RhinoplastyNCT07671781
Processed EEG Monitoring During Controlled Hypotension in Patients Undergoing Rhinoplasty
An observational study of Rhinoplasty and Depth of Anesthesia, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluates intraoperative processed electroencephalography parameters in adult patients undergoing elective rhinoplasty under total intravenous anesthesia with controlled hypotension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinoplasty, Depth of Anesthesia, Surgical Bleeding
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 25 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Evaluation of the Relationship Between Intraoperative Processed EEG Monitoring,Surgical Bleeding and Recovery Quality in Patients Undergoing Rhinoplasty Under Controlled Hypotension
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.
Read the detailed description
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.
- Keywords
- processed EEG, qCON, qNOX, rhinoplasty, esmolol, TIVA, recovery quality, controlled hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
Secondary outcomes (1)
Heart rate during controlled hypotension
Heart rate will be recorded at predefined intraoperative time points to evaluate hemodynamic stability.
Measured: From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Nov 2025
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif KARAKAYA, Gazi University
- Investigators
- Nurdan Bedirli, MD, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671781
- Sponsor's protocol ID
- 172
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional and ethical restrictions and to protect participant confidentiality.
Publications
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.
PubMed 38215709Kol 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.
PubMed 24683230Aldecoa 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.
PubMed 37599617
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Evaluation of the Relationship Between Intraoperative Processed EEG Monitoring,Surgical Bleeding and Recovery Quality in Patients Undergoing Rhinoplasty Under Controlled Hypotension
- ClinicalTrials.gov ID
- NCT07671781
- Acronym / sponsor ID
- 172
- Keywords
- processed EEG, qCON, qNOX, rhinoplasty, esmolol, TIVA, recovery quality, controlled hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Heart rate during controlled hypotension
Time frame: From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 38215709Laferriere-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.
- Background: PubMed 24683230Kol 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.
- Background: PubMed 37599617Aldecoa 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional and ethical restrictions and to protect participant confidentiality.
Related trials for Rhinoplasty
Active, not recruiting
Hybrid Osteoplasty Versus Osteotomy in Rhinoplasty
Rhinoplasty Techniques
Not yet recruitingObservational study
Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty
Nasal Septum Deviation, Rhinoplasty
RecruitingObservational study
Patient-Reported Outcomes and Complications After Structural Rhinoplasty Using Septal Extension Grafts
Nasal Deformity, Rhinoplasty
Not yet recruiting
AI in Assessing Aesthetic Outcomes in Rhinoplasty
Rhinoplasty, AI (Artificial Intelligence)
Enrolling by invitationPhase 3
Efficacy of Liposomal Bupivacaine Post Septorhinoplasty
Rhinoplasty, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurdan Bedirli, MD study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinoplasty and Depth of Anesthesia, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07671781, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.