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

Sponsor
Erasme University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03458143
Collaborator
(none)
20
Enrollment
1
Location
1.5
Anticipated Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ketamine 150 ng/ml
  • Drug: Remifentanil
  • Procedure: Oocyte retrieval
  • Drug: Ketamine 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval
Actual Study Start Date :
Feb 12, 2018
Anticipated Primary Completion Date :
Mar 31, 2018
Anticipated Study Completion Date :
Mar 31, 2018

Arms and Interventions

Arm Intervention/Treatment
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/ml
conscious sedation in TCI-mode
Other Names:
  • conscious sedation

    • Drug: Remifentanil
    conscious sedation in TCI-mode
    Other Names:
  • conscious sedation

    • Procedure: Oocyte retrieval
    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.

    Drug: Remifentanil
    conscious sedation in TCI-mode
    Other Names:
  • conscious sedation

    • Procedure: Oocyte retrieval
    Oocyte retrieval for In Vitro Fertilization

    Drug: Ketamine 200 ng/ml
    conscious sedation in TCI-mode
    Other Names:
  • conscious sedation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. respiratory depression [through study completion, an average of 2 months]

      respiratory rate (number of inspiration per minute)

    2. Respiratory depression [through study completion, an average of 2 months]

      SpO2 (%)

    Secondary Outcome Measures

    1. pain [through study completion, an average of 2 months]

      EVA

    2. patient satisfaction [through study completion, an average of 2 months]

      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.

    3. pregnancy rate [15 days after the oocyte retrieval]

      HCG in the blood

    4. ketamine dosage [through study completion, an average of 2 months]

      blood sample (serum)

    5. sedation level [through study completion, an average of 2 months]

      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.

    6. Arterial pressure [through study completion, an average of 2 months]

      mmHg

    7. Heart rate [through study completion, an average of 2 months]

      Beats per minute

    8. Pain [through study completion, an average of 2 months]

      NOL-index

    9. Pain [through study completion, an average of 2 months]

      ANI

    10. Sedation level [through study completion, an average of 2 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients having an oocyte retrieval
    Exclusion Criteria:

    • BMI > 30

    • endometriosis

    • contraindications to ketamine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erasme University Hospital Bruxelles Belgium 1070

    Sponsors and Collaborators

    • Erasme University Hospital

    Investigators

    • Principal Investigator: Peres-Bota Iulia, student, Erasme hospital
    • Study Director: Barvais Luc, MDPhD, Erasme hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luc Barvais, MD PhD, Erasme University Hospital
    ClinicalTrials.gov Identifier:
    NCT03458143
    Other Study ID Numbers:
    • P2018/016
    First Posted:
    Mar 8, 2018
    Last Update Posted:
    Mar 13, 2018
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Luc Barvais, MD PhD, Erasme University Hospital
    ketamine
    remifentanil
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Depression
    Depressive Disorder
    Ketamine
    Remifentanil

    Study Results

    No Results Posted as of Mar 13, 2018