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

• ClinicalTrials.gov Identifier: NCT03458143
• Recruitment Status: Unknown
• First Posted: March 8, 2018
• Last Update Posted: March 13, 2018
• Sponsor: Erasme University Hospital
• 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

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

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

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