Comparison of Target-Controlled Infusion (TCI) vs continuous infusion of remimazolam for drug induced sleep endoscopy (DISE): a prospective clinical study

Comparison of TCI propofol vs continuous infusion of remimazolam for drug induced sleep endoscopy (DISE) in adults: a prospective clinical study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001234505

Enrollment

Registered

2024-10-09

Start date

2024-10-21

Completion date

2026-10-01

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to compare the effectiveness of TCI propofol and continuous infusion remimazolam in sedation for drug induced sleep endoscopy, with an emphasis on the required wake-up time after the procedure. Participants will be divided into two group (one recieving sedation via TCI Propofol and the other via remimazolam infusion).The following data will be recorded: informed consent for anesthesia and information on admission, informed consent for the study, demographic and clinical characteristics of the patient (age, sex, height, weight, BMI, ASA status, Mallampati score, comorbidities and previous use of CPAP machine), time from the start of the infusion to reaching BIS 60, the drug dose that was needed to achieve BIS 60/snoring , time to snoring, time from stopping the infusion until BIS 80 is achieved, number of episodes of desaturation, necessary additional maneuvers to maintain the airway patency if we used them. Hemodinamics will be measured during the whole procedure (blood pressure, heart rate and oxygen saturation) every 5 minutes. We assume that remimazolam will prove to be more efficient than propofol, meaninig faster to achieve sedation, faster wake up time and less hemodinamic instability.

Interventions

Patients scheduled for drug induced sleep endoscopy will be divaded in 2 groups. One will be sedated using target control infusion of propofol -1-3mcg/ml while the other group will be sedated using continous infusion of remimazolam 0,5-2 mg/kg/hour. Sedation will be administered by specialist of anesthesiology and will be monitored by observation and bispectral index monitoring.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

patient scheduled for drug induced sleep endoscopy

Exclusion criteria

Patients who are allergic to eggs, milk, soy, propofol or midazolam, then patients with BMI higher than 40, pregnant women and patients with ASA status 3 and above will be excluded

Outcome results