Clinical trial NCT03458143: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oocyte Retrieval
Sedation, Conscious
Ventilatory Depression
Keywords: ketamine
remifentanil
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital.

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.

Eligibility criteria: Inclusion Criteria:

* patients having an oocyte retrieval

Exclusion Criteria:

* BMI \> 30
* endometriosis
* contraindications to ketamine

Primary outcomes:
measure: respiratory depression
timeFrame: through study completion, an average of 2 months
measure: Respiratory depression
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
measure: pain
timeFrame: through study completion, an average of 2 months
measure: patient satisfaction
timeFrame: through study completion, an average of 2 months
measure: pregnancy rate
timeFrame: 15 days after the oocyte retrieval
measure: ketamine dosage
timeFrame: through study completion, an average of 2 months
measure: sedation level
timeFrame: through study completion, an average of 2 months
measure: Arterial pressure
timeFrame: through study completion, an average of 2 months
measure: Heart rate
timeFrame: through study completion, an average of 2 months
measure: Pain
timeFrame: through study completion, an average of 2 months
measure: Pain
timeFrame: through study completion, an average of 2 months
measure: Sedation level
timeFrame: through study completion, an average of 2 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Erasme hospital
name: Peres-Bota Iulia, student
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasme hospital
name: Barvais Luc, MDPhD
role: STUDY_DIRECTOR
References: