Clinical trial

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

Name
AJOUIRB-INT-2022-173
Description
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).
Trial arms
Trial start
2023-10-03
Estimated PCD
2024-10-03
Trial end
2024-10-03
Status
Not yet recruiting
Treatment
sugammadex
sugammadex is administered just after extubation
Arms:
Experimental group
Size
66
Primary endpoint
extubation quality score
immediate after extubation
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}
Updated at
2023-08-25

1 organization

1 product

3 indications

Product
sugammadex
Indication
Sugammadex
Indication
Extubation