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Drug combo may banish post-surgery fatigue in gallbladder patients

NCT ID NCT07131033

Symptom relief Sponsor: The Second People's Hospital of Huai'an 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This trial tests whether giving esketamine and magnesium sulfate during gallbladder removal surgery can prevent or lessen the severe fatigue many patients feel afterward. The drugs target both brain and muscle pathways involved in post-surgery exhaustion. Researchers will compare the drugs alone and together in 120 adults aged 18 to 65 having laparoscopic cholecystectomy.

What this could mean

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

Active substance
Esketamine and magnesium sulfate
What this could lead to
If it works, this could point toward a simple, safe way to reduce fatigue and speed recovery after laparoscopic gallbladder surgery.
What could go wrong
This is an early-phase trial with only 120 people. The drugs may not reduce fatigue better than standard care, and side effects like dizziness or low blood pressure are possible.

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

128 people

The number who actually took part.

Started

Sep 2025

Finished

Jun 2026

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 to 65 years

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: * Age between 18 and 65 years * American Society of Anesthesiologists (ASA) classification I-II * body mass index (BMI) of 18.5 - 30 kg/㎡ * Patients scheduled for elective LC under general anesthesia with an anticipated surgical duration of \< 2 hours * possessing normal cognitive and communication abilities * volunteering to participate and providing written informed consent. Exclusion Criteria: * patients with severe diseases of major organs such as the heart, brain, lungs, liver, and kidneys; * patients with adverse drug reactions to esketamine or magnesium sulfate; * patients with uncontrolled hypertension or hyperthyroidism; * patients with endocrine and metabolic diseases or neurological diseases; * pregnant or lactating women; * long-term users of sedatives, analgesics, or long-term alcohol abusers; * patients with a history of mental illness, language communication barriers, or inability to understand the content of the experiment; * patients with sinus bradycardia or atrioventricular block; * patients with concurrent cholangitis, biliary obstruction, or pancreatitis. Elimination and withdrawal criteria included: * unexpected severe difficult airway during anesthesia induction necessitating alternative intubation techniques; * conversion to open laparotomy due to anatomical variations or surgical complications; * severe or refractory hemodynamic instability requiring frequent or high-dose vasoactive agents, thus precluding adherence to the study protocol; * actual surgical duration exceeding 2 hours; * loss to follow-up, voluntary withdrawal, or substantial loss of core data during the postoperative period.

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As listed by the trial registrant

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

Alleviate postoperative fatigue syndrome Laparoscopic cholecystectomy

Contacts and locations

Locations

  • The Affiliated Huaian Hospital of Xuzhou Medical University, Huai'an Second Hospital

    Huaian, China

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