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NCT Number: NCT05751603

Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

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).

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

sugammadex is administered just after extubation

Primary outcomes

  1. extubation quality score

    Time frame: immediate after extubation

    score based on the incidence and severity of coughing straining

Secondary outcomes

  1. time to respiration

    Time frame: immediate after extubation

    time from withdrawal of anesthetics to respiration

  2. time to extubation

    Time frame: immediate after extubation

    time from withdrawal of anesthetics to extubation

  3. sore throat in postanesthetic care unit

    Time frame: in postanesthetic care unit

    Scores obtained by questioning the patient in postanesthetic care unit

Study contacts

Contact information is provided by the study sponsor or research team.

yun jeong chae, Ph D

CONTACT

[email protected]

+82312195689

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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