Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458143
Recruitment Status : Unknown
Verified March 2018 by Luc Barvais, Erasme University Hospital.
Recruitment status was:  Recruiting
First Posted : March 8, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Luc Barvais, Erasme University Hospital

Tracking Information
First Submitted Date February 14, 2018
First Posted Date March 8, 2018
Last Update Posted Date March 13, 2018
Actual Study Start Date February 12, 2018
Estimated Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2018)
  • respiratory depression [ Time Frame: through study completion, an average of 2 months ]
    respiratory rate (number of inspiration per minute)
  • Respiratory depression [ Time Frame: through study completion, an average of 2 months ]
    SpO2 (%)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 9, 2018)
  • pain [ Time Frame: through study completion, an average of 2 months ]
    EVA
  • 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.
  • pregnancy rate [ Time Frame: 15 days after the oocyte retrieval ]
    HCG in the blood
  • ketamine dosage [ Time Frame: through study completion, an average of 2 months ]
    blood sample (serum)
  • 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.
  • Arterial pressure [ Time Frame: through study completion, an average of 2 months ]
    mmHg
  • Heart rate [ Time Frame: through study completion, an average of 2 months ]
    Beats per minute
  • Pain [ Time Frame: through study completion, an average of 2 months ]
    NOL-index
  • Pain [ Time Frame: through study completion, an average of 2 months ]
    ANI
  • 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.
Original Secondary Outcome Measures
 (submitted: March 1, 2018)
  • pain [ Time Frame: through study completion, an average of 2 months ]
    EVA
  • patient satisfaction [ Time Frame: through study completion, an average of 2 months ]
    satisfaction scale
  • pregnancy rate [ Time Frame: 15 days after the oocyte retrieval ]
    HCG in the blood
  • ketamine dosage [ Time Frame: through study completion, an average of 2 months ]
    blood sample (serum)
  • sedation level [ Time Frame: through study completion, an average of 2 months ]
    OAAS
  • Arterial pressure [ Time Frame: through study completion, an average of 2 months ]
    mmHg
  • Heart rate [ Time Frame: through study completion, an average of 2 months ]
    Beats per minute
  • Pain [ Time Frame: through study completion, an average of 2 months ]
    NOL-index
  • Pain [ Time Frame: through study completion, an average of 2 months ]
    ANI
  • Sedation level [ Time Frame: through study completion, an average of 2 months ]
    Ramsay scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Respiratory Depression During an Analgosedation Combining Remifentanil and Ketamine in TCI for Oocyte Retrieval
Official Title Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval
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.
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma/Serum for Ketamine dosage after the procedure
Sampling Method Non-Probability Sample
Study Population Female patients in good health, with informed consent, undergoing oocyte retrieval at the Erasmus Hospital.
Condition
  • Oocyte Retrieval
  • Sedation, Conscious
  • Ventilatory Depression
Intervention
  • 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
  • Drug: Ketamine 200 ng/ml
    conscious sedation in TCI-mode
    Other Name: conscious sedation
Study Groups/Cohorts
  • 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.
    Interventions:
    • Drug: Ketamine 150 ng/ml
    • Drug: Remifentanil
    • Procedure: 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.
    Interventions:
    • Drug: Remifentanil
    • Procedure: Oocyte retrieval
    • Drug: Ketamine 200 ng/ml
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 1, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2018
Estimated Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients having an oocyte retrieval

Exclusion Criteria:

  • BMI > 30
  • endometriosis
  • contraindications to ketamine
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03458143
Other Study ID Numbers P2018/016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Luc Barvais, Erasme University Hospital
Study Sponsor Erasme University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Peres-Bota Iulia, student Erasme Hospital
Study Director: Barvais Luc, MDPhD Erasme Hospital
PRS Account Erasme University Hospital
Verification Date March 2018