An observational study in Oocyte Retrieval, Sedation, Conscious and Ventilatory Depression, sponsored by Erasme University Hospital. Status unknown at 1 site in Belgium. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-13.
Sponsored by Erasme University Hospital · Observational
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.
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.
Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital.
Exclusion Criteria:
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 · Drug: Remifentanil · Procedure: Oocyte retrieval
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 · Procedure: Oocyte retrieval · Drug: Ketamine 200 ng/ml
conscious sedation in TCI-mode
Also known as: conscious sedation
conscious sedation in TCI-mode
Also known as: conscious sedation
Oocyte retrieval for In Vitro Fertilization
conscious sedation in TCI-mode
Also known as: conscious sedation
respiratory depression
respiratory rate (number of inspiration per minute)
Time frame: through study completion, an average of 2 months
Respiratory depression
SpO2 (%)
Time frame: through study completion, an average of 2 months
pain
EVA
Time frame: 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.
Time frame: through study completion, an average of 2 months
pregnancy rate
HCG in the blood
Time frame: 15 days after the oocyte retrieval
ketamine dosage
blood sample (serum)
Time frame: 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.
Time frame: through study completion, an average of 2 months
Arterial pressure
mmHg
Time frame: through study completion, an average of 2 months
Heart rate
Beats per minute
Time frame: through study completion, an average of 2 months
Pain
NOL-index
Time frame: through study completion, an average of 2 months
Pain
ANI
Time frame: 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.
Time frame: through study completion, an average of 2 months
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Erasme University Hospital