Laparoscopic CholecystectomyNCT07131033

Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy

A study testing Esketamine, Magnesium sulfate and Esketamine and Magnesium sulfate in people with Laparoscopic Cholecystectomy and Alleviate Postoperative Fatigue Syndrome, run by The Second People's Hospital of Huai'an at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Laparoscopic Cholecystectomy, Alleviate Postoperative Fatigue Syndrome
What is being tested?: Esketamine, Magnesium sulfate and Esketamine and Magnesium sulfate
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: 1 siteChina
Study dates: 1 Sep 2025to 1 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: Effects of Perioperative Intravenous Infusion Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy: A 2×2 Factorial Randomized Controlled Trial

Laparoscopic cholecystectomy (LC), although minimally invasive, is frequently associated with postoperative fatigue syndrome (POFS), which can delay recovery and prolong convalescence. Esketamine, an NMDA receptor antagonist, has demonstrated potential benefits in reducing postoperative fatigue and pain through central sensitization blockade and anti-inflammatory effects. Magnesium sulfate, another NMDA receptor antagonist and physiological calcium channel blocker, offers complementary analgesic, anti-inflammatory, and cardiovascular-modulating properties. This randomized, double-blind, 2 × 2 factorial trial aims to evaluate the independent and combined effects of perioperative esketamine and magnesium sulfate on postoperative fatigue, recovery quality, pain, and intraoperative hemodynamics in patients undergoing LC, with the goal of identifying an effective and safe strategy to accelerate early postoperative rehabilitation.

Read the detailed description

This randomized, double-blind trial investigated the effects of esketamine and magnesium sulfate on postoperative fatigue syndrome in patients undergoing laparoscopic cholecystectomy. Using computer-generated randomization and sealed envelopes, 128 patients were allocated in a 1:1:1:1 ratio to four groups: Group E received intravenous esketamine (0.25 mg/kg over 10 min pre-induction followed by 0.125 mg/kg/h); Group M received magnesium sulfate (30 mg/kg over 10 min pre-induction followed by 10 mg/kg/h); Group EM received both drugs concurrently at the specified doses; and Group C received volume-matched normal saline. Patients, attending anesthesiologists, and outcome assessors remained blinded to group assignment throughout the study, with intraoperative management handled by a separate non-investigating anesthesiologist to preserve blinding integrity.

The patients were routinely fasted for 8 h and abstained from drinking for 2 h preoperatively. No premedication was administered. After admission, patients were routinely administered oxygen by mask, peripheral venous access was opened, and standard monitoring was applied, including noninvasive blood pressure, pulse oximetry, electrocardiogram, body temperature, and bispectral index (BIS). Additionally, a noninvasive hemodynamic monitoring system (NICAP-T20A, Mailian Medical Technology Co., Ltd., Changsha, China) was used to continuously record cardiac output (CO) and systemic vascular resistance (SVR). Anesthesia was induced with propofol 1.5 to 2.0 mg/kg, sufentanil 0.5 μg/kg, and rocuronium bromide 0.6 mg/kg. Subsequently, 4 mg of intravenous betamethasone was administered. Following 3 minutes of mask ventilation, tracheal intubation was performed. Mechanical ventilation was controlled using an oxygen-air mixture (flow rate, 2.0 L/min; FiO₂, 50%) with a tidal volume of 6 to 8 mL/kg and an inspiratory-to-expiratory ratio of 1:2. End-tidal carbon dioxide was maintained at 35 to 40 mmHg. During anesthesia maintenance, remifentanil 0.1 to 0.5 μg/kg/min and propofol 4 to 12 mg/kg/h were continuously infused in all four groups. A four-channel microinfusion pump was used for synchronous intravenous infusion. Each drug was administered through an independent channel to avoid drug interactions, and the study drugs were continuously infused during the operation until the end of surgery. The appropriate depth of anesthesia (BIS 40-60) was maintained by adjusting the infusion rate of propofol and remifentanil. Vasoactive drugs (ephedrine, phenylephrine) were administered as needed to regulate blood pressure. After the operation, the patient was immediately transferred to the PACU. The trachea was extubated upon the recovery of consciousness, adequate muscle strength, and stable spontaneous respiration. Patients were discharged to the ward if no adverse events occurred during a 30-minute observation period and the Steward recovery score was ≥ 4. In the PACU, 30 mg of ketorolac tromethamine was administered intravenously for analgesia if the patient's NRS score was > 3 or if the patient requested analgesia.

