AnesthesiaNCT03399201
The Effect of Anesthesia Type on Pulmonary Function
A study testing General anesthesia, Neuraxial anesthesia and Spirometer in people with Anesthesia and Geriatric Patients, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The role of neuraxial anesthesia in preventing respiratory complications is a controversial in elderly patients. The aim of the study was to evaluate the benefits of neuraxial anesthesia on pulmonary function during post-operative term in geriatric patients undergoing to elective non-abdominal surgery. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Anesthesia, Geriatric Patients
- What is being tested?
- General anesthesia, Neuraxial anesthesia and Spirometer
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2018to 2 Dec 2018
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years of age
- Undergoing non-abdominal surgery under anesthesia in supine position
Who cannot join
- Pulmonary disease
- Hematological disease
- Undergoing Abdominal surgery
- Non-supine position during surgery
- Nicotine Abuse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Hospital
Tokat Province, Merkez, 60100
About this study
Official title: The Effect of General or Spinal Anesthesia on Pulmonary Function Tests in Geriatric Patients
The role of neuraxial anesthesia in preventing respiratory complications is a controversial in elderly patients. The aim of the study was to evaluate the benefits of neuraxial anesthesia on pulmonary function during post-operative term in geriatric patients undergoing to elective non-abdominal surgery.
Read the detailed description
Sixty elder patients will be randomly assigned to General anesthesia or Neuraxial anesthesia groups. Spirometry, will be performed at pre-operative and post-operative terms. Pulmonary function tests will be evaluated.
- Conditions
- Anesthesia, Geriatric Patients
- Being tested
- General anesthesia, Neuraxial anesthesia, Spirometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
induction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane)
Neuraxial anesthesiaProcedure or surgery
Spinal anesthesia will be applied via the local anesthetic ( Bupivacaine).
SpirometerDiagnostic test
Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Active comparator | Standard General Anesthesia will be applied.The change of the pulmonary functions will be evaluated via spirometer. Receives: Procedure: General anesthesia; Diagnostic Test: Spirometer |
| Neuraxial Anesthesia | Active comparator | Neuraxial anesthesia will be applied. The change of the pulmonary functions will be evaluated via spirometer. Receives: Procedure: Neuraxial anesthesia; Diagnostic Test: Spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes on forced vital capacity
Forced vital capacity will be measured via spirometer
Measured: At Preoperative, postoperative 2. hours, postoperative 24. hours
The changes on forced expiratory volume in 1 s
Forced expiratory volume in 1 s will be measured via spirometer
Measured: At Preoperative, postoperative 2. hours, postoperative 24. hours
The changes on mid-expiratory flow (MEF 25-75)
mid-expiratory flow (MEF 25-75) will be measured via spirometer
Measured: At Preoperative, postoperative 2. hours, postoperative 24. hours
The changes on peak expiratory flow (PEF)
Peak expiratory flow (PEF) will be measured by the spirometer
Measured: At Preoperative, postoperative 2. hours, postoperative 24. hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start16 Feb 2018
- Primary completion2 Dec 2018
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Tuğba Karaman, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399201
- Sponsor's protocol ID
- Spiro
- Status last verified
- Dec 2018
- First submitted
- 22 Dec 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of General or Spinal Anesthesia on Pulmonary Function Tests in Geriatric Patients
- ClinicalTrials.gov ID
- NCT03399201
- Acronym / sponsor ID
- Spiro
- Conditions
- Anesthesia, Geriatric Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 16 Jan 2018 (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.
The role of neuraxial anesthesia in preventing respiratory complications is a controversial in elderly patients. The aim of the study was to evaluate the benefits of neuraxial anesthesia on pulmonary function during post-operative term in geriatric patients undergoing to elective non-abdominal surgery.
Detailed description
Sixty elder patients will be randomly assigned to General anesthesia or Neuraxial anesthesia groups. Spirometry, will be performed at pre-operative and post-operative terms. Pulmonary function tests will be evaluated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Procedure: General anesthesia, Diagnostic Test: SpirometerStandard General Anesthesia will be applied.The change of the pulmonary functions will be evaluated via spirometer. |
| Neuraxial Anesthesia | Active comparator | Procedure: Neuraxial anesthesia, Diagnostic Test: SpirometerNeuraxial anesthesia will be applied. The change of the pulmonary functions will be evaluated via spirometer. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years of age
- Undergoing non-abdominal surgery under anesthesia in supine position
Key exclusion criteria (5 listed)
- Pulmonary disease
- Hematological disease
- Undergoing Abdominal surgery
- Non-supine position during surgery
- Nicotine Abuse
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 |
|---|---|---|
| General anesthesiainduction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane) | Procedure or surgery | General Anesthesia |
| Neuraxial anesthesiaSpinal anesthesia will be applied via the local anesthetic ( Bupivacaine). | Procedure or surgery | Neuraxial Anesthesia |
| SpirometerPulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy) | Diagnostic test | General Anesthesia, Neuraxial Anesthesia |
Primary outcome
The changes on forced vital capacity
Time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours
Forced vital capacity will be measured via spirometer
The changes on forced expiratory volume in 1 s
Time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours
Forced expiratory volume in 1 s will be measured via spirometer
The changes on mid-expiratory flow (MEF 25-75)
Time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours
mid-expiratory flow (MEF 25-75) will be measured via spirometer
The changes on peak expiratory flow (PEF)
Time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours
Peak expiratory flow (PEF) will be measured by the spirometer
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 19 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Tuğba Karaman, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia, Neuraxial anesthesia and Spirometer in people with Anesthesia and Geriatric Patients, run by Tokat Gaziosmanpasa 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 2 inclusion and 5 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 19 Dec 2018. 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?
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?
The changes on forced vital capacity (time frame: At Preoperative, postoperative 2. hours, postoperative 24. hours). The study lists 4 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 19 Dec 2018.