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

Ketamine

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.

Intervention / Treatment

  • Ketamine 150 ng/ml (DRUG)
    conscious sedation in TCI-mode
  • Remifentanil (DRUG)
    conscious sedation in TCI-mode
  • Oocyte retrieval (PROCEDURE)
    Oocyte retrieval for In Vitro Fertilization
  • Ketamine 200 ng/ml (DRUG)
    conscious sedation in TCI-mode

Condition or Disease

  • Oocyte Retrieval
  • Sedation, Conscious
  • Ventilatory Depression

Phase

Study Design

Study type: OBSERVATIONAL
Status: Unknown status
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 20 (ESTIMATED)
Funded by: Other
Time Perspective: Prospective
Observational Model: Other

Masking

Clinical Trial Dates

Start date: Feb 12, 2018 ACTUAL
Primary Completion: Mar 31, 2018 ESTIMATED
Completion Date: Mar 31, 2018 ESTIMATED
Study First Posted: Mar 08, 2018 ACTUAL
Results First Posted: Aug 31, 2020
Last Updated: Mar 09, 2018

Sponsors / Collaborators

Lead Sponsor: Erasme University Hospital
Responsible Party: N/A

Location

Brussels, Belgium

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.

Participant Groups

  • 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.

  • 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.

Eligibility Criteria

Sex: Female
Minimum Age: 18
Age Groups: Adult / Older Adult
Healthy Volunteers: Yes

Inclusion Criteria:

* patients having an oocyte retrieval

Exclusion Criteria:

* BMI \> 30
* endometriosis
* contraindications to ketamine

Primary Outcomes

  • respiratory rate (number of inspiration per minute)

  • SpO2 (%)

Secondary Outcomes

  • EVA

  • 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.

  • HCG in the blood

  • blood sample (serum)

  • 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.

  • mmHg

  • Beats per minute

  • NOL-index

  • ANI

  • 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.

More Details

NCT Number: NCT03458143
Other IDs: P2018/016
Study URL: https://clinicaltrials.gov/study/NCT03458143
Last updated: Sep 29, 2023