sevoflurane and desflurane administered to patients, as well as their overall oxygen consumption, will also be monitored. This data will allow for the exploration of how these inhalation agents and oxygen intake influence HO-1 enzyme levels, both across and within groups. The goal is to determine which agent demonstrates more effective cellular protection at the molecular level. This study will scientifically investigate how these commonly used agents impact HO-1 enzyme levels and gene expression, drawing conclusions based on the data obtained. The findings are anticipated to provide valuable insights for future clinical research and expand horizons in this field.
Study Design and Power Analysis:
The study follows a comparative prospective parallel-group design and is classified as low-risk scientific research. Sample size determination was based on a power analysis using G*Power 3.1 software. A t-test will be employed for comparison between two independent groups, with an alpha error probability set at 0.05 and a power (1-beta error probability) of 0.90. A total of 48 patients, with 24 in each group, will be included.
Inclusion Criteria:
Willing participants ASA class 1-2-3 Ages 18-65 Patients undergoing elective cholecystectomy surgery
Exclusion Criteria:
Patients undergoing emergency cholecystectomy surgery Pregnant and postpartum patients Patients with a history of oncological diseases Patients with known genetic diseases Patients receiving total intravenous anesthesia Patients developing complications during surgery
Study Procedures:
Preoperative blood samples will be obtained from enrolled patients 1 hour before surgery. Patients undergoing general anesthesia will be randomly assigned to receive either sevoflurane or desflurane inhalation agent. Standard anesthesia procedures will be followed. Total amounts of sevoflurane/desflurane consumed, oxygen consumption, and vital parameters will be recorded throughout the procedure. Postoperative blood samples will be collected 1 hour after extubation. Patient follow-up will then conclude. Blood samples will be stored in the hospital's biochemistry laboratory. HO-1 blood protein levels will be measured using the ELISA method, and HO-1 mRNA expression will be assessed using PCR. This study aims to determine which inhalation agent offers superior cellular protection at the molecular level by assessing their effects on HO-1 enzyme levels and gene expression.
- Conditions
- Cholecystitis, Chronic
- Being tested
- Sevoflurane Group, Desflurane Group
- Keywords
- Anesthetics, Inhalation, Heme Oxygenase-1, Oxidative Stress, Sevoflurane, Desflurane, Anesthesia, General, Cholecystectomy
- Medical subject headings
- Cholecystitis, Bronchiolitis Obliterans Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane GroupDrug
Also called Sevoflurane maintenance anesthesia group
Preoperative: One hour before surgery, a blood sample will be taken. Intraoperative: Sevoflurane will be used as the inhalational anesthetic. Routine general anesthesia procedures will be followed. Sevoflurane consumption, oxygen levels, and vital parameters will be recorded.
Postoperative: One hour after extubation, another blood sample will be taken, marking the end of patient monitoring.
Laboratory Analysis: Blood samples will be stored in the biochemistry laboratory. Hemoxygenase-1 protein levels will be measured by ELISA, and mRNA expression will be analyzed using PCR.
Desflurane GroupDrug
Also called Desflurane maintenance anesthesia group
Preoperative: One hour before surgery, a blood sample will be taken. Intraoperative: Desflurane will be used as the inhalational anesthetic. Routine general anesthesia procedures will be followed. Desflurane consumption, oxygen levels, and vital parameters will be recorded.
Postoperative: One hour after extubation, another blood sample will be taken, marking the end of patient monitoring.
Laboratory Analysis: Blood samples will be stored in the biochemistry laboratory. Hemoxygenase-1 protein levels will be measured by ELISA, and mRNA expression will be analyzed using PCR.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Active comparator | Patients in this group will receive sevoflurane as the anesthetic agent during elective cholecystectomy surgery.
Sevoflurane is a commonly used inhalational anesthetic known for its rapid onset and recovery times. Receives: Drug: Sevoflurane Group |
| Desflurane Group | Active comparator | Patients in this group will receive desflurane as the anesthetic agent during elective cholecystectomy surgery.
Desflurane is another widely used inhalational anesthetic, notable for its low blood-gas solubility coefficient, leading to very rapid onset and recovery times. Receives: Drug: Desflurane Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Effects of Sevoflurane and Desflurane Inhalation Anesthetics on Blood Heme Oxygenase-1 Gene and Protein Levels
The aim of this study is to compare the effects of sevoflurane and desflurane, commonly used inhalation anesthetics in routine anesthesia practice, on blood heme oxygenase-1 gene and protein levels.
