Processed EEG Monitoring During Controlled Hypotension in Patients Undergoing Rhinoplasty

NCT07671781 | Completed

• 1 other identifier: 172
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study evaluates intraoperative processed electroencephalography parameters in adult patients undergoing elective rhinoplasty under total intravenous anesthesia with controlled hypotension. The study focuses on qCON and qNOX values during anesthesia, their relationship with early postoperative recovery, and their association with intraoperative surgical bleeding and surgical field quality.

Conditions

Rhinoplasty; Depth of Anesthesia; Surgical Bleeding; Postoperative Recovery

Keywords

processed EEG; qCON, qNOX; rhinoplasty; esmolol; TIVA; recovery quality; controlled hypotension

Outcome Measures

Primary Outcomes (1)

• Intraoperative qCON and qNOX values during controlled hypotension

  qCON and qNOX values obtained by processed EEG monitoring will be recorded at predefined intraoperative time points. qCON will be used as an index of hypnotic depth, and qNOX will be used as an index of the probability of response to nociceptive stimulation.

  From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.

Secondary Outcomes (1)

• Heart rate during controlled hypotension

  From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.

Other Outcomes (5)

• Surgical field bleeding score

  Intraoperatively, from surgical incision until the end of surgery.

• Extubation time

  At the end of surgery

• Time to reach Aldrete score ≥9

  Early postoperative recovery period, immediately after extubation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective rhinoplasty under general anesthesia at Gazi University Faculty of Medicine were included in this prospective observational study. All patients underwent total intravenous anesthesia with esmolol-supported controlled hypotension and intraoperative processed EEG monitoring. Hemodynamic parameters, qCON and qNOX values, surgical bleeding scores, anesthetic drug consumption, and early postoperative recovery outcomes were recorded.

You may qualify if:

• Patients aged 18 years or older
• Patients scheduled for elective rhinoplasty
• Patients classified as ASA physical status I-II
• Patients planned to undergo general anesthesia with total intravenous anesthesia
• Patients in whom frontal processed EEG electrodes can be applied
• Patients who provide written informed consent

You may not qualify if:

• Emergency surgery
• Severe neurological disease
• Scalp lesion or marked dermatitis preventing processed EEG electrode placement
• Communication or hearing impairment preventing postoperative assessment
• Marked hemodynamic instability
• Multiple trauma or need for postoperative intensive care unit admission
• Pregnancy

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Laferriere-Langlois P, Morisson L, Jeffries S, Duclos C, Espitalier F, Richebe P. Depth of Anesthesia and Nociception Monitoring: Current State and Vision For 2050. Anesth Analg. 2024 Feb 1;138(2):295-307. doi: 10.1213/ANE.0000000000006860. Epub 2024 Jan 12.

  PMID: 38215709 BACKGROUND

• Kol IO, Kaygusuz K, Yildirim A, Dogan M, Gursoy S, Yucel E, Mimaroglu C. Controlled hypotension with desflurane combined with esmolol or dexmedetomidine during tympanoplasty in adults: A double-blind, randomized, controlled trial. Curr Ther Res Clin Exp. 2009 Jun;70(3):197-208. doi: 10.1016/j.curtheres.2009.06.001.

  PMID: 24683230 BACKGROUND

• Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Aceto P, Audisio R, Cherubini A, Cunningham C, Dabrowski W, Forookhi A, Gitti N, Immonen K, Kehlet H, Koch S, Kotfis K, Latronico N, MacLullich AMJ, Mevorach L, Mueller A, Neuner B, Piva S, Radtke F, Blaser AR, Renzi S, Romagnoli S, Schubert M, Slooter AJC, Tommasino C, Vasiljewa L, Weiss B, Yuerek F, Spies CD. Update of the European Society of Anaesthesiology and Intensive Care Medicine evidence-based and consensus-based guideline on postoperative delirium in adult patients. Eur J Anaesthesiol. 2024 Feb 1;41(2):81-108. doi: 10.1097/EJA.0000000000001876. Epub 2023 Aug 30.

  PMID: 37599617 BACKGROUND

Study Officials

• Nurdan Bedirli, MD

  Gazi University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 26, 2026
• Study Start: November 1, 2025
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)