Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

Comparison of Smooth Emergence During Extubation After Anesthesia When Sugammadex is Administered Before and After Extubation

After surgery is completed under general anesthesia, extubation is performed after recovery from anesthesia, and during this process, bucking, coughing, and rapid and excessive hemodynamic fluctuations occur very often. These phenomena can lead to high intrathoracic pressure, venous congestion, hematoma formation, or increased bleeding after major neck surgery. (1) They can also increase the risk of aerosol generation, which can transmit infection to health care workers. (2) For this, smooth extubation is required. Methods of administering drugs such as lidocaine, opioids, or dexmedetomidine have been proposed for smooth extubation. (3-5) As a disadvantage, the use of these drugs may be associated with deep sedation and reduced airway reflexes .

Recently, Babu et al. (6) reported that bucking and coughing during extubation could be reduced by changing the timing of administering a muscle relaxant antagonist rather than using these sedative drugs, and thus complications related to extubation could be reduced. In general, in the awakening process, it was common to administer the muscle relaxant at the point of recovery of spontaneous breathing. However, Babu et al. demonstrated the possibility of safe and smooth extubation by changing the timing of administering neostigmine without the use of sedatives or narcotic analgesics, but there are few studies on sugammadex.

Therefore, when recovering from general anesthesia, sugammadex was administered before and immediately after extubation to evaluate and compare smooth extubation (ie, comparison of the frequency of bucking and coughing).

Study Overview

• Status: Not yet recruiting
• Conditions: Extubation; Sugammadex; Smooth Emergence
• Intervention / Treatment: Drug: sugammadex

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yun jeong chae, Ph D; Phone Number: +82312195689; Email: yjchae06@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients undergoing general anesthesia for thyroid surgery.
• aged between 19 and 64 years
• American Society of Anesthesiologists physical status I and II

Exclusion Criteria:

• patients with malformation or tumor of the upper respiratory tract
• patients with risk of aspiration
• obese cases with a BMI > 35
• patients in which tracheal intubation was difficult
• refusal to participate in research

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Routine anesthetic process; sugammadex is administered when spontaneous respiration is returned (before extubation)
Experimental: Experimental group; sugammadex is administered just after extubation.	Drug: sugammadex; sugammadex is administered just after extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
extubation quality score	score based on the incidence and severity of coughing straining	immediate after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to respiration	time from withdrawal of anesthetics to respiration	immediate after extubation
time to extubation	time from withdrawal of anesthetics to extubation	immediate after extubation
sore throat in postanesthetic care unit	Scores obtained by questioning the patient in postanesthetic care unit	in postanesthetic care unit

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): October 3, 2024
• Primary Completion (Estimated): October 3, 2025
• Study Completion (Estimated): October 3, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AJOUIRB-INT-2022-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No