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The Effects of Three Different Anesthetic Methods on Postoperative Agitation

NCT ID: NCT07304206

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2026-02-26

Brief Summary

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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

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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.

Conditions

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Emergence Agitation Septoplasty Surgeries

Keywords

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anesthesia emergence agitation tiva

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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Group S (Sevoflurane)

In the sevoflurane group (Group S), anesthesia will be induced with 2 mg/kg propofol, 1 µg/kg fentanyl, and 0.6 mg/kg rocuronium. The sevoflurane concentration will be adjusted to maintain a BIS of 40-60. Patients will breathe with a mixture of 60% air and 40% O2, with a fresh gas flow of 1 L/min. An intravenous infusion of 0.05-0.2 µg/kg/min remifentanil will be administered as an analgesic, maintaining a mean arterial blood pressure (MAP) of 60-70 mmHg.

Group Type ACTIVE_COMPARATOR

SEVOFLURANE

Intervention Type DRUG

Anesthetic management will be made with sevoflurane

Group T (TIVA)

In the TIVA (total intravenous anesthesia) group (Group T), propofol and remifentanil will be administered using the TCI for anesthesia induction, achieving an effect site concentration (Ce) of 4 µg each in the eleveld model. Patients will be intubated after muscle relaxation is achieved with 0.6 mg/kg rocuronium. For maintenance of anesthesia, the propofol dose will be adjusted with incremental titrations of 0.5 µg/mL to achieve a BIS value of 40-60, while the remifentanil infusion will be adjusted to achieve an effect site concentration (Ce) of 60-70 mmHg in the elevated model by reducing the effect site concentration (Ce) to 2 µg. They will breathe with a mixture of 60% air and 40% O2, with a fresh gas flow of 1 L/min.

Group Type ACTIVE_COMPARATOR

TIVA

Intervention Type DRUG

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

Group C (CIVIA)

In the combined inhalation-intravenous group (Group C), anesthesia induction will be performed using the TCI in the eleveld model with propofol and remifentanil at a Ce concentration of 4 µg each. After muscle relaxation is achieved with 0.6 mg/kg rocuronium, patients will be intubated. For maintenance, sevoflurane will be adjusted to 0.5 MAC, while the propofol dose will be titrated in 0.5 µg/mL increments to achieve a BIS value of 40-60. As an analgesic, remifentanil will be adjusted to achieve an effect site concentration (Ce) of 2 µg in the eleveld model, and MAP will be adjusted to 60-70 mmHg. Ventilation will be provided with a mixture of 60% air and 40% O2, with a fresh gas flow of 1 L/min.

Group Type ACTIVE_COMPARATOR

CIVIA

Intervention Type DRUG

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

Interventions

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SEVOFLURANE

Anesthetic management will be made with sevoflurane

Intervention Type DRUG

TIVA

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

Intervention Type DRUG

CIVIA

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Ülkü Özgül

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ülkü Özgül, Professor

Role: STUDY_DIRECTOR

turgut özal medical center Department of Anesthesiology and Reanimation

Locations

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Inonu University

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Wolf A, Selpien H, Haberl H, Unterberg M. Does a combined intravenous-volatile anesthesia offer advantages compared to an intravenous or volatile anesthesia alone: a systematic review and meta-analysis. BMC Anesthesiol. 2021 Feb 15;21(1):52. doi: 10.1186/s12871-021-01273-1.

Reference Type RESULT
PMID: 33588751 (View on PubMed)

Other Identifiers

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CIVIA Septoplasty

Identifier Type: -

Identifier Source: org_study_id