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NCT Number: NCT07304206

The Effects of Three Different Anesthetic Methods on Postoperative Agitation

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.

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Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Septoplasty Surgeries Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 44250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sevoflurane

Drug

Anesthetic management will be made with sevoflurane

TIVA

Drug

Propofol and remifentanil will be given with TCİ device for anesthetic induction and management

CIVIA

Drug

In this group patients <0.5 MAC sevoflurane will be used in combination with total intraveous method (This method described above )

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Extubation time

    Time frame: Immediately postoperative period

    The time when patients are extubated after all anesthetic drugs have been discontinued

  3. 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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
May 7, 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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