Oocyte Retrieval, Sedation, Conscious, Ventilatory Depression
Conditions
Keywords
ketamine, remifentanil
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.
Interventions
DRUGKetamine 150 ng/ml
conscious sedation in TCI-mode
DRUGRemifentanil
conscious sedation in TCI-mode
PROCEDUREOocyte retrieval
Oocyte retrieval for In Vitro Fertilization
DRUGKetamine 200 ng/ml
conscious sedation in TCI-mode
Sponsors
Erasme University Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* patients having an oocyte retrieval
Exclusion criteria
* BMI \> 30 * endometriosis * contraindications to ketamine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory depression | through study completion, an average of 2 months | SpO2 (%) |
| respiratory depression | through study completion, an average of 2 months | respiratory rate (number of inspiration per minute) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rate | 15 days after the oocyte retrieval | HCG in the blood |
| ketamine dosage | through study completion, an average of 2 months | blood sample (serum) |
| sedation level | through study completion, an average of 2 months | 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. |
| pain | through study completion, an average of 2 months | EVA |
| Heart rate | through study completion, an average of 2 months | Beats per minute |
| Pain | through study completion, an average of 2 months | NOL-index |
| Sedation level | through study completion, an average of 2 months | 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. |
| Arterial pressure | through study completion, an average of 2 months | mmHg |
| patient satisfaction | through study completion, an average of 2 months | 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. |
Countries
Belgium
Contacts
Primary Contactbarvais luc, MD PhD
Outcome results
None listed