Clinical trial NCT05601674: The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty
Official title: The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Agitation
Anesthetics
Rhinoplasty
Keywords: Emergence Agitation
Anesthetics
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: From extubation to 30 minutes of arrival in the postoperative care unit
Secondary outcomes:
measure: Ramsey Sedation Scale (RSS)
timeFrame: From extubation to 30 minutes of arrival in the postoperative care unit
measure: Boezaart score
timeFrame: immediate postoperative period
measure: Surgeon satisfaction
timeFrame: immediate postoperative period
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Ulku Ozgul
Study officials:
affiliation: Inonu University
name: Ulku Ozgul, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.