The Effects of Three Different Anesthetic Methods on Postoperative Agitation

May 6, 2026 updated by: Ülkü Özgül, Inonu University

Comparison of the Effects of Three Different Anesthetic Methods on Postoperative Agitation in Septoplasty Surgery

Adult patients undergoing septoplasty surgery will be evaluated in this study. The three different anesthesia methods used will be examined for psotoperative agitation: Total intravenous anesthesia (TIVA), Combined anesthesia with sevoflurane and intravenous agents (sevoflurane-CIVIA), Balanced inhalation anesthesia with sevoflurane. Recovery patterns is extubation time, eye opening time, emergence agitation, postoperative nausea and vomiting and postoperative recovery unit discharge time.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia. It can lead to respiratory depression, nausea, and vomiting, as well as increases in blood pressure, heart rate, and myocardial oxygen consumption. Hypoxia can lead to serious complications such as aspiration pneumonia, bleeding, or reoperation. Although its pathogenesis remains unclear, ear, nose, and throat (ENT) surgical procedures have been reported to have a higher incidence of agitation in both adults and children.

Classic general anesthesia is performed with induction using an intravenous hypnotic such as propofol and maintenance with a volatile anesthetic such as sevoflurane, along with intermittent or continuous opioids and muscle relaxants. Opinions differ regarding the effects of inhalational and intravenous anesthesia on maintenance. A 2015 retrospective study investigating the risk factors for emergence agitation after rhinoplasty reported that sevoflurane use more than doubled the risk of emergence agitation.

The use of propofol and sevoflurane for maintenance has recently been recommended due to the antiemetic effects of propofol, the myocardial protective effects of sevoflurane, and the potential for smoother emergence from the administration of small amounts of each anesthetic . This study aimed to compare the occurrence of emergence agitation after inhalation anesthesia, total intravenous anesthesia with TCI, and combined inhalation and intravenous anesthesia in patients undergoing septoplasty surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 50 years old.
  • American Society of Anesthesiologists (ASA) Physical Status Class I or II.
  • Scheduled for elective septoplasty surgery.
  • Scheduled to receive general anesthesia

Exclusion Criteria:

  • History of revision septoplasty
  • Known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) or the study drugs
  • History of bleeding disorder
  • History of allergy
  • ASA Physical Status greater than III
  • Body Mass Index (BMI) $> 30
  • History of hypertension, cardiovascular diseases, or cerebrovascular diseases
  • History of renal dysfunction
  • Use of psychiatric medications
  • History of substance abuse
  • Patients who refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group S (Sevoflurane)
After entering the patient's demographic data (height, gender, weight, and age), the initial target concentration (Ce) at the site of action for propofol will be recorded as 4 µg/mL in the Eleveld model (MedCaptain Eleveld HP TCI Infusion Syringe Pump), and the target concentration (Ce) for remifentanil will be recorded as 4 ng/mL in the Minto model. Ventilation will be performed with a face mask using 100% O2 after loss of consciousness and disappearance of the eyelash reflex. When the BIS value drops below 60, measurement of the degree of neuromuscular blockade (TOFWatch S monitor; Organon, Dublin, Ireland) will be initiated. Rocuronium will be administered as a bolus at a dose of 0.6 mg/kg according to ideal body weight, followed by intubation. Anesthesia maintenance will be provided with sevoflurane to keep the BIS value between 40-60. The target remifentanil concentration will be increased or decreased by 0.5 ng/mL to maintain mean arterial pressure (MAP) at 60-70 mmHg.
Drug: SEVOFLURANE
Anesthetic management will be made with sevoflurane
Active Comparator: Group T (TIVA)
After entering the patient's demographic data (height, gender, weight, and age), the Eleveld model (MedCaptain Eleveld HP TCI Infusion Syringe Pump) will be set to Ce 4 µg/mL for propofol and Ce 4 ng/mL for remifentanil in the Minto model. Ventilation with a face mask will be performed using 100% O2 after loss of consciousness and disappearance of the eyelash reflex. When the BIS value drops below 60, measurement of the degree of neuromuscular blockade (TOF - watch TOFWatch SX, Organon, Ireland) will be initiated. Rocuronium will be administered as a bolus at a dose of 0.6 mg/kg according to ideal body weight, and intubation will be performed. Anesthesia will be maintained by increasing or decreasing the target concentration of propofol by 0.5 μg/mL to keep the BIS value in the 40-60 range. The target remifentanil concentration will be increased or decreased by 0.5 ng/mL to maintain mean arterial pressure at 60-70 mmHg.
Drug: TIVA
Propofol and remifentanil will be given with TCİ device for anesthetic induction and management
Active Comparator: Group C (CIVIA)
After entering the patient's demographic data (height, gender, weight, and age), the Ce level will be set to 4 µg/mL for propofol in the Eleveld model and 4 ng/mL for remifentanil in the Minto model. Ventilation will be performed with a face mask using 100% O2 after loss of consciousness and disappearance of the eyelash reflex. When the BIS value drops below 60, measurement of the degree of neuromuscular blockade will be initiated. Rocuronium will be administered as a bolus at a dose of 0.6 mg/kg according to ideal body weight, and intubation will be performed. For maintenance of anesthesia, inhaled sevoflurane concentration will be started at 0.5 MAC, while the propofol Ce level will be adjusted to 2 µg/mL, and propofol will be increased or decreased by 0.5 μg/mL to maintain the BIS target in the 40-60 range. Remifentanil infusion will be administered to maintain mean arterial pressure at 60-70 mmHg, with a titration of 0.5 ng/mL.
Drug: CIVIA
In this group patients <0.5 MAC sevoflurane will be used in combination with total intraveous method (This method described above )

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Emergence agitation
Time Frame: Immediately after tracheal extubation
Emergence agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS). RASS is a 10-point scale ranging from +4 to -5, measures agitation, sedation level, and responsiveness.
Immediately after tracheal extubation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting (PONV)
Time Frame: Immediately post-op, 15 minutes, and 30 minutes in the Post-Anesthesia Care Unit (PACU)

Postoperative nausea and vomiting assessed on a 4-point scale:

None: 0 Mild nausea: 1 Moderate nausea: 2 Frequent vomiting: 3 Severe vomiting: 4
Immediately post-op, 15 minutes, and 30 minutes in the Post-Anesthesia Care Unit (PACU)
Extubation time
Time Frame: Immediately postoperative period
The time when patients are extubated after all anesthetic drugs have been discontinued
Immediately postoperative period
Recovery time
Time Frame: Continuous observation for 30 minutes in the PACU.
Recovery time is between the termination of anesthesia and the patient being discharged from the postoperative recovery room (PACU) with an Aldrete score of >9.
Continuous observation for 30 minutes in the PACU.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ülkü Özgül, Professor, turgut özal medical center Department of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 25, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIVIA Septoplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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