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

NCT ID: NCT03458143

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-12

Study Completion Date

2018-03-31

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.

Conditions

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Oocyte Retrieval Sedation, Conscious Ventilatory Depression

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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ketamine 150 ng/ml

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.

Ketamine 150 ng/ml

Intervention Type DRUG

conscious sedation in TCI-mode

Remifentanil

Intervention Type DRUG

conscious sedation in TCI-mode

Oocyte retrieval

Intervention Type PROCEDURE

Oocyte retrieval for In Vitro Fertilization

ketamine 200 ng/ml

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.

Remifentanil

Intervention Type DRUG

conscious sedation in TCI-mode

Oocyte retrieval

Intervention Type PROCEDURE

Oocyte retrieval for In Vitro Fertilization

Ketamine 200 ng/ml

Intervention Type DRUG

conscious sedation in TCI-mode

Interventions

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Ketamine 150 ng/ml

conscious sedation in TCI-mode

Intervention Type DRUG

Remifentanil

conscious sedation in TCI-mode

Intervention Type DRUG

Oocyte retrieval

Oocyte retrieval for In Vitro Fertilization

Intervention Type PROCEDURE

Ketamine 200 ng/ml

conscious sedation in TCI-mode

Intervention Type DRUG

Other Intervention Names

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conscious sedation conscious sedation conscious sedation

Eligibility Criteria

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Inclusion Criteria

* patients having an oocyte retrieval

Exclusion Criteria

* BMI \> 30
* endometriosis
* contraindications to ketamine
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Luc Barvais

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peres-Bota Iulia, student

Role: PRINCIPAL_INVESTIGATOR

Erasme hospital

Barvais Luc, MDPhD

Role: STUDY_DIRECTOR

Erasme hospital

Locations

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Erasme University Hospital

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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barvais luc, MD PhD

Role: CONTACT

+3225553919

Facility Contacts

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Luc Barvais, phd

Role: primary

Peres-Bota Iulia, student

Role: backup

Other Identifiers

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P2018/016

Identifier Type: -

Identifier Source: org_study_id

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