Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval

Conditions
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Oocyte Retrieval, Sedation, Conscious, Ventilatory Depression

Intervention / Treatment
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* Drug: Ketamine 150 ng/ml
* Drug: Remifentanil
* Procedure: Oocyte retrieval
* Drug: Ketamine 200 ng/ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients having an oocyte retrieval Exclusion Criteria: BMI > 30 endometriosis contraindications to ketamine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ketamine 150 ng/ml<br>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. | Drug: Ketamine 150 ng/ml<br>* conscious sedation in TCI-mode<br>* Other names: conscious sedation;Drug: Remifentanil<br>* conscious sedation in TCI-mode<br>* Other names: conscious sedation;Procedure: Oocyte retrieval<br>* Oocyte retrieval for In Vitro Fertilization<br>|
| ketamine 200 ng/ml<br>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. | Drug: Remifentanil<br>* conscious sedation in TCI-mode<br>* Other names: conscious sedation;Procedure: Oocyte retrieval<br>* Oocyte retrieval for In Vitro Fertilization<br>Drug: Ketamine 200 ng/ml<br>* conscious sedation in TCI-mode<br>* Other names: conscious sedation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory depression | respiratory rate (number of inspiration per minute) | through study completion, an average of 2 months | 
| Respiratory depression | SpO2 (%) | through study completion, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | EVA | 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. | through study completion, an average of 2 months | 
| pregnancy rate | HCG in the blood | 15 days after the oocyte retrieval | 
| ketamine dosage | blood sample (serum) | 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. | through study completion, an average of 2 months | 
| Arterial pressure | mmHg | through study completion, an average of 2 months | 
| Heart rate | Beats per minute | through study completion, an average of 2 months | 
| Pain | NOL-index | through study completion, an average of 2 months | 
| Pain | ANI | 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. | through study completion, an average of 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, remifentanil