ClinicalTrials.Veeva

Menu

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

I

Inonu University

Status

Completed

Conditions

Anesthetics
Emergence Agitation
Rhinoplasty

Treatments

Other: Low Flow Anesthesia
Other: : Conventional flow Anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05601674
Low Flow Anesthesia

Details and patient eligibility

About

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.

Full description

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. Hypoxia can lead to serious complications such as aspiration pneumonia, bleeding or reoperation. 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. Low flow anesthesia has many advantages; the consumption of inhalation agents is reduced, the temperature and humidity of the airways are maintained, the cost of anesthesia and pollution caused by atmospheric waste gases are reduced. In addition, because the temperature and humidity of the tracheobronchial tree are preserved, respiratory functions and mucociliary activities are better preserved. In low-flow anesthesia, the concentration of inhaled anesthetics changes very slowly, and their concentration gradually decreases after the administration is terminated. Since the anesthetic concentration will slowly decrease in the low-flow group during termination of anesthesia, the concentration difference between the brain and lungs will be small. In addition, it is known that a longer period between discontinuation of the administration of anesthetic agents and extubation reduces emergence agitation. This seems possible with the low-flow anesthesia technique.

The aim of this study is to compare the effects of low flow anesthesia and normal flow anesthesia on emergence agitation.

Enrollment

76 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18-50 years
  • ASA class I-II,
  • scheduled for elective rhinoplasty surgery under general anesthesia

Exclusion criteria

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

76 participants in 2 patient groups, including a placebo group

Conventional group
Placebo Comparator group
Description:
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.
Treatment:
Other: : Conventional flow Anesthesia
Low Flow Group
Active Comparator group
Description:
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.
Treatment:
Other: Low Flow Anesthesia

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems