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NCT Number: NCT07671781

Processed EEG Monitoring During Controlled Hypotension in Patients Undergoing Rhinoplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

Controlled hypotension is commonly used during rhinoplasty to improve surgical field visibility and reduce bleeding. However, the adequacy and safety of controlled hypotension should not be evaluated only by hemodynamic variables. Processed EEG monitoring may provide additional information about hypnotic depth and the probability of response to nociceptive stimulation.

In this prospective observational study, adult patients undergoing elective rhinoplasty under general anesthesia were monitored with standard ASA monitoring and processed EEG monitoring. Total intravenous anesthesia was maintained with propofol and remifentanil. Esmolol infusion was used as part of the controlled hypotension strategy. Intraoperative qCON and qNOX values, hemodynamic parameters, surgical bleeding scores, anesthetic drug consumption, extubation time, time to reach Aldrete score ≥9, and early postoperative cognitive recovery were recorded.

The primary objective is to evaluate the intraoperative course of qCON and qNOX values during controlled hypotension. Secondary objectives are to assess the relationship of processed EEG parameters with recovery quality, early postoperative cognitive status, anesthetic drug consumption, and surgical field bleeding.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Intraoperative qCON and qNOX values during controlled hypotension

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

    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.

Secondary outcomes

  1. Heart rate during controlled hypotension

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

    Heart rate will be recorded at predefined intraoperative time points to evaluate hemodynamic stability.

Other outcomes

  1. Surgical field bleeding score

    Time frame: Intraoperatively, from surgical incision until the end of surgery.

    Surgical field bleeding will be evaluated using the Boezaart surgical field bleeding score at predefined intraoperative time points.

  2. Extubation time

    Time frame: At the end of surgery

    Time from discontinuation of anesthetic agents to extubation will be recorded in minutes

  3. Time to reach Aldrete score ≥9

    Time frame: Early postoperative recovery period, immediately after extubation.

    The time required to reach an Aldrete recovery score of 9 or higher will be recorded in minutes

  4. Early postoperative delirium assessed by the Nursing Delirium Screening Scale

    Time frame: At admission to the post-anesthesia care unit

    Patients were assessed for early postoperative delirium in the post-anesthesia care unit using the Nursing Delirium Screening Scale (Nu-DESC). The Nu-DESC ranges from 0 to 10, with higher scores indicating more severe delirium symptoms.

  5. Total anesthetic drug consumption

    Time frame: From anesthesia induction until the end of surgery

    Total intraoperative consumption of propofol, remifentanil, and esmolol will be recorded

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Observational Evaluation of the Relationship Between Intraoperative Processed EEG Monitoring,Surgical Bleeding and Recovery Quality in Patients Undergoing Rhinoplasty Under Controlled Hypotension

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

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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