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

Ventilatory Depression Clinical Trial

Official title:

Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03458143
• Other study ID #: P2018/016
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2018
• Last updated: March 9, 2018
• Start date: February 12, 2018
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2018
• Source: Erasme University Hospital
• Contact: barvais luc, MD PhD
• Phone: +3225553919
• Email: luc.barvais[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients having an oocyte retrieval

Exclusion Criteria:

• BMI > 30

• endometriosis

• contraindications to ketamine

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Oocyte Retrieval
• Respiratory Insufficiency
• Sedation, Conscious
• Ventilatory Depression

Intervention

Drug:
• Ketamine 150 ng/ml
conscious sedation in TCI-mode
• Remifentanil
conscious sedation in TCI-mode

Procedure:
• Oocyte retrieval
Oocyte retrieval for In Vitro Fertilization

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

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory depression	respiratory rate (number of inspiration per minute)	through study completion, an average of 2 months
Primary	Respiratory depression	SpO2 (%)	through study completion, an average of 2 months
Secondary	pain	EVA	through study completion, an average of 2 months
Secondary	patient satisfaction	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.	through study completion, an average of 2 months
Secondary	pregnancy rate	HCG in the blood	15 days after the oocyte retrieval
Secondary	ketamine dosage	blood sample (serum)	through study completion, an average of 2 months
Secondary	sedation level	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.	through study completion, an average of 2 months
Secondary	Arterial pressure	mmHg	through study completion, an average of 2 months
Secondary	Heart rate	Beats per minute	through study completion, an average of 2 months
Secondary	Pain	NOL-index	through study completion, an average of 2 months
Secondary	Pain	ANI	through study completion, an average of 2 months
Secondary	Sedation level	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.	through study completion, an average of 2 months