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Clinical Trials/NCT05601674
NCT05601674
Completed
Not Applicable

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

Inonu University1 site in 1 country76 target enrollmentNovember 4, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergence Agitation
Sponsor
Inonu University
Enrollment
76
Locations
1
Primary Endpoint
Richmond Agitation-Sedation Scale (RASS)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 4, 2022
End Date
March 23, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ülkü Özgül

Professor

Inonu University

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

Outcomes

Primary Outcomes

Richmond Agitation-Sedation Scale (RASS)

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

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)

Secondary Outcomes

  • Surgeon satisfaction(immediate postoperative period)
  • Ramsey Sedation Scale (RSS)(From extubation to 30 minutes of arrival in the postoperative care unit)
  • Boezaart score(immediate postoperative period)

Study Sites (1)

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