Brainwave Entrainment During Emergence

NCT05736510 | Unknown

• 1 other identifier: 2212-028-1383
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will compare whether there is a significant difference in the time required for general anesthesia recovery according to application of the binaural sound after surgery.

Conditions

Anesthesia, General

Keywords

Brain Waves; anesthesia

Outcome Measures

Primary Outcomes (1)

• Eye opening time

  The time it takes to open patient's eyes in response to the voice after the anesthetic infusion is terminated.

  after the anesthetic infusion is terminated until 1 hour

Secondary Outcomes (15)

• Extubation time

  after the anesthetic infusion is terminated until 1 hour

• Systolic blood pressure

  from the end of the anesthetic infusion to the exit of operating room until 1 hour

• Diastolic blood pressure

  from the end of the anesthetic infusion to the exit of operating room until 1 hour

• Mean blood pressure

  from the end of the anesthetic infusion to the exit of operating room until 1 hour

• Heart rate

  from the end of the anesthetic infusion to the exit of operating room until 1 hour

Study Arms (2)

Binaural

EXPERIMENTAL

Exposed to binaural sound (40 Hz) from the end of pneumoperitoneum until the eyes are open

Other: Binaural sound

Control

ACTIVE COMPARATOR

Applied silent files from the end of pneumoperitoneum until the eyes are open

Other: Control

Interventions

Binaural sound OTHER

When the pneumoperitoneum ends, the anesthesiologist puts headphones on the patient and plays the allocated file. In the experimental group, the allocated file is binaural sound with 40Hz beat. Thereafter, the target of PSI is to be between 40 and 50. If the Psi increases above 50, increase the propofol concentration by 0.5 mg/mL and record it. Train of four counts keep between 1 to 3 (moderate block). When the operation is ended, stop anesthetics administration, and, we reverse neuromuscular blocking using sugammadex (2mg/ kg). When the anesthesiologist starts waking the patient up, call the patient's name (unify into "OOO, open your eyes."). The anesthesiologist lightly tap the patient's shoulder and avoid excessive sound or stimulation.

Binaural

Control OTHER

When the pneumoperitoneum ends, the anesthesiologist puts headphones on the patient and plays the allocated file. In the control group, the allocated file is silent. Thereafter, the target of PSI is to be between 40 and 50. If the Psi increases above 50, increase the propofol concentration by 0.5 mg/mL and record it. Train of four counts keep between 1 to 3 (moderate block). When the operation is ended, stop anesthetics administration, and, we reverse neuromuscular blocking using sugammadex (2mg/ kg). When the anesthesiologist starts waking the patient up, call the patient's name (unify into "OOO, open your eyes."). The anesthesiologist lightly tap the patient's shoulder and avoid excessive sound or stimulation.

Control

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between 19 and 50 years of age who are scheduled to undergo laparoscopic salpingo-oophorectomy/ ovarian cystectomy
• Intellectual level to understand the procedures of the clinical trial
• Physical status classification of the American Society of Anesthesiology (ASA) 1-2 grades

You may not qualify if:

• Patients with hearing loss or using hearing aids
• Patients who have been given narcotic painkillers or sedative drugs within a week.
• Alcohol-dependent or drug-dependent patients
• Patients with drug hypersensitivity to anesthetics
• Patients with arrhythmia, cardiovascular disease, impaired heart function, decreased circulatory blood flow
• Patients with liver failure
• Patients with other major medical or psychological disorder that will affect the treatment response
• Patients with claustrophobia or anxiety disorder
• Patients with organic brain disorders or other conditions that cannot be properly measured by PSI
• Patients who have been newly diagnosed with myocardial infarction, cerebral ischemic seizure, stroke, clinically significant coronary artery disease, or have undergone percutaneous carotid coronary dilatation or coronary bypass treatment within 6 months
• Patients with a history of epilepsy or seizures
• Patients with acute angle glaucoma
• Patients who deemed unsuitable for this clinical trial

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (2)

• Schmid W, Marhofer P, Opfermann P, Zadrazil M, Kimberger O, Triffterer L, Marhofer D, Klug W. Brainwave entrainment to minimise sedative drug doses in paediatric surgery: a randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):330-335. doi: 10.1016/j.bja.2020.05.050. Epub 2020 Jul 8.

  PMID: 32653082 BACKGROUND

• Ozkose Z, Yalcin Cok O, Tuncer B, Tufekcioglu S, Yardim S. Comparison of hemodynamics, recovery profile, and early postoperative pain control and costs of remifentanil versus alfentanil-based total intravenous anesthesia (TIVA). J Clin Anesth. 2002 May;14(3):161-8. doi: 10.1016/s0952-8180(01)00368-3.

  PMID: 12031745 BACKGROUND

Study Officials

• Jeong-Hwa Seo, MD.,PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-Hwa Seo, MD.,PhD.

CONTACT

+82-10-55020551; eongpa@empas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment A prospective randomized study

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 21, 2023
• Study Start: February 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: February 23, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)