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Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

A

Ajou University School of Medicine

Status

Not yet enrolling

Conditions

Sugammadex
Smooth Emergence
Extubation

Treatments

Drug: sugammadex

Study type

Interventional

Funder types

Other

Identifiers

NCT05751603
AJOUIRB-INT-2022-173

Details and patient eligibility

About

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).

Enrollment

66 estimated patients

Sex

All

Ages

19 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups

Control group
No Intervention group
Description:
Routine anesthetic process; sugammadex is administered when spontaneous respiration is returned (before extubation)
Experimental group
Experimental group
Description:
sugammadex is administered just after extubation.
Treatment:
Drug: sugammadex

Trial contacts and locations

0

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Central trial contact

yun jeong chae, Ph D

Data sourced from clinicaltrials.gov

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