Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval
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ClinicalTrials.gov Identifier: NCT03458143 |
Recruitment Status : Unknown
Verified March 2018 by Luc Barvais, Erasme University Hospital.
Recruitment status was: Recruiting
First Posted : March 8, 2018
Last Update Posted : March 13, 2018
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Tracking Information | |||||||
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First Submitted Date | February 14, 2018 | ||||||
First Posted Date | March 8, 2018 | ||||||
Last Update Posted Date | March 13, 2018 | ||||||
Actual Study Start Date | February 12, 2018 | ||||||
Estimated Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
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Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval | ||||||
Official Title | Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval | ||||||
Brief 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. | ||||||
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. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples Without DNA Description: Plasma/Serum for Ketamine dosage after the procedure
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Sampling Method | Non-Probability Sample | ||||||
Study Population | Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital. | ||||||
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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Estimated Enrollment |
20 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | March 31, 2018 | ||||||
Estimated Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Belgium | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03458143 | ||||||
Other Study ID Numbers | P2018/016 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Luc Barvais, Erasme University Hospital | ||||||
Study Sponsor | Erasme University Hospital | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Erasme University Hospital | ||||||
Verification Date | March 2018 |