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

• Conditions: Oocyte Retrieval; Sedation, Conscious; Ventilatory Depression
• Interventions: Drug: Ketamine 150 ng/ml; Procedure: Oocyte retrieval; Drug: Remifentanil; Drug: Ketamine 200 ng/ml

• Registration Number: NCT03458143
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-02-12
• Study First Submitted: 2018-02-14
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-08
• Last Update Submitted: 2018-03-09
• Last Update Posted: 2018-03-13
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• patients having an oocyte retrieval

Exclusion Criteria

• BMI > 30
• endometriosis
• contraindications to ketamine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ketamine 200 ng/ml	Oocyte retrieval	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.
ketamine 150 ng/ml	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.
ketamine 150 ng/ml	Oocyte retrieval	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.
ketamine 200 ng/ml	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.
ketamine 150 ng/ml	Remifentanil	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.
ketamine 200 ng/ml	Remifentanil	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.

Primary Outcome Measures

Name	Time	Method
respiratory depression	through study completion, an average of 2 months	respiratory rate (number of inspiration per minute)
Respiratory depression	through study completion, an average of 2 months	SpO2 (%)

Secondary Outcome Measures

Name	Time	Method
pregnancy rate	15 days after the oocyte retrieval	HCG in the blood
ketamine dosage	through study completion, an average of 2 months	blood sample (serum)
Arterial pressure	through study completion, an average of 2 months	mmHg
pain	through study completion, an average of 2 months	EVA
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.
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.
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.
Pain	through study completion, an average of 2 months	ANI
Heart rate	through study completion, an average of 2 months	Beats per minute

Trial Locations

Locations (1)

Erasme University Hospital; 🇧🇪 Bruxelles, Belgium