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Recruiting

NCT Number: NCT06497283

Binaural Sound for Remimazolam Maintenance

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.

Recruiting

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Key information

Conditions

General Anesthesia Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Prostate Cancer Stage Skin and Connective Tissue Diseases Uterine Myoma

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Hyun Chang Kim

CONTACT

82-2-2019-4601

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
  • Patients with liver failure

Treatment and study plan

Binaural sound

Procedure

Binaural sound: Binaural sound will be applied.

Primary outcomes

  1. Intraoperative remifentanil dose

    Time frame: At anesthesia day 0

    Intraoperative remifentanil dose will be measured at anesthesia day 0.

Secondary outcomes

  1. Intraoperative remimazolam dose

    Time frame: At anesthesia day 0

    Intraoperative remimazolam dose will be measured at anesthesia day 0.

  2. Pain score (0:no pain, 10:maximal pain)

    Time frame: At anesthesia day 0 and 1

    Pain score (0:no pain, 10:maximal pain) will be measured at anesthesia day 0 and 1.

  3. Electroencephalography

    Time frame: At anesthesia day 0

    The relative power of alpha, beta, delta, gamma, and theta band in electroencephalography will be measured at anesthesia day 0.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyun-Chang Kim

CONTACT

[email protected]

0220194601

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

The Effect of Intraoperative Binaural Sound on Remifentanil Dose Required for General Anesthesia Using Remimazolam: a Randomized, Placebo-controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Aug 9, 2024

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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