Lung FunctionPhase 4NCT00706277
Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function
A Phase 4 study testing propofol, remifentanil and fentanyl in people with Lung Function, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA; propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl; maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30 minutes after emergence from the general… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lung Function
- What is being tested?
- propofol, remifentanil and fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2008to Dec 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA 1-2
- BMI normal
Who cannot join
- lung disease
- Nicotine abuse
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA; propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl; maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30 minutes after emergence from the general anesthesia.
- Conditions
- Lung Function
- Being tested
- propofol, remifentanil, fentanyl, Sevoflurane/Nitrous Oxide
- Keywords
- forced vital capacity, forced expired volume in 1 s
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
propofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour
propofolDrug
propofol 2mg
remifentanilDrug
remifentanil 0,25mcg/kg/hour
fentanylDrug
fentanyl 100mcg
Sevoflurane/Nitrous OxideDrug
maintenance of anesthesia with sevoflurane and nitrous oxide
| Study group | Role | What they receive |
|---|---|---|
| TIVA | Active comparator | patients receiving total intravenous anesthesia (TIVA) Receives: Drug: propofol; Drug: remifentanil |
| balanced | Active comparator | patients receiving balanced anesthesia Receives: Drug: propofol; Drug: fentanyl; Drug: Sevoflurane/Nitrous Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 forced expiratory volume; FVC forced vital capacity
Measured: preoperative, 30 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJun 2008
- Study completionDec 2008
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 Lung FunctionStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Investigators
- Arnulf Benzer, MD, Principal investigator, TILAK Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706277
- Sponsor's protocol ID
- 2007-007161-25
- Status last verified
- Feb 2009
- First submitted
- 25 Jun 2008
- Last updated
- 10 Feb 2009
- Results posted
- No
Publications
Gunnarsson L, Lindberg P, Tokics L, Thorstensson O, Thorne A. Lung function after open versus laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 1995 Apr;39(3):302-6. doi: 10.1111/j.1399-6576.1995.tb04066.x.
PubMed 7793205Regli A, von Ungern-Sternberg BS, Reber A, Schneider MC. Impact of spinal anaesthesia on peri-operative lung volumes in obese and morbidly obese female patients. Anaesthesia. 2006 Mar;61(3):215-21. doi: 10.1111/j.1365-2044.2005.04441.x.
PubMed 16480344Natalini G, Franceschetti ME, Pletti C, Recupero D, Lanza G, Bernardini A. Impact of laryngeal mask airway and tracheal tube on pulmonary function during the early postoperative period. Acta Anaesthesiol Scand. 2002 May;46(5):525-8. doi: 10.1034/j.1399-6576.2002.460509.x.
PubMed 12027846
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function
- ClinicalTrials.gov ID
- NCT00706277
- Acronym / sponsor ID
- 2007-007161-25
- Conditions
- Lung Function
- Keywords
- forced vital capacity, forced expired volume in 1 s
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jun 2008
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Jun 2008 (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.
The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA; propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl; maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30 minutes after emergence from the general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA | Active comparator | Drug: propofol, Drug: remifentanilpatients receiving total intravenous anesthesia (TIVA) |
| balanced | Active comparator | Drug: propofol, Drug: fentanyl, Drug: Sevoflurane/Nitrous Oxidepatients receiving balanced anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA 1-2
- BMI normal
Key exclusion criteria (2 listed)
- lung disease
- 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 |
|---|---|---|
| propofolpropofol 2mg/kg for induction of anesthesia; followed by propofol 6 mg/kg/hour | Drug | TIVA |
| propofolpropofol 2mg | Drug | balanced |
| remifentanilremifentanil 0,25mcg/kg/hour | Drug | TIVA |
| fentanylfentanyl 100mcg | Drug | balanced |
| Sevoflurane/Nitrous Oxidemaintenance of anesthesia with sevoflurane and nitrous oxide | Drug | balanced |
Primary outcome
FEV1 forced expiratory volume; FVC forced vital capacity
Time frame: preoperative, 30 minutes postoperative
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 10 Feb 2009.
- Background: PubMed 7793205Gunnarsson L, Lindberg P, Tokics L, Thorstensson O, Thorne A. Lung function after open versus laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 1995 Apr;39(3):302-6. doi: 10.1111/j.1399-6576.1995.tb04066.x.
- Background: PubMed 16480344Regli A, von Ungern-Sternberg BS, Reber A, Schneider MC. Impact of spinal anaesthesia on peri-operative lung volumes in obese and morbidly obese female patients. Anaesthesia. 2006 Mar;61(3):215-21. doi: 10.1111/j.1365-2044.2005.04441.x.
- Background: PubMed 12027846Natalini G, Franceschetti ME, Pletti C, Recupero D, Lanza G, Bernardini A. Impact of laryngeal mask airway and tracheal tube on pulmonary function during the early postoperative period. Acta Anaesthesiol Scand. 2002 May;46(5):525-8. doi: 10.1034/j.1399-6576.2002.460509.x.
Related trials for Lung Function
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
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.
Arnulf Benzer, MD principal investigator
TILAK Hospitals
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 propofol, remifentanil and fentanyl in people with Lung Function, run by Medical University Innsbruck at 1 site in Austria.
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 2 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 10 Feb 2009. 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 Austria. 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 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?
FEV1 forced expiratory volume; FVC forced vital capacity (time frame: preoperative, 30 minutes postoperative). 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 NCT00706277, 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 10 Feb 2009.