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

The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty: A Randomized, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05601674
Enrollment
76
Registered
2022-11-01
Start date
2022-11-04
Completion date
2023-03-23
Last updated
2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetics, Emergence Agitation, Rhinoplasty

Keywords

Emergence Agitation, Anesthetics

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.

Interventions

OTHER: Conventional flow Anesthesia

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

OTHERLow Flow Anesthesia

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

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Richmond Agitation-Sedation Scale (RASS)From extubation to 30 minutes of arrival in the postoperative care unitSedation 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)

Secondary

MeasureTime frameDescription
Ramsey Sedation Scale (RSS)From extubation to 30 minutes of arrival in the postoperative care unitRSS is divided into 6 levels (score range, 1-6, lower scores indicate more agitation).
Boezaart scoreimmediate postoperative periodthe quality of the operating field in terms of bleeding (Boezaart score),Participating surgeons will rate surgical site visibility from 0 to 5 on the Boezaart rating scale, where 0 is the best and 5 is the worst.
Surgeon satisfactionimmediate postoperative period. Surgeon satisfaction with the operative field will be rated at the end of surgery using a 5-choice Likert scale: 1 = very bad, 2 = bad, 3 = fair, 4 = good, and 5 = excellent.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026