Measured: Postoperative at hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jun 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Terminated due to lack of financial support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, ChronicStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 2 parallel study arms where sevoflurane and desflurane are administered.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- BEDİRHAN GÜNEL, MD, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457958
- Sponsor's protocol ID
- KSH-ANREA-BG-01
- Status last verified
- Aug 2024
- First submitted
- 1 Jun 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request can be made to obtain patient data from the institution. Data will not be shared by the researchers.
Publications
Bauer I, Raupach A. The Role of Heme Oxygenase-1 in Remote Ischemic and Anesthetic Organ Conditioning. Antioxidants (Basel). 2019 Sep 16;8(9):403. doi: 10.3390/antiox8090403.
PubMed 31527528Wu ZF, Lin WL, Lee MS, Hung NK, Huang YS, Chen TW, Lu CH. Propofol vs desflurane on the cytokine, matrix metalloproteinase-9, and heme oxygenase-1 response during living donor liver transplantation: A pilot study. Medicine (Baltimore). 2019 Nov;98(48):e18244. doi: 10.1097/MD.0000000000018244.
PubMed 31770287Hoetzel A, Schmidt R. Regulatory role of anesthetics on heme oxygenase-1. Curr Drug Targets. 2010 Dec;11(12):1495-503. doi: 10.2174/1389450111009011495.
PubMed 20704551
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sevoflurane and Desflurane Anesthetic Agents Used in Elective Cholecystectomy Surgery on Heme Oxygenase-1 mRNA Expression and Heme Oxygenase-1 Protein Levels: A Comparative Prospective Study
- ClinicalTrials.gov ID
- NCT06457958
- Acronym / sponsor ID
- KSH-ANREA-BG-01
- Conditions
- Cholecystitis, Chronic
- Keywords
- Anesthetics, Inhalation, Heme Oxygenase-1, Oxidative Stress, Sevoflurane, Desflurane, Anesthesia, General, Cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to lack of financial support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
General anesthesia is routinely administered to patients who undergo elective cholecystectomy. The most commonly used inhalation agents during general anesthesia are sevoflurane and desflurane. Participants who will undergo elective cholecystectomy surgery and meet the eligibility criteria will be randomized. Participants will be divided into two groups. One group will receive sevoflurane, and the other group will receive desflurane. Preoperative and postoperative blood samples will be taken from the participants. After the sample collection process is completed, the ELISA method will be used for measuring blood heme oxygenase-1 protein levels, and the PCR technique will be used for measuring blood heme oxygenase-1 mRNA gene expression. The increase in amounts between the two groups will be compared. This study aims to demonstrate the effects of the most commonly used inhalation agents on the levels of heme oxygenase-1 enzyme, which has been shown to be an important enzyme in cellular protection mechanisms, as well as on mRNA gene expression, and to determine which agent may be more effective in preventing cellular damage at the molecular level.
Detailed description
In this study, the aim is to compare the effects of two commonly used inhalation agents, sevoflurane and desflurane, on heme oxygenase-1 (HO-1) enzyme levels. The total amounts of sevoflurane and desflurane administered to patients, as well as their overall oxygen consumption, will also be monitored. This data will allow for the exploration of how these inhalation agents and oxygen intake influence HO-1 enzyme levels, both across and within groups. The goal is to determine which agent demonstrates more effective cellular protection at the molecular level. This study will scientifically investigate how these commonly used agents impact HO-1 enzyme levels and gene expression, drawing conclusions based on the data obtained. The findings are anticipated to provide valuable insights for future clinical research and expand horizons in this field.
Study Design and Power Analysis:
The study follows a comparative prospective parallel-group design and is classified as low-risk scientific research. Sample size determination was based on a power analysis using G*Power 3.1 software. A t-test will be employed for comparison between two independent groups, with an alpha error probability set at 0.05 and a power (1-beta error probability) of 0.90. A total of 48 patients, with 24 in each group, will be included.
Inclusion Criteria:
Willing participants ASA class 1-2-3 Ages 18-65 Patients undergoing elective cholecystectomy surgery
Exclusion Criteria:
Patients undergoing emergency cholecystectomy surgery Pregnant and postpartum patients Patients with a history of oncological diseases Patients with known genetic diseases Patients receiving total intravenous anesthesia Patients developing complications during surgery
Study Procedures:
Preoperative blood samples will be obtained from enrolled patients 1 hour before surgery. Patients undergoing general anesthesia will be randomly assigned to receive either sevoflurane or desflurane inhalation agent. Standard anesthesia procedures will be followed. Total amounts of sevoflurane/desflurane consumed, oxygen consumption, and vital parameters will be recorded throughout the procedure. Postoperative blood samples will be collected 1 hour after extubation. Patient follow-up will then conclude. Blood samples will be stored in the hospital's biochemistry laboratory. HO-1 blood protein levels will be measured using the ELISA method, and HO-1 mRNA expression will be assessed using PCR. This study aims to determine which inhalation agent offers superior cellular protection at the molecular level by assessing their effects on HO-1 enzyme levels and gene expression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There will be 2 parallel study arms where sevoflurane and desflurane are administered.
