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NCT Number: NCT05601674

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

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.

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Key information

Conditions

Emergence Agitation Anesthetics Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rhinoplasty Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulku Ozgul

Malatya, 44090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

: Conventional flow Anesthesia

Other

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

Low Flow Anesthesia

Other

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

Primary outcomes

  1. 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

  1. Ramsey Sedation Scale (RSS)

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

    RSS is divided into 6 levels (score range, 1-6, lower scores indicate more agitation).

  2. Boezaart score

    Time frame: immediate postoperative period

    the 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.

  3. Surgeon satisfaction

    Time frame: immediate 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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2022
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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