Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

NCT05751603 | Not Yet Recruiting

• 1 other identifier: AJOUIRB-INT-2022-173
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Sugammadex; Extubation; Smooth Emergence

Outcome Measures

Primary Outcomes (1)

• extubation quality score

  score based on the incidence and severity of coughing straining

  immediate after extubation

Secondary Outcomes (3)

• time to respiration

  immediate after extubation

• time to extubation

  immediate after extubation

• sore throat in postanesthetic care unit

  in postanesthetic care unit

Study Arms (2)

Control group

NO INTERVENTION

Routine anesthetic process; sugammadex is administered when spontaneous respiration is returned (before extubation)

Experimental group

EXPERIMENTAL

sugammadex is administered just after extubation.

Drug: sugammadex

Interventions

sugammadex DRUG

sugammadex is administered just after extubation

Experimental group

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

yun jeong chae, Ph D

CONTACT

+82312195689; yjchae06@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: October 3, 2024
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07