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Can a nociception monitor cut opioid use in Day-Surgery gallbladder removal?

NCT ID NCT07810894

Symptom relief Sponsor: Svendborg Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

Researchers are testing whether a nociception level monitor can guide remifentanil dosing during laparoscopic gallbladder removal, a common day surgery. The monitor scores the body's response to surgical stimulation on a 0 to 100 scale. In this trial, 120 adults are randomly assigned to have remifentanil adjusted either by the monitor or by standard clinical signs. The team measures morphine use in the recovery room and recovery quality afterward.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remifentanil, a short-acting opioid painkiller, dosed with help from a nociception level monitor
What this could lead to
If it works, the monitor could help anesthesiologists give just enough opioid during surgery, which may mean less painkiller needed afterward and a faster return home after day surgery.
What could go wrong
This is a single-center study of 120 people having one type of operation, so the approach may not help everyone or work the same way elsewhere. Monitor-guided dosing can also be affected by other drugs and patient factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Dec 2023

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * American Society of Anesthesiologists (ASA) class I-III * Patients aged 18 years + * Non-pregnant * Must read and understand Danish * Scheduled for ambulatory elective laparoscopic cholecystectomy Exclusion Criteria: * Inability to give consent * Regular opioid use * Chronic kidney disease (eGFR\<30) * Intolerance to opioids, and surgery converted to open procedure.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Elective laparoscopic cholecystectomy Use of morphine in the postanasthesia care unit after laparoscopic cholecystectomy

Contacts and locations

Locations

  • Odense University Hospital Svendborg

    Svendborg, Region Syddanmark, 5700, Denmark

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