Oocyte RetrievalNCT03458143
Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval
An observational study of Oocyte Retrieval and Sedation, Conscious, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
This study evaluates the effect of the addition of ketamine to a conscious sedation protocol including remifentanil during oocyte retrieval. The investigators will have 2 groups with different target effect site concentrations, namely 150 ng/ml and 200 ng/ml. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Retrieval, Sedation, Conscious, Ventilatory Depression
- What is being tested?
- Ketamine 150 ng/ml, Remifentanil and Oocyte retrieval
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Feb 2018to 31 Mar 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital.
Who may be able to join
- patients having an oocyte retrieval
Who cannot join
- BMI > 30
- endometriosis
- contraindications to ketamine
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Erasme University Hospital
Brussels, 1070
Luc Barvais, phd, Luc.Barvais@erasme.ulb.ac.be
Peres-Bota Iulia, student, Iulia.Peres-bota@ulb.ac.be
About this study
Official title: Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval
This study evaluates the effect of the addition of ketamine to a conscious sedation protocol including remifentanil during oocyte retrieval. The investigators will have 2 groups with different target effect site concentrations, namely 150 ng/ml and 200 ng/ml.
Read the detailed description
The actual protocol for conscious sedation during oocyte retrieval in at the Erasmus hospital (Brussels) consists of Remifentanil in TCI-mode, with premedication by Midazolam. However, episodes of bradypnaea with or without desaturation are still common.
The primary objective is to observe if with the addition of ketamine, it is possible to significantly reduce the dose of Remifentanil, in order to avoid episodes of respiratory depression caused by the opioid.
The secondary outcomes measured, will be the pain levels experienced by the patient, the sedation level, and the satisfaction of the patients after the procedure.
- Being tested
- Ketamine 150 ng/ml, Remifentanil, Oocyte retrieval, Ketamine 200 ng/ml
- Keywords
- ketamine, remifentanil
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 150 ng/mlDrug
Also called conscious sedation
conscious sedation in TCI-mode
RemifentanilDrug
Also called conscious sedation
conscious sedation in TCI-mode
Oocyte retrievalProcedure or surgery
Oocyte retrieval for In Vitro Fertilization
Ketamine 200 ng/mlDrug
Also called conscious sedation
conscious sedation in TCI-mode
| Study group | Role | What they receive |
|---|---|---|
| ketamine 150 ng/ml | The first group will receive the classical premedication with 2 mg of Midazolam. A bolus dose of Ketamine will be given, then to be titrated in TCI mode with a target concentration of 150 ng/ml. Right after, the Remifentanil TCI will be started at a concentration of 1 ng/ml and the procedure can begin. Receives: Drug: Ketamine 150 ng/ml; Drug: Remifentanil; Procedure: Oocyte retrieval | |
| ketamine 200 ng/ml | The second group will be treated in the exact way as the first, with the exception that the target effect site concentration is aimed at 200 ng/ml. Receives: Drug: Remifentanil; Procedure: Oocyte retrieval; Drug: Ketamine 200 ng/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory depression
respiratory rate (number of inspiration per minute)
Measured: through study completion, an average of 2 months
Respiratory depression
SpO2 (%)
Measured: through study completion, an average of 2 months
Secondary outcomes (10)
pain
EVA
Measured: through study completion, an average of 2 months
patient satisfaction
satisfaction scale: 1=unsatisfied. 2=average satisfaction 3=Satisfied 4=very satisfied. The higher the value, the better. Additionally, we ask the patients if they would choose the same anesthetic method, should it be necessary to repeat the procedure. If yes, it is considered a better outcome.
Measured: through study completion, an average of 2 months
pregnancy rate
HCG in the blood
Measured: 15 days after the oocyte retrieval
ketamine dosage
blood sample (serum)
Measured: through study completion, an average of 2 months
sedation level
OAAS: Observer's Assessment Of Alertness/Sedation Scale. 5=Responds readily to name spoken in normal tone. 4=Lethargic response to name spoken in normal tone. 3=Response only after name is called loudly and/or repeatedly. 2=Response only after mild prodding or shaking. 1=Response only after paintful trapezius squeeze. 0=No response after paintful trapezius squeeze. Values higher than 3 represents a better outcome.
