SurgeryNCT02583217
Effect of Ketamine+Propofol vs Remifentanyl+Propofol on Laryngeal Mask Insertion Conditions
An observational study of Surgery, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Laryngeal mask airway is a common tool for airway management during anesthesia in many surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile hemodynamic response. Many drug regimens has been used for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Surgery
- What is being tested?
- Ketamine, remifentanyl and propofol
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2015to Jan 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Surgery performed with laryngeal mask as airway tool in gynecologic clinic
Who may be able to join
- Surgery requires laryngeal mask
Who cannot join
- Patient refusal, abdominal surgery required muscle relaxant, any allergy to ketamine or remifentanyl
Trial locations and contacts
1 site in 1 country.
About this study
Laryngeal mask airway is a common tool for airway management during anesthesia in many surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to compare the insertion conditions of laryngeal mask by using ketamine+propofol versus remifentanil + propofol.
- Conditions
- Surgery
- Keywords
- Laryngeal mask, Ketamine, Remifentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Remifentanyl
To compare ketamine+propofol versus remifentanyl+propofol to maintain good laryngeal mask insertion conditions
remifentanylDrug
propofolDrug
laryngeal maskDevice
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Ketamine+propofol Receives: Drug: Ketamine; Drug: propofol; Device: laryngeal mask | |
| Remifentanyl | Remifentanyl+propofol Receives: Drug: remifentanyl; Drug: propofol; Device: laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
High laryngeal mask insertion scores
Measured: 3 minutes
Secondary outcomes (2)
Hypotension
Measured: 10 minutes
Hypertension
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
- Investigators
- CIGDEM YILDIRIM GUCLU, MD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583217
- Sponsor's protocol ID
- ANK-42476
- Status last verified
- Jan 2016
- First submitted
- 18 Sep 2015
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketamine+Propofol vs Remifentanyl+Propofol on Laryngeal Mask Insertion Conditions
- ClinicalTrials.gov ID
- NCT02583217
- Acronym / sponsor ID
- ANK-42476
- Conditions
- Surgery
- Keywords
- Laryngeal mask, Ketamine, Remifentanyl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Oct 2015 (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.
Laryngeal mask airway is a common tool for airway management during anesthesia in many surgeries. Insertion of laryngeal mask needs deep anesthesia, suppression of airway, stabile hemodynamic response. Many drug regimens has been used for this purpose. This study aimed to compare the insertion conditions of laryngeal mask by using ketamine+propofol versus remifentanil + propofol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | – | Drug: Ketamine, Drug: propofol, Device: laryngeal maskKetamine+propofol |
| Remifentanyl | – | Drug: remifentanyl, Drug: propofol, Device: laryngeal maskRemifentanyl+propofol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgery performed with laryngeal mask as airway tool in gynecologic clinic
Key inclusion criteria (1 listed)
- Surgery requires laryngeal mask
Key exclusion criteria (1 listed)
- Patient refusal, abdominal surgery required muscle relaxant, any allergy to ketamine or remifentanyl
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 |
|---|---|---|
| KetamineAlso: RemifentanylTo compare ketamine+propofol versus remifentanyl+propofol to maintain good laryngeal mask insertion conditions | Drug | Ketamine |
| remifentanyl | Drug | Remifentanyl |
| propofol | Drug | Ketamine, Remifentanyl |
| laryngeal mask | Device | Ketamine, Remifentanyl |
Primary outcome
High laryngeal mask insertion scores
Time frame: 3 minutes
2 secondary outcomes
Hypotension
Time frame: 10 minutes
Hypertension
Time frame: 10 minutes
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 8 May 2017.
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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.
CIGDEM YILDIRIM GUCLU, MD principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Ankara 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 1 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 8 May 2017. 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?
High laryngeal mask insertion scores (time frame: 3 minutes). 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 8 May 2017.