The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty

NCT05601674 | Completed

• 1 other identifier: Low Flow Anesthesia
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia; this may cause respiratory depression, nausea and vomiting, as well as an increase in blood pressure, heart rate and myocardial oxygen consumption. Although its pathogenesis remains unclear, ENT (ear, nose and throat) surgical procedures have been reported to have a higher incidence of agitation in both adults and children. In recent years, low-flow inhalation anesthesia has been widely used in adult anesthesia practice. The aim of this study is to compare the effects of low flow anesthesia and normal flow anesthesia on emergence agitation.

Conditions

Emergence Agitation; Anesthetics; Rhinoplasty

Keywords

Emergence Agitation; Anesthetics

Outcome Measures

Primary Outcomes (1)

• Richmond Agitation-Sedation Scale (RASS)

  Sedation and agitation will be assessed immediately after extubation with the Richmond Agitation-Sedation Scale. RASS is divided into 10 levels (score range, -5 to 4, higher scores indicate more agitation)

  From extubation to 30 minutes of arrival in the postoperative care unit

Secondary Outcomes (3)

• Ramsey Sedation Scale (RSS)

  From extubation to 30 minutes of arrival in the postoperative care unit

• Boezaart score

  immediate postoperative period

• Surgeon satisfaction

  immediate postoperative period

Study Arms (2)

Conventional group

PLACEBO COMPARATOR

Anesthesia induction will be performed with 2 mg/kg propofol, 1 µg/kg fentanyl and 0.6 mg/kg rocuronium as standard.After intubation, anesthesia will maintained with %40 O2 and sevoflurane at 2% volume. When the sevoflurane concentration reached 1 MAC, the fresh gas flow rate will be brought to 2 L/min. Inhalation anesthetics will be turned off 10 minutes before the end of the operation. The fresh gas flow will be increased to 6 l/min to be 100% O2. At the end of the surgery, the neuromuscular block will be antagonized with neostigmine-atropine. Sedation and agitation will be assessed immediately after extubation.

Other: : Conventional flow Anesthesia

Low Flow Group

ACTIVE COMPARATOR

anesthesia induction will be performed with 2 mg/kg propofol, 1 µg/kg fentanyl and 0.6 mg/kg rocuronium as standard.After intubation, anesthesia will maintained with %40 O2 and sevoflurane at 2% volume. When the sevoflurane concentration reached 1 MAC, the fresh gas flow rate will be brought to 0.5 L/min. Inhalation anesthetics will be turned off 10 minutes before the end of the operation. The fresh gas flow will be increased to 6 l/min to be 100% O2. At the end of the surgery, the neuromuscular block will be antagonized with neostigmine-atropine. Sedation and agitation will be assessed immediately after extubation.

Other: Low Flow Anesthesia

Interventions

: Conventional flow Anesthesia OTHER

During the initial wash-in period 2 L/min Fresh gas flow will be used.

Conventional group

Low Flow Anesthesia OTHER

Fresh gas flow rate will be 0.5 L/min throughout the procedure.

Low Flow Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• ASA class I-II,
• scheduled for elective rhinoplasty surgery under general anesthesia

You may not qualify if:

• history of allergy to nonsteroidal anti-inflammatory drugs,
• bleeding diathesis or anticoagulant use,
• psychiatric drug use,
• previous rhinoplasty surgery
• patient refusal

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Ulku Ozgul

Malatya, 44090, Turkey (Türkiye)

Location

Related Publications (1)

• Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.

  PMID: 20526708 RESULT

MeSH Terms

Conditions

Emergence Delirium

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

Study Officials

• Ulku Ozgul, Professor

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: November 4, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)