Measured: through study completion, an average of 2 months
Arterial pressure
mmHg
Measured: through study completion, an average of 2 months
Heart rate
Beats per minute
Measured: through study completion, an average of 2 months
Pain
NOL-index
Measured: through study completion, an average of 2 months
Pain
ANI
Measured: through study completion, an average of 2 months
Sedation level
Ramsay sedation scale. 1=Anxious and agitated or restless, or both. 2=Co-operative, oriented, and calm. 3=Responsive to commands only. 4=Exhibiting brisk response to light glabellar tap or loud auditory stimulus. 5=Exhibiting a sluggish response to light glabellar tap or loud auditory stimulus. 6=unresponsive. Values of 2-3 represent the better outcome.
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start12 Feb 2018
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte RetrievalStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Barvais, Erasme University Hospital
- Investigators
- Peres-Bota Iulia, student, Principal investigator, Erasme University HospitalBarvais Luc, MDPhD, Study director, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458143
- Sponsor's protocol ID
- P2018/016
- Status last verified
- Mar 2018
- First submitted
- 14 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval
- ClinicalTrials.gov ID
- NCT03458143
- Acronym / sponsor ID
- P2018/016
- Keywords
- ketamine, remifentanil
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 8 Mar 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.
This study evaluates the effect of the addition of ketamine to a conscious sedation protocol including remifentanil during oocyte retrieval. The investigators will have 2 groups with different target effect site concentrations, namely 150 ng/ml and 200 ng/ml.
Detailed description
The actual protocol for conscious sedation during oocyte retrieval in at the Erasmus hospital (Brussels) consists of Remifentanil in TCI-mode, with premedication by Midazolam. However, episodes of bradypnaea with or without desaturation are still common.
The primary objective is to observe if with the addition of ketamine, it is possible to significantly reduce the dose of Remifentanil, in order to avoid episodes of respiratory depression caused by the opioid.
The secondary outcomes measured, will be the pain levels experienced by the patient, the sedation level, and the satisfaction of the patients after the procedure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine 150 ng/ml | – | Drug: Ketamine 150 ng/ml, Drug: Remifentanil, Procedure: Oocyte retrievalThe first group will receive the classical premedication with 2 mg of Midazolam. A bolus dose of Ketamine will be given, then to be titrated in TCI mode with a target concentration of 150 ng/ml. Right after, the Remifentanil TCI will be started at a concentration of 1 ng/ml and the procedure can begin. |
| ketamine 200 ng/ml | – | Drug: Remifentanil, Procedure: Oocyte retrieval, Drug: Ketamine 200 ng/mlThe second group will be treated in the exact way as the first, with the exception that the target effect site concentration is aimed at 200 ng/ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital.
Key inclusion criteria (1 listed)
- patients having an oocyte retrieval
Key exclusion criteria (3 listed)
- BMI > 30
- endometriosis
- contraindications to ketamine
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 |
|---|---|---|
| Ketamine 150 ng/mlAlso: conscious sedationconscious sedation in TCI-mode | Drug | ketamine 150 ng/ml |
| RemifentanilAlso: conscious sedationconscious sedation in TCI-mode | Drug | ketamine 150 ng/ml, ketamine 200 ng/ml |
| Oocyte retrievalOocyte retrieval for In Vitro Fertilization | Procedure or surgery | ketamine 150 ng/ml, ketamine 200 ng/ml |
| Ketamine 200 ng/mlAlso: conscious sedationconscious sedation in TCI-mode | Drug | ketamine 200 ng/ml |
Primary outcome
respiratory depression
Time frame: through study completion, an average of 2 months
respiratory rate (number of inspiration per minute)
Respiratory depression
Time frame: through study completion, an average of 2 months
SpO2 (%)
10 secondary outcomes
pain
Time frame: through study completion, an average of 2 months
patient satisfaction
Time frame: through study completion, an average of 2 months
pregnancy rate
Time frame: 15 days after the oocyte retrieval
ketamine dosage
Time frame: through study completion, an average of 2 months
sedation level
Time frame: through study completion, an average of 2 months
Arterial pressure
Time frame: through study completion, an average of 2 months
Heart rate
Time frame: through study completion, an average of 2 months
Pain
Time frame: through study completion, an average of 2 months
Pain
Time frame: through study completion, an average of 2 months
Sedation level
Time frame: through study completion, an average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
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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.
Peres-Bota Iulia, student principal investigator
Erasme University Hospital
Barvais Luc, MDPhD study director
Erasme University Hospital
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 Oocyte Retrieval and Sedation, Conscious, run by Erasme University Hospital at 1 site in Belgium.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact barvais luc, MD PhD (+3225553919, luc.barvais@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
respiratory depression (time frame: through study completion, an average of 2 months). The study lists 2 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 13 Mar 2018.