ClinicalTrials.gg
CompletedNCT03292965Updated Oct 9, 2018

Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

An interventional study of Neostigmine and Sugammadex in Neuromuscular Block, Residual, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies testing sugammadex in Delayed Emergence from Anesthesia — 2 open to participants now, 2 under way, none of them phase 3. Sugammadex · Delayed Emergence from Anesthesia.

Enrollment
9th of 14
80 · median 92
Started
2017
the only one that year
No phase
6 of 14
1 open now
Registered
3rd of 14
by date
Lead sponsor
1 of 14
Seoul National University Bundang Hospital

Among the 14 studies testing sugammadex in Delayed Emergence from Anesthesia, this one is the 9th largest by enrollment, is the only one that started in 2017, is one of 6 with no phase, and was the 3rd registered.

Delayed Emergence from Anesthesia

98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.

Browse Delayed Emergence from Anesthesia studies →

Open to participants now

2 of the 14 studies testing sugammadex in Delayed Emergence from Anesthesia are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About sugammadex

Sugammadex: first FDA approval 2015 (BRIDION), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 8 Delayed Emergence from Anesthesia studies recruiting now, 2 (25%) set no upper age limit and 4 (50%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring

Read the detailed description

At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio > 0.9 between the neostigmine group and sugammadex group.

03

Conditions studied

  • Neuromuscular Block, Residual
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

  • patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Obesity over 30 kg/m2
  • Impairment of renal or/and liver function
  • Allergy to rocuronium, sugammadex
  • (Familial) history of malignant hyperthermia
  • Taking medicines which is affecting neuromuscular function
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
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Neostigmine

    At the end of surgery, administrating neostigmine to participants according to the protocol below: when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg

    Drug: Neostigmine

  • Active comparator
    Sugammadex

    At the end of surgery, administrating sugammadex to participants according to the protocol below: when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg

    Drug: Sugammadex

Interventions

  • Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal

  • Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal

    Also known as: Bridion

06

What researchers measure

Primary outcomes

  1. the incidence of postoperative residual curarization

    definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9

    Time frame: Immediately after entering PACU

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
08

References and documents

Publications

  • Lee YJ, Oh AY, Koo BW, Han JW, Park JH, Hong JP, Seo KS. Postoperative residual neuromuscular blockade after reversal based on a qualitative peripheral nerve stimulator response: A randomised controlled trial. Eur J Anaesthesiol. 2020 Mar;37(3):196-202. doi: 10.1097/EJA.0000000000001157. PubMed 31977627 ↗

Individual participant data

Plan to share: Undecided

09

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 Sep 2017 to primary completion in Nov 2017, 2 months.

Of 20 interventional studies with no phase under Delayed Emergence from Anesthesia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 17. This study's 2 months is below that.

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

Registered
Sep 21, 2017
First posted
Sep 26, 2017
StartActual
Sep 28, 2017
Primary completionActual
Nov 29, 2017
CompletionActual
Nov 29, 2017
Last update
Oct 9, 2018
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 Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03292965
Responsible party
LEE YEA JI (clinical professor of department of anesthesiology and pain medicine, Seoul National University Bundang Hospital) — Principal investigator
First posted
Sep 26, 2017
Start date
Sep 28, 2017
Primary completion
Nov 29, 2017
Completion
Nov 29, 2017
Last update
Oct 9, 2018

Study contacts

AhYoung Oh, M.D Ph. D
study chair · Department of anesthesiology and pain medicine

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Neostigmine · Sugammadex

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