Healthy AdultsPhase 4NCT01437462
Sevoflurane, Propofol, Postoperative Pain
A Phase 4 study testing Sevoflurane and Propofol in people with Healthy Adults and Gynecological Disease, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not proven in a large-scale study. The researchers aim to provide an investigation that has sufficient power to clarify the potential effect of anaesthetic method on postoperative need of opioids. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Healthy Adults, Gynecological Disease
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- How many people
- 168 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2008to Mar 2013
- 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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-69 years
- Gender: female
- ASA status 1-3
- Laparoscopic hysterectomy
Who cannot join
- Body Mass Index over 35
- Diabetes mellitus
- Liver disease
- Allergies to pharmaceuticals used in the Study
- Present use of opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain After Propofol Sevoflurane Anaesthesia: a Prospective, Randomized, Single-blinded Trial
The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not proven in a large-scale study. The researchers aim to provide an investigation that has sufficient power to clarify the potential effect of anaesthetic method on postoperative need of opioids. Sevoflurane and propofol will be compared.
- Conditions
- Healthy Adults, Gynecological Disease
- Being tested
- Sevoflurane, Propofol
- Keywords
- Pain, Postoperative, Anesthetics, intravenous, Anesthetics, inhalation, Otherwise healthy adults undergoing general anesthesia for gynecological disease.
- Medical subject headings
- Genital Diseases, Female, Pain, Postoperative, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Baxter Sevofluran
Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery
PropofolDrug
Also called Propofol Lipuro
Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative consumption of an opioid (oxycodone)
The consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump.
Measured: 20 hours
Secondary outcomes (1)
NRS (numeral rating scale) of pain
NRS is evaluated frequently during the study period.
Measured: 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startOct 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arvi Yli-Hankala, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437462
- Sponsor's protocol ID
- Satu_Pokkinen_01_2011
- Status last verified
- Apr 2013
- First submitted
- 19 Sep 2011
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Propofol Sevoflurane Anaesthesia: a Prospective, Randomized, Single-blinded Trial
- ClinicalTrials.gov ID
- NCT01437462
- Acronym / sponsor ID
- Satu_Pokkinen_01_2011
- Conditions
- Healthy Adults, Gynecological Disease
- Keywords
- Pain, Postoperative, Anesthetics, intravenous, Anesthetics, inhalation, Otherwise healthy adults undergoing general anesthesia for gynecological disease.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Sep 2011 (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 impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not proven in a large-scale study. The researchers aim to provide an investigation that has sufficient power to clarify the potential effect of anaesthetic method on postoperative need of opioids. Sevoflurane and propofol will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-69 years
- Gender: female
- ASA status 1-3
- Laparoscopic hysterectomy
Key exclusion criteria (5 listed)
- Body Mass Index over 35
- Diabetes mellitus
- Liver disease
- Allergies to pharmaceuticals used in the Study
- Present use of opioids
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: Baxter SevofluranSevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery | Drug | – |
| PropofolAlso: Propofol LipuroPropofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery | Drug | – |
Primary outcome
Postoperative consumption of an opioid (oxycodone)
Time frame: 20 hours
The consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump.
1 secondary outcome
NRS (numeral rating scale) of pain
Time frame: 20 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 10 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Propofol in people with Healthy Adults and Gynecological Disease, run by Tampere University Hospital at 1 site in Finland.
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 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 10 Apr 2013. 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 Finland. 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?
Postoperative consumption of an opioid (oxycodone) (time frame: 20 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 10 Apr 2013.