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

Free University of Brussels (ULB)

Status: Unknown

Conditions: Oocyte Retrieval; Sedation, Conscious; Ventilatory Depression

Treatments: Drug: Ketamine 200 ng/ml; Procedure: Oocyte retrieval; Drug: Ketamine 150 ng/ml; Drug: Remifentanil

Study type: Observational

Funder types: Other

Identifiers

NCT03458143

P2018/016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients having an oocyte retrieval

Exclusion criteria

• BMI > 30
• endometriosis
• contraindications to ketamine

Trial design

20 participants in 2 patient groups

ketamine 150 ng/ml

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Ketamine 150 ng/ml

Procedure: Oocyte retrieval

ketamine 200 ng/ml

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Ketamine 200 ng/ml

Procedure: Oocyte retrieval