Clincosm LogoSign in Get a demo

Effectiveness on Smooth Extubation According to the Administration Time of Sugammadex

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05751603
Collaborator
(none)
66
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of Smooth Emergence During Extubation After Anesthesia When Sugammadex is Administered Before and After Extubation
Anticipated Study Start Date :
Apr 3, 2023
Anticipated Primary Completion Date :
Apr 3, 2024
Anticipated Study Completion Date :
Apr 3, 2024

Arms and Interventions

Arm Intervention/Treatment
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
sugammadex is administered just after extubation

Outcome Measures

Primary Outcome Measures

  1. extubation quality score [immediate after extubation]

    score based on the incidence and severity of coughing straining

Secondary Outcome Measures

  1. time to respiration [immediate after extubation]

    time from withdrawal of anesthetics to respiration

  2. time to extubation [immediate after extubation]

    time from withdrawal of anesthetics to extubation

  3. sore throat in postanesthetic care unit [in postanesthetic care unit]

    Scores obtained by questioning the patient in postanesthetic care unit

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ajou University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
yun jeong chae, professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT05751603
Other Study ID Numbers:
  • AJOUIRB-INT-2022-173
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 2, 2023