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

March 23, 2023 updated by: Ülkü Özgül, Inonu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 44090
        • Ulku Ozgul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From extubation to 30 minutes of arrival in the postoperative care unit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From extubation to 30 minutes of arrival in the postoperative care unit
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.
immediate postoperative period
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.
immediate postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Principal Investigator: Ulku Ozgul, Professor, Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2022

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Low Flow Anesthesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Emergence Agitation

Clinical Trials on : Conventional flow Anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe