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

Emergence Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601674
• Other study ID #: Low Flow Anesthesia
• Status: Completed
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: March 2023
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthetics
• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation
• Rhinoplasty

Intervention

Other:
• : Conventional flow Anesthesia
During the initial wash-in period 2 L/min Fresh gas flow will be used.
• Low Flow Anesthesia
Fresh gas flow rate will be 0.5 L/min throughout the procedure.

Locations

Country	Name	City	State
Turkey	Ulku Ozgul	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Richmond Agitation-Sedation Scale (RASS)	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)	From extubation to 30 minutes of arrival in the postoperative care unit
Secondary	Ramsey Sedation Scale (RSS)	RSS is divided into 6 levels (score range, 1-6, lower scores indicate more agitation).	From extubation to 30 minutes of arrival in the postoperative care unit
Secondary	Boezaart score	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.	immediate postoperative period
Secondary	Surgeon satisfaction	. 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.	immediate postoperative period