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CompletedNCT04407078Updated Jan 8, 2021

Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female

An interventional study of Sugammadex Injectable Product and Neostigmine Injectable Product in Gallbladder Diseases, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-01-08.

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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2019, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
Female
01

Study summary

The purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female who are reversed with sugammadex or neostigmine.

Read the detailed description

Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

02

Conditions studied

  • Gallbladder Diseases

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03

In context

Gallbladder Diseases

92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.

This study's enrollment of 40 is below the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.

Browse Gallbladder Diseases studies →

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 60 Years
Sexes eligible
Female
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

  • Laparoscopic cholecystectomy under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • > 30 kg/m2, respiratory infection, uncontrolled hypertension
Terms in these criteria, in plain language(1)

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.

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 (Participant, Care provider)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Sugammadex group

    Sugammadex group receives the intravenous sugammadex of 2 mg/kg.

    Drug: Sugammadex Injectable Product

  • Placebo comparator
    Neostigmine group

    Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.

    Drug: Neostigmine Injectable Product

Interventions

  • Sugammadex of 2 mg/kg is injected.

  • DrugNeostigmine Injectable Product

    Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.

06

What researchers measure

Primary outcomes

  1. optimal Ce of remifentanil

    Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia

    Time frame: from the ene of surgery until endotracheal extubation

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
    Suwon, Gyeonggido 16499, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2019 to primary completion in Jan 2021, 13 months.

Of 32 non-industry interventional studies with no phase under Gallbladder Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 13 months is close to that.

Counting every sponsor, half of 34 studies reached it within 14 months; a quarter within 8 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
May 25, 2020
First posted
May 29, 2020
StartActual
Dec 2, 2019
Primary completionActual
Jan 6, 2021
CompletionActual
Jan 6, 2021
Last update
Jan 8, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04407078
Responsible party
Ji Eun Kim (Associate professor, Ajou University School of Medicine) — Principal investigator
First posted
May 29, 2020
Start date
Dec 2, 2019
Primary completion
Jan 6, 2021
Completion
Jan 6, 2021
Last update
Jan 8, 2021

Oversight

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

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Sugammadex

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