The Effects of Three Different Anesthetic Methods on Postoperative Agitation

NCT07304206 | Enrolling By Invitation

• 1 other identifier: CIVIA Septoplasty
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation; Septoplasty Surgeries

Keywords

anesthesia; emergence agitation; tiva

Outcome Measures

Primary Outcomes (1)

• Emergence agitation

  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 Outcomes (3)

• Postoperative nausea and vomiting (PONV)

  Immediately post-op, 15 minutes, and 30 minutes in the Post-Anesthesia Care Unit (PACU)

• Extubation time

  Immediately postoperative period

• Recovery time

  Continuous observation for 30 minutes in the PACU.

Study Arms (3)

Group S (Sevoflurane)

ACTIVE COMPARATOR

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

Group T (TIVA)

ACTIVE COMPARATOR

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

Group C (CIVIA)

ACTIVE COMPARATOR

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

Interventions

SEVOFLURANE DRUG

Anesthetic management will be made with sevoflurane

Group S (Sevoflurane)

TIVA DRUG

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

Group T (TIVA)

CIVIA DRUG

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

Group C (CIVIA)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, 44250, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33588751 RESULT

MeSH Terms

Conditions

Emergence Delirium

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Ülkü Özgül, Professor

  turgut özal medical center Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 26, 2025
• Study Start: December 25, 2025
• Primary Completion: February 15, 2026
• Study Completion: April 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)