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The Effects of Three Different Anesthetic Methods on Postoperative Agitation

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07304206
Enrollment
3
Registered
2025-12-26
Start date
2025-12-25
Completion date
2026-02-26
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation, Septoplasty Surgeries

Keywords

anesthesia, emergence agitation, tiva

Brief summary

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.

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.

Interventions

DRUGSEVOFLURANE

Anesthetic management will be made with sevoflurane

DRUGTIVA

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

DRUGCIVIA

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

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)

Masking description

Participant: The participant will be unaware of which anesthesia method is performed in the perioperative period. Care Provider: The second anesthesiologist will wake the patient after the anesthesia has been terminated and will not know which anesthesia method was used.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emergence agitationImmediately after tracheal extubationEmergence 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

MeasureTime frameDescription
Postoperative nausea and vomiting (PONV)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
Extubation timeImmediately postoperative periodThe time when patients are extubated after all anesthetic drugs have been discontinued
Recovery timeContinuous 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORÜlkü Özgül, Professor

turgut özal medical center Department of Anesthesiology and Reanimation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026