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Trial record 21 of 49 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Belgium )

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

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ClinicalTrials.gov Identifier: NCT03458143
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Luc Barvais, Erasme University 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.

Condition or disease Intervention/treatment
Oocyte Retrieval Sedation, Conscious Ventilatory Depression 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.


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Study Type : Observational
Estimated 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 : February 12, 2018
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: conscious sedation

Drug: Remifentanil
conscious sedation in TCI-mode
Other Name: 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 Name: conscious sedation

Procedure: Oocyte retrieval
Oocyte retrieval for In Vitro Fertilization

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




Primary Outcome Measures :
  1. respiratory depression [ Time Frame: through study completion, an average of 2 months ]
    respiratory rate (number of inspiration per minute)

  2. Respiratory depression [ Time Frame: through study completion, an average of 2 months ]
    SpO2 (%)


Secondary Outcome Measures :
  1. pain [ Time Frame: through study completion, an average of 2 months ]
    EVA

  2. patient satisfaction [ Time Frame: 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 [ Time Frame: 15 days after the oocyte retrieval ]
    HCG in the blood

  4. ketamine dosage [ Time Frame: through study completion, an average of 2 months ]
    blood sample (serum)

  5. sedation level [ Time Frame: 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 [ Time Frame: through study completion, an average of 2 months ]
    mmHg

  7. Heart rate [ Time Frame: through study completion, an average of 2 months ]
    Beats per minute

  8. Pain [ Time Frame: through study completion, an average of 2 months ]
    NOL-index

  9. Pain [ Time Frame: through study completion, an average of 2 months ]
    ANI

  10. Sedation level [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Plasma/Serum for Ketamine dosage after the procedure


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital.
Criteria

Inclusion Criteria:

  • patients having an oocyte retrieval

Exclusion Criteria:

  • BMI > 30
  • endometriosis
  • contraindications to ketamine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458143


Contacts
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Contact: barvais luc, MD PhD +3225553919 luc.barvais@erasme.ulb.ac.be

Locations
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Belgium
Erasme University Hospital Recruiting
Bruxelles, Belgium, 1070
Contact: Luc Barvais, phd       Luc.Barvais@erasme.ulb.ac.be   
Contact: Peres-Bota Iulia, student       Iulia.Peres-bota@ulb.ac.be   
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Peres-Bota Iulia, student Erasme Hospital
Study Director: Barvais Luc, MDPhD Erasme Hospital

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Responsible Party: Luc Barvais, MD PhD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03458143     History of Changes
Other Study ID Numbers: P2018/016
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luc Barvais, Erasme University Hospital:
ketamine
remifentanil
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Respiratory Insufficiency
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Ketamine
Remifentanil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics