Binaural Sound for Remimazolam Maintenance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorGangnam Severance Hospital
About this trial
It is important to decrease the remifentanil dose for general anesthesia maintenance when using remimazolam. We will evaluate the effect of binaural sound on general anesthesia maintenance with remimazolam infusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for general anesthesia
Patients aged 20-60
Patients with American Society of Anesthesiologist physical status classification 1-2
Patients with ideal body weight 50-80 kg
Disqualifiers
Patients with hearing disability
Patients using opioids or sedatives in 1 week
Patients who are dependent for alcoholics or drugs
Patients with hypersensitivities to remimazolam or remifentanil
Trial design
Design model
Parallel
Treatments tested in this trial
Binaural sound
Procedure/SurgeryBinaural sound: Binaural sound will be applied.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: I (Binaural)Experimental treatment 1 intervention
Group B: II (Placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative remifentanil dose
Intraoperative remifentanil dose will be measured at anesthesia day 0.
Time frame
At anesthesia day 0Secondary outcomes
1
Intraoperative remimazolam dose
Intraoperative remimazolam dose will be measured at anesthesia day 0.
Time frame
At anesthesia day 02
Pain score (0:no pain, 10:maximal pain)
Pain score (0:no pain, 10:maximal pain) will be measured at anesthesia day 0 and 1.
Time frame
At anesthesia day 0 and 13
Electroencephalography
The relative power of alpha, beta, delta, gamma, and theta band in electroencephalography will be measured at anesthesia day 0.
Time frame
At anesthesia day 0Sponsors and contacts
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Source ClinicalTrials.gov