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Desflurane Group for Anesthesia (OLIVER Trial)

N/A
Waitlist Available
Led By David MacLeod, MBBS
Research Sponsored by Medtronic - MITG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy (ASA physical status 1), male or female subjects between the ages of 18 to 60 years;
Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of anesthesia administration, up to 2 hours
Awards & highlights

OLIVER Trial Summary

This trial looks at how well the BIS monitor works with different types of anesthetics and opioids.

OLIVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

OLIVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of anesthesia administration, up to 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of anesthesia administration, up to 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BIS 50
Secondary outcome measures
BIS 95
Prediction Probability (PK)

OLIVER Trial Design

5Treatment groups
Active Control
Group I: Desflurane GroupActive Control1 Intervention
Due to desflurane being a volatile agent and not well tolerated as an induction agent, an initial IV bolus of 1% propofol provided at 2mg/kg, with supplemental boluses given at the investigators discretion in order to achieve laryngeal mask (LMA) insertion, will be administered 15-20 minutes prior to desflurane. Once correct LMA placement has been confirmed, there will be an equilibrium time of approximately 15-20 minutes to allow the effect site concentration of propofol to reach a level consistent with a pharmacodynamic effect of consciousness as measured by a MOAA/S score of 2 or 3. Desflurane will then be administered via a tight-face mask at the targeted end-tidal concentration (ETDES) of 2, 5, 7, 8, 9, 10 %, or higher until an MOAA/S score of less than 2 is reached. The BIS™ value will be correlated with desflurane ETDES concentration. ETDES is decreased by the same steps until consciousness is regained.
Group II: Sevoflurane aloneActive Control1 Intervention
Sevoflurane will be administered in steps to achieve a loss of consciousness via a tight-face mask by increasing the end-tidal concentration of Sevoflurane (ETSEVO). Targeted concentration for ETSEVO are 0.25, 0.5, 0.75, 1, 3, 4, 5% or higher until MOAA/S scales at values less than 2 is reached. The equilibration time for each targeted concentration will be approximately 12 minutes to maintain a constant ETSEVO. The BIS™ value, MOAA/S score and picture recall test will be assessed when the patient is awake and at the different ETSEVO concentrations. ETSEVO is decreased by the same steps until consciousness is regained.
Group III: Sevoflurane with Remifentanil GroupActive Control1 Intervention
Two (2) minutes before starting sevoflurane, to attain an effect-site targeted concentration of remifentanil of 4 ng/ml, an initial IV bolus of remifentanil will be given followed by the start of an infusion. Approximately within 7 minutes, the infusion rate of remifentanil may be adjusted to maintain the effect-site concentration of remifentanil of 4 ng/ml. Sevoflurane will be administered via a tight-face mask in steps to achieve a loss of consciousness by increasing the end-tidal concentration of Sevoflurane (ETSEVO). Targeted concentration for ETSEVO are 0.25, 0.5, 0.75, 1, 3, 4, 5% or higher until an MOAA/S score of less than 2 is reached. ETSEVO is decreased by the same steps until consciousness is regained.
Group IV: Sevoflurane with Fentanyl GroupActive Control1 Intervention
Two (2) minutes before starting sevoflurane, to attain an effect-site targeted concentration of fentanyl of 2 ng/mL, an initial IV bolus of fentanyl will be given followed by the start of an infusion. Approximately within 10 minutes, the infusion rate of fentanyl may be adjusted to maintain the effect-site concentration of fentanyl of 2 ng/ml. Sevoflurane will be administered via a tight-face mask in steps to achieve a loss of consciousness by increasing the end-tidal concentration of Sevoflurane (ETSEVO). Targeted concentration for ETSEVO are 0.25, 0.5, 0.75, 1, 3, 4, 5% or higher until an MOAA/S score of equal to or less than 2 is reached. ETSEVO is decreased by the same steps until consciousness is regained.
Group V: Isoflurane GroupActive Control1 Intervention
Due to isoflurane being a volatile agent and not well tolerated as an induction agent, an initial IV bolus of 1% propofol provided at 2mg/kg, with supplemental boluses given at the investigators discretion in order to achieve LMA insertion, will be administered 15-20 minutes prior to isoflurane.Isoflurane will be administered via a tight-face mask in steps to achieve a loss of consciousness (MOAA/S of 0,1) by increasing the end-tidal concentration of Isoflurane (ETISO). Targeted concentration for ETISO are 0.25, 0.5, 0.75, 1, 1.5% or higher until MOAA/S scales at values less than 2 is reached. The BIS™ value will be correlated with desflurane ETISO concentration. ETISO is decreased by the same steps until consciousness is regained.

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Who is running the clinical trial?

Medtronic - MITGLead Sponsor
252 Previous Clinical Trials
300,475 Total Patients Enrolled
David MacLeod, MBBSPrincipal InvestigatorDuke University
1 Previous Clinical Trials
21 Total Patients Enrolled

Frequently Asked Questions

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~52 spots leftby Mar 2025