ClinicalTrials.gg
Not yet recruitingNCT05751603Updated Jul 25, 2024

Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

An interventional study of sugammadex in Sugammadex, Extubation and Smooth Emergence, sponsored by Ajou University School of Medicine. Not yet recruiting. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
19 Years to 64 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Sugammadex
  • Extubation
  • Smooth Emergence
03

In context

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with malformation or tumor of the upper respiratory tract
  • patients with risk of aspiration
  • obese cases with a > 35
  • patients in which tracheal intubation was difficult
  • refusal to participate in research
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • 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

Interventions

  • sugammadex is administered just after extubation

06

What researchers measure

Primary outcomes

  1. extubation quality score

    score based on the incidence and severity of coughing straining

    Time frame: immediate after extubation

Secondary outcomes

  1. time to respiration

    time from withdrawal of anesthetics to respiration

    Time frame: immediate after extubation

  2. time to extubation

    time from withdrawal of anesthetics to extubation

    Time frame: immediate after extubation

  3. sore throat in postanesthetic care unit

    Scores obtained by questioning the patient in postanesthetic care unit

    Time frame: in postanesthetic care unit

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05751603
Responsible party
yun jeong chae (professor, Ajou University School of Medicine) — Principal investigator
First posted
Mar 2, 2023
Start date
Oct 3, 2024 (estimated)
Primary completion
Oct 3, 2025 (estimated)
Completion
Oct 3, 2025 (estimated)
Last update
Jul 25, 2024

Study contacts

yun jeong chae, Ph D
Contact
yjchae06@hotmail.com
+82312195689

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Sugammadex

Start the discussion