NauseaNCT00452855
Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea
A study testing Sevoflurane-remifentanil anaesthesia in people with Nausea and Vomiting, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- What is being tested?
- Sevoflurane-remifentanil anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2002to May 2005
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females younger than 50 years
- ASA I-II
- Scheduled to gynaecological laparotomies or laparoscopies
Who cannot join
- Medication known to act anti-emetic
- ASA status greater than II
- Malignant hyperthermia
- Allergy to the drugs used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Nausea and Vomiting Are Similar When Propofol or Sevoflurane Are Used as Adjuvant to Remifentanil During Anaesthesia for Gynaecological Surgery
The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.
Read the detailed description
Propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion.
Propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post operative nausea and vomiting (PONV) as PONV is diminished. However, when remifentanil is used as adjuvant to sevoflurane, the total dose of the latter is reduced.
Therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total PONV during 24 hours.
In the post anaesthesia care unit (PACU) and in the surgical ward nausea was scored on a visual analogue score. Vomiting was registered.
- Being tested
- Sevoflurane-remifentanil anaesthesia
- Keywords
- Nausea, Vomiting, Post operative, Propofol remifentanil anaesthesia, Sevoflurane remifentanil anaesthesia
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane-remifentanil anaesthesiaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea, incidence and intensity ( VAS score )in PACU and surgical ward
Vomiting, incidence in PACU and surgical ward
Total PONV after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startJan 2002
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nielsen, Jens OD, M.D.
- Investigators
- Jens Ole Dich JO Nielsen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452855
- Sponsor's protocol ID
- PropSevoRemi
- Status last verified
- Mar 2007
- First submitted
- 26 Mar 2007
- Last updated
- 29 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Nausea and Vomiting Are Similar When Propofol or Sevoflurane Are Used as Adjuvant to Remifentanil During Anaesthesia for Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT00452855
- Acronym / sponsor ID
- PropSevoRemi
- Keywords
- Nausea, Vomiting, Post operative, Propofol remifentanil anaesthesia, Sevoflurane remifentanil anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- Nielsen, Jens OD, M.D.
- Study start
- Jan 2002
- Study completion
- May 2005 (actual)
- First posted
- 28 Mar 2007 (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 purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.
Detailed description
Propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion.
Propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post operative nausea and vomiting (PONV) as PONV is diminished. However, when remifentanil is used as adjuvant to sevoflurane, the total dose of the latter is reduced.
Therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total PONV during 24 hours.
In the post anaesthesia care unit (PACU) and in the surgical ward nausea was scored on a visual analogue score. Vomiting was registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Females younger than 50 years
- ASA I-II
- Scheduled to gynaecological laparotomies or laparoscopies
Key exclusion criteria (4 listed)
- Medication known to act anti-emetic
- ASA status greater than II
- Malignant hyperthermia
- Allergy to the drugs used.
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-remifentanil anaesthesia | Procedure or surgery | – |
Primary outcome
Nausea, incidence and intensity ( VAS score )in PACU and surgical ward
Vomiting, incidence in PACU and surgical ward
Total PONV after 24 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 29 Mar 2007.
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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.
Jens Ole Dich JO Nielsen, MD principal investigator
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-remifentanil anaesthesia in people with Nausea and Vomiting, run by Central Jutland Regional Hospital at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 29 Mar 2007. 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 Denmark. 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?
Nausea, incidence and intensity ( VAS score )in PACU and surgical ward. The study lists 3 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 29 Mar 2007; AzTrials last refreshed its copy on 8 Nov 2026.