Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

Extubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05751603
• Other study ID #: AJOUIRB-INT-2022-173
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: October 3, 2024

Study information

• Verified date: August 2023
• Source: Ajou University School of Medicine
• Contact: yun jeong chae, Ph D
• Phone: +82312195689
• Email: yjchae06[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: October 3, 2024
• Est. primary completion date: October 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Extubation
• Sugammadex

Intervention

Drug:
• sugammadex
sugammadex is administered just after extubation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	extubation quality score	score based on the incidence and severity of coughing straining	immediate after extubation
Secondary	time to respiration	time from withdrawal of anesthetics to respiration	immediate after extubation
Secondary	time to extubation	time from withdrawal of anesthetics to extubation	immediate after extubation
Secondary	sore throat in postanesthetic care unit	Scores obtained by questioning the patient in postanesthetic care unit	in postanesthetic care unit