Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

NCT ID: NCT05751603

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2025-10-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

sugammadex is administered just after extubation.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

sugammadex is administered just after extubation

Interventions

sugammadex

sugammadex is administered just after extubation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

yun jeong chae

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

yun jeong chae, Ph D

Role: CONTACT

yjchae06@hotmail.com

+82312195689

Other Identifiers

AJOUIRB-INT-2022-173

Identifier Type: -

Identifier Source: org_study_id