Pituitary AdenomaNCT02709863
Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests
A study testing Sevoflurane, Desflurane and Propofol in people with Pituitary Adenoma, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study will compare the effects of sevoflurane, desflurane and total intravenous anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal transsphenoidal surgery of pituitary gland. Participants will be divided into three equal groups. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Sevoflurane, Desflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2015to Feb 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) score I-II patients
Who cannot join
- Significant cardiopulmonary disease,
- Diagnosed obstructive or restrictive pulmonary disease,
- Patients with chest wall deformities, liver or kidney failure,
- Postoperative lack of cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department
Istanbul, 34098
Özlem Korkmaz Dilmen, Assoc. Prof., 00905325801520, korkmazdilmen@gmail.com
Eren F Akcıl, M.D.
About this study
Official title: Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests in Patients Undergoing Endoscopic Endonasal Transsphenoidal Surgery of Pituitary Gland
This study will compare the effects of sevoflurane, desflurane and total intravenous anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal transsphenoidal surgery of pituitary gland. Participants will be divided into three equal groups. The first group will receive sevoflurane, second grup will receive desflurane and third grup will receive total intravenous anaesthesia. Investigators are also going to evaluate blood gas analysis.
Read the detailed description
Investigators are going to evaluate forced expiratory volume in 1st Second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, partial pressure of arterial oxygen (PaO2), partial pressure of arterial carbon dioxide (PaCO2), potential of hydrogen (pH), arterial oxygen saturation (SaO2), base excess (BE), bicarbonate (HCO3) and partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio to compare the effects of drugs.
- Conditions
- Pituitary Adenoma
- Being tested
- Sevoflurane, Desflurane, Propofol
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
1-1.5 MAC, inhalation route, during operation
DesfluraneDrug
Also called Suprane
1-1.5 MAC, inhalation route, during operation
PropofolDrug
6-10 mg/kg/h, iv infusion, during operation
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | 1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation Receives: Drug: Sevoflurane |
| Desflurane | Active comparator | 1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation Receives: Drug: Desflurane |
| Propofol | Active comparator | 6-10 mg/kg/h, iv infusion, during operation Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline FEV1%predicted (no unit)
FEV1 is measured with spirolab III colour liquid-crystal-display medical spirometer. FEV1%predicted is calculated with age, sex, height and weight input by the same equipment.
Measured: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
Secondary outcomes (9)
Change from baseline FVC%predicted (no unit)
FVC is measured with spirolab III colour liquid-crystal-display medical spirometer. FVC%predicted is calculated with age, sex, height and weight input by the same equipment.
Measured: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
Change from baseline FEV1/FVC ratio (no units)
FEV1/FVC ratio is calculated by spirolab III colour liquid-crystal-display medical spirometer based on age, sex, height and weight.
Measured: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
Change from baseline PaO2 (mmHg)
PaO2 is a component of arterial blood gas analysis done with Cobas B221.
Measured: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline PaCO2 (mmHg)
PaCO2 is a component of arterial blood gas analysis done with Cobas B221.
Measured: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline pH
pH is a component of arterial blood gas analysis done with Cobas B221
Measured: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline SaO2 (%)
SaO2 is a component of arterial blood gas analysis done with Cobas B221
Measured: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline BE (mmol/L)
BE is a component of arterial blood gas analysis done with Cobas B221
Measured: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline HCO3 (mmol/L)
HCO3 is a component of arterial blood gas analysis done with Cobas B221
Measured: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline PaO2/FiO2 ratio (no units)
PaO2/FiO2 ratio is calculated by investigators
Measured: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulvahap Oguz, Istanbul University
- Investigators
- Özlem Korkmaz Dilmen, Assoc. Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709863
- Sponsor's protocol ID
- 83045809/604.01/02
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2016
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests in Patients Undergoing Endoscopic Endonasal Transsphenoidal Surgery of Pituitary Gland
- ClinicalTrials.gov ID
- NCT02709863
- Acronym / sponsor ID
- 83045809/604.01/02
- Conditions
- Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 16 Mar 2016 (estimated)
- 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.
This study will compare the effects of sevoflurane, desflurane and total intravenous anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal transsphenoidal surgery of pituitary gland. Participants will be divided into three equal groups. The first group will receive sevoflurane, second grup will receive desflurane and third grup will receive total intravenous anaesthesia. Investigators are also going to evaluate blood gas analysis.
Detailed description
Investigators are going to evaluate forced expiratory volume in 1st Second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, partial pressure of arterial oxygen (PaO2), partial pressure of arterial carbon dioxide (PaCO2), potential of hydrogen (pH), arterial oxygen saturation (SaO2), base excess (BE), bicarbonate (HCO3) and partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio to compare the effects of drugs.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: Sevoflurane1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation |
| Desflurane | Active comparator | Drug: Desflurane1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation |
| Propofol | Active comparator | Drug: Propofol6-10 mg/kg/h, iv infusion, during operation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) score I-II patients
Key exclusion criteria (4 listed)
- Significant cardiopulmonary disease,
- Diagnosed obstructive or restrictive pulmonary disease,
- Patients with chest wall deformities, liver or kidney failure,
- Postoperative lack of cooperation
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 |
|---|---|---|
| SevofluraneAlso: Sevorane1-1.5 MAC, inhalation route, during operation | Drug | Sevoflurane |
| DesfluraneAlso: Suprane1-1.5 MAC, inhalation route, during operation | Drug | Desflurane |
| Propofol6-10 mg/kg/h, iv infusion, during operation | Drug | Propofol |
Primary outcome
Change from baseline FEV1%predicted (no unit)
Time frame: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
FEV1 is measured with spirolab III colour liquid-crystal-display medical spirometer. FEV1%predicted is calculated with age, sex, height and weight input by the same equipment.
9 secondary outcomes
Change from baseline FVC%predicted (no unit)
Time frame: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
Change from baseline FEV1/FVC ratio (no units)
Time frame: Preoperative baseline, postoperative 1st hour and postoperative 24th hour
Change from baseline PaO2 (mmHg)
Time frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline PaCO2 (mmHg)
Time frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline pH
Time frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline SaO2 (%)
Time frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline BE (mmol/L)
Time frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline HCO3 (mmol/L)
Time frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Change from baseline PaO2/FiO2 ratio (no units)
Time frame: Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Pituitary Adenoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
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.
Özlem Korkmaz Dilmen, Assoc. Prof. study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane, Desflurane and Propofol in people with Pituitary Adenoma, run by Istanbul University 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 1 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 16 Mar 2016. 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.
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?
Contact Abdulvahap Oguz, MD (00905444461924, avahapoguz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline FEV1%predicted (no unit) (time frame: Preoperative baseline, postoperative 1st hour and postoperative 24th hour). 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 16 Mar 2016.