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

Sponsor
Inonu University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05601674
Collaborator
(none)
76
1
2
2.2
34.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: : Conventional flow Anesthesia
  • Other: Low Flow Anesthesia
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty: A Randomized, Controlled Trial
Actual Study Start Date :
Nov 4, 2022
Actual Primary Completion Date :
Jan 5, 2023
Anticipated Study Completion Date :
Jan 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Conventional group

Anesthesia induction will be performed with 2 mg/kg propofol, 1 µg/kg fentanyl and 0.6 mg/kg rocuronium as standard.After intubation, anesthesia will maintained with %40 O2 and sevoflurane at 2% volume. When the sevoflurane concentration reached 1 MAC, the fresh gas flow rate will be brought to 2 L/min. Inhalation anesthetics will be turned off 10 minutes before the end of the operation. The fresh gas flow will be increased to 6 l/min to be 100% O2. At the end of the surgery, the neuromuscular block will be antagonized with neostigmine-atropine. Sedation and agitation will be assessed immediately after extubation.

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

Active Comparator: Low Flow Group

anesthesia induction will be performed with 2 mg/kg propofol, 1 µg/kg fentanyl and 0.6 mg/kg rocuronium as standard.After intubation, anesthesia will maintained with %40 O2 and sevoflurane at 2% volume. When the sevoflurane concentration reached 1 MAC, the fresh gas flow rate will be brought to 0.5 L/min. Inhalation anesthetics will be turned off 10 minutes before the end of the operation. The fresh gas flow will be increased to 6 l/min to be 100% O2. At the end of the surgery, the neuromuscular block will be antagonized with neostigmine-atropine. Sedation and agitation will be assessed immediately after extubation.

Other: Low Flow Anesthesia
Fresh gas flow rate will be 0.5 L/min throughout the procedure.

Outcome Measures

Primary Outcome Measures

  1. Richmond Agitation-Sedation Scale (RASS) [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 Outcome Measures

  1. Ramsey Sedation Scale (RSS) [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ulku Ozgul Malatya Turkey 44090

Sponsors and Collaborators

  • Inonu University

Investigators

  • Principal Investigator: Ulku Ozgul, Professor, Inonu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ülkü Özgül, Professor, Inonu University
ClinicalTrials.gov Identifier:
NCT05601674
Other Study ID Numbers:
  • Low Flow Anesthesia
First Posted:
Nov 1, 2022
Last Update Posted:
Jan 6, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ülkü Özgül, Professor, Inonu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2023