NCT03458143

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

February 14, 2018

Last Update Submit

March 9, 2018

Conditions

Oocyte RetrievalSedation, ConsciousVentilatory Depression

Keywords

ketamineremifentanil

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • pain

    through study completion, an average of 2 months

  • patient satisfaction

    through study completion, an average of 2 months

  • pregnancy rate

    15 days after the oocyte retrieval

  • ketamine dosage

    through study completion, an average of 2 months

  • sedation level

    through study completion, an average of 2 months

  • +5 more secondary outcomes

Study Arms (2)

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.

Drug: Ketamine 150 ng/mlDrug: RemifentanilProcedure: Oocyte retrieval

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.

Drug: RemifentanilProcedure: Oocyte retrievalDrug: Ketamine 200 ng/ml

Interventions

Ketamine 150 ng/mlDRUG

conscious sedation in TCI-mode

Also known as: conscious sedation
ketamine 150 ng/ml
RemifentanilDRUG

conscious sedation in TCI-mode

Also known as: conscious sedation
ketamine 150 ng/mlketamine 200 ng/ml
Oocyte retrievalPROCEDURE

Oocyte retrieval for In Vitro Fertilization

ketamine 150 ng/mlketamine 200 ng/ml
Ketamine 200 ng/mlDRUG

conscious sedation in TCI-mode

Also known as: conscious sedation
ketamine 200 ng/ml

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital.

You may qualify if:

  • patients having an oocyte retrieval

You may not qualify if:

  • BMI \> 30
  • endometriosis
  • contraindications to ketamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma/Serum for Ketamine dosage after the procedure

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

KetamineConscious SedationRemifentanilOocyte Retrieval

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnesthesia and AnalgesiaPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsReproductive Techniques, AssistedReproductive TechniquesTherapeuticsTissue and Organ HarvestingTransplantationSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Peres-Bota Iulia, student

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

  • Barvais Luc, MDPhD

    Erasme University Hospital

    STUDY DIRECTOR

Central Study Contacts

barvais luc, MD PhD

CONTACT

+3225553919luc.barvais@erasme.ulb.ac.be

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 14, 2018

First Posted

March 8, 2018

Study Start

February 12, 2018

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

BE(1)