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Completed

NCT Number: NCT04866433

The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine

The aim of the study is to evaluate whether real-time binaural sound affects the dose of dexmedetomidine in patients undergoing sedation with dexmedetomidine after spinal anesthesia.

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Key information

Conditions

Sedative Adverse Reaction

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

Patients undergoing sedation with dexmedetomidine after spinal anesthesia are randomly assigned to binaural group, audio group, and control group. After spinal anesthesia, SedLine continuous monitoring is started. Real-time binaural sound applied music is played to the binaural group, normal music is played to the audio group, and headphones with no sound are applied to the control group. Observer's Assessment of Alertness/Sedation Scale (OAAS) and Patient State Index (PSi) are checked every minute after loading of dexmedetomidine at the rate of 1 μg/kg for 10 minutes (6 μg/kg/hr). Loading is stopped when the OAAS score is 3 or less. Then, dexmedetomidine is continuously infused at a rate of 0.6 μg/kg/hr, and OAAS is evaluated every 30 minutes. The infusion rate is lowered (-0.1 μg/kg/hr) if OAAS is lower than 3, and increased (+0.1 μg/kg/hr) if OAAS is higher than 3. The continuous infusion rate should not exceed 1 μg/kg/hr. The total dexmedetomidine dose corrected by the patient's predicted body weight and infusion time (μg/kg/hr) was compared between groups. In addition, the loading dose (μg/kg) and continuous infusion dose (μg/kg/hr), additional sedative use, blood pressure, heart rate, ECG changes, respiratory depression, and oxygen saturation were observed. The patient's satisfaction is evaluated after the surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients undergoing sedation with dexmedetomidine during spinal anesthesia for surgery with an estimated time of 90 minutes or longer

Exclusion criteria

  • ASA physical status classification 3-4
  • Patients with hearing loss or using hearing aids
  • Patients who received narcotic analgesics or sedative drugs within 1 week
  • Patients with alcohol dependence or drug dependence
  • Patients with drug hypersensitivity to dexmedetomidine
  • Patients with arrhythmia, cardiovascular disease, decreased cardiac function and decreased cardiac output
  • Patients who are judged to be difficult to use sedative drugs due to severe respiratory disease
  • Patients with liver failure
  • Patients with kidney failure or on dialysis
  • Patients judged to be unsuitable for the clinical trial by the researchers
  • Patients whose actual operation time is less than 30 minutes

Treatment and study plan

Real-time binaural sound

Procedure

Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.

Music

Procedure

Play the same music in both ears through headphones during sedation

Control

Procedure

Just wear headphones during sedation

Primary outcomes

  1. Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)

    Time frame: Intraoperative (During sedation for surgery)

    Dexmedetomidine loading dose injected until OAAS reaches 3 or less (μg/kg)

Secondary outcomes

  1. Observer's Assessment of Alertness/Sedation Scale (0~5)

    Time frame: During sedation for surgery and at post anesthesia care unit (PACU)

    Observer's Assessment of Alertness/Sedation Scale (0, does not respond to painful trapezius squeeze; 1, responds only after painful trapezius squeeze; 2, responds only after mild prodding or shaking; 3, responds only after name is called loudly, repeatedly, or both; 4, responds lethargically to name spoken in normal tone; 5, responds readily to name spoken in normal tone)

  2. Patient State Index (PSi)

    Time frame: Intraoperative (During sedation for surgery)

    Patient State Index (PSi) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)

  3. Dexmedetomidine continuous infusion dose

    Time frame: Intraoperative (During sedation for surgery)

    Total amount of dexmedetomidine infused from the end of dexmedetomidine loading to the start of suturing the surgical site

  4. Number of patients requiring additional sedatives

    Time frame: Intraoperative (During sedation for surgery)

    Number of patients requiring additional sedatives

  5. Adverse event

    Time frame: Intraoperative (During sedation for surgery)

    Incidence of hypotension, hypertension, bradycardia, ECG change, need of vasopressors, respiratory suppression, desaturation

  6. Patient satisfaction

    Time frame: Intraoperative (At the time of leaving the operating room)

    Patient's satisfaction with intraoperative sedation Score from 0 to 10) with intraoperative sedation measured at the time of leaving the operating room (0~10)

  7. Postanesthesia recovery score (0~10)

    Time frame: At the postanesthesia recovery room

    Postanesthesia recovery score (0~10, higher scores mean better recovery)

  8. Postoperative delirium

    Time frame: From the end of the surgery to the hospital discharge, an average of 1 week

    Incidence of postoperative delirium

Other outcomes

  1. EEG power in delta band

    Time frame: During sedation for surgery

    EEG power in delta band (0.3~4Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)

  2. EEG power in theta band

    Time frame: During sedation for surgery

    EEG power in theta band (4~8Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)

  3. EEG power in alpha band

    Time frame: During sedation for surgery

    EEG power in alpha band (8~13Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)

  4. EEG power in beta band

    Time frame: During sedation for surgery

    EEG power in beta band (13~30Hz) acquired through the Sedline Sedation monitor (Sedline, Massimo, USA)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effect of Real-time Binaural Sound on Sedation Using Dexmedetomidine During Spinal Anesthesia: a Randomized, Placebo-controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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