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | Active comparator | Drug: Sevoflurane GroupPatients in this group will receive sevoflurane as the anesthetic agent during elective cholecystectomy surgery. Sevoflurane is a commonly used inhalational anesthetic known for its rapid onset and recovery times. |
| Desflurane Group | Active comparator | Drug: Desflurane GroupPatients in this group will receive desflurane as the anesthetic agent during elective cholecystectomy surgery. Desflurane is another widely used inhalational anesthetic, notable for its low blood-gas solubility coefficient, leading to very rapid onset and recovery times. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing participants
- ASA class 1-2-3
- Ages 18-65 years
- Patients undergoing elective cholecystectomy surgery
Key exclusion criteria (6 listed)
- Patients undergoing emergency cholecystectomy surgery
- Pregnant and postpartum patients
- Patients with a history of oncological diseases
- Patients with known genetic diseases
- Patients receiving total intravenous anesthesia
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 |
|---|---|---|
| Sevoflurane GroupAlso: Sevoflurane maintenance anesthesia groupPreoperative: One hour before surgery, a blood sample will be taken. Intraoperative: Sevoflurane will be used as the inhalational anesthetic. Routine general anesthesia procedures will be followed. Sevoflurane consumption, oxygen levels, and vital parameters will be recorded. Postoperative: One hour after extubation, another blood sample will be taken, marking the end of patient monitoring. Laboratory Analysis: Blood samples will be stored in the biochemistry laboratory. Hemoxygenase-1 protein levels will be measured by ELISA, and mRNA expression will be analyzed using PCR. | Drug | Sevoflurane Group |
| Desflurane GroupAlso: Desflurane maintenance anesthesia groupPreoperative: One hour before surgery, a blood sample will be taken. Intraoperative: Desflurane will be used as the inhalational anesthetic. Routine general anesthesia procedures will be followed. Desflurane consumption, oxygen levels, and vital parameters will be recorded. Postoperative: One hour after extubation, another blood sample will be taken, marking the end of patient monitoring. Laboratory Analysis: Blood samples will be stored in the biochemistry laboratory. Hemoxygenase-1 protein levels will be measured by ELISA, and mRNA expression will be analyzed using PCR. | Drug | Desflurane Group |
Primary outcome
Comparison of the Effects of Sevoflurane and Desflurane Inhalation Anesthetics on Blood Heme Oxygenase-1 Gene and Protein Levels
Time frame: Postoperative at hour 1
The aim of this study is to compare the effects of sevoflurane and desflurane, commonly used inhalation anesthetics in routine anesthesia practice, on blood heme oxygenase-1 gene and protein levels.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 31527528Bauer I, Raupach A. The Role of Heme Oxygenase-1 in Remote Ischemic and Anesthetic Organ Conditioning. Antioxidants (Basel). 2019 Sep 16;8(9):403. doi: 10.3390/antiox8090403.
- Background: PubMed 31770287Wu ZF, Lin WL, Lee MS, Hung NK, Huang YS, Chen TW, Lu CH. Propofol vs desflurane on the cytokine, matrix metalloproteinase-9, and heme oxygenase-1 response during living donor liver transplantation: A pilot study. Medicine (Baltimore). 2019 Nov;98(48):e18244. doi: 10.1097/MD.0000000000018244.
- Background: PubMed 20704551Hoetzel A, Schmidt R. Regulatory role of anesthetics on heme oxygenase-1. Curr Drug Targets. 2010 Dec;11(12):1495-503. doi: 10.2174/1389450111009011495.
- Individual participant dataSharing planned: No. Upon reasonable request can be made to obtain patient data from the institution. Data will not be shared by the researchers.
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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.
BEDİRHAN GÜNEL, MD principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane Group and Desflurane Group in people with Cholecystitis, Chronic, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Feb 2025. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Comparison of the Effects of Sevoflurane and Desflurane Inhalation Anesthetics on Blood Heme Oxygenase-1 Gene and Protein Levels (time frame: Postoperative at hour 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06457958, which also lists 3 linked publications.
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 Feb 2025.