Conditions: Laparoscopic Cholecystectomy, Alleviate Postoperative Fatigue Syndrome
Being tested: Esketamine, Magnesium sulfate, Esketamine and Magnesium sulfate, Saline
Keywords: esketamine, magnesium sulfate, postoperative fatigue syndrome, Laparoscopic Cholecystectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EsketamineDrug
Patients were given intravenous esketamine 0.25 mg/kg 10 min before induction of anaesthesia, followed by continuous pumping at 0.125 mg/(kg-h) until the end of the operation.
Magnesium sulfateDrug
Patients were injected with 30 mg/kg of magnesium sulphate intravenously 10 min before the induction of anaesthesia, followed by continuous pumping at 10 mg/(kg-h) until the end of the operation.
Esketamine and Magnesium sulfateDrug
Patients received a simultaneous intravenous infusion of esketamine (0.25 mg/kg) and magnesium sulfate (30 mg/kg) over 10 minutes before anesthesia induction, followed by continuous infusion of esketamine at 0.125 mg/kg/h and magnesium sulfate at 10 mg/kg/h via separate channels until surgery completion.
SalineDrug
Patients in the control group received an equivalent volume of normal saline infused intravenously over 10 minutes before anesthesia induction, followed by continuous saline infusion at a matched flow rate via a separate channel until surgery completion.

Study groups in NCT07131033
Study group	Role	What they receive
Esketamine	Experimental	Patients were given intravenous esketamine 0.25 mg/kg 10 min before induction of anaesthesia, followed by continuous pumping at 0.125 mg/(kg-h) until the end of the operation. Receives: Drug: Esketamine
Magnesium Sulfate	Experimental	Patients were injected with 30 mg/kg of magnesium sulphate intravenously 10 min before the induction of anaesthesia, followed by continuous pumping at 10 mg/(kg-h) until the end of the operation. Receives: Drug: Magnesium sulfate
Esketamine and Magnesium Sulfate	Experimental	Patients received a simultaneous intravenous infusion of esketamine (0.25 mg/kg) and magnesium sulfate (30 mg/kg) over 10 minutes before anesthesia induction, followed by continuous infusion of esketamine at 0.125 mg/kg/h and magnesium sulfate at 10 mg/kg/h via separate channels until surgery completion. Receives: Drug: Esketamine and Magnesium sulfate
Control	Placebo comparator	Patients in the control group received an equivalent volume of normal saline infused intravenously over 10 minutes before anesthesia induction, followed by continuous saline infusion at a matched flow rate via a separate channel until surgery completion. Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Christensen's Fatigue Scale
The Christensen Fatigue Scale, a widely used unidimensional tool for assessing postoperative fatigue syndrome, relies on patients' subjective ratings of fatigue and daily activity ability on a 1-10 scale, with no multiple subdimensions or specific items. Scoring criteria are: 1-2 points (normal, fatigue only with excessive activity, normal sleep); 3-5 points (able to perform daily activities, occasional slightly strenuous activity); 6-8 points (maintaining only partial daily activities, difficulty with walking/climbing stairs, need for sleep); 9-10 points (unable to perform daily activities, extreme need for sleep). A score > 2 points indicates fatigue, while ≥ 6 points may signal clinically noticeable postoperative fatigue syndrome.
Measured: postoperative day 1 (POD1)

Secondary outcomes (9)

Christensen's Fatigue Scale
The Christensen Fatigue Scale, a widely used unidimensional tool for assessing postoperative fatigue syndrome, relies on patients' subjective ratings of fatigue and daily activity ability on a 1-10 scale, with no multiple subdimensions or specific items. Scoring criteria are: 1-2 points (normal, fatigue only with excessive activity, normal sleep); 3-5 points (able to perform daily activities, occasional slightly strenuous activity); 6-8 points (maintaining only partial daily activities, difficulty with walking/climbing stairs, need for sleep); 9-10 points (unable to perform daily activities, extreme need for sleep). A score > 2 points indicates fatigue, while ≥ 6 points may signal clinically noticeable postoperative fatigue syndrome.
Measured: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)
Identity-Consequence Fatigue Scale
The 31-item Identity-Consequence Fatigue Scale (ICFS), which is a multidimensional self-report questionnaire designed to comprehensively assess fatigue, captures fatigue's complexity by exploring its interactions with one's sense of identity and consequent impacts on daily functioning, emotional states, and social interactions. For scoring, items typically use Likert-type scales (with slight variations in response options across items), some requiring reverse scoring for consistent interpretation. Total scores are summed, with the minimum and maximum values of the total score to be specified based on the scale's scoring criteria; higher scores indicate more severe (worse) fatigue. This comprehensive 31-item structure enables detailed exploration of fatigue, suiting research needing a thorough understanding of its multifaceted nature.
Measured: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)
The Quality of Recovery-15（QoR-15）
The QoR-15 scale is divided into five dimensions: physical comfort (5 items), self-care (2 items), psychological support (2 items), emotional state (4 items), and pain (2 items), with each item rated on a scale of 0-10, and the total score ranging from 0-150, with the higher the score the better the quality of recovery, and a score of 118 and above indicating surgery.
Measured: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)
Numeric Rating Scale（NRS）
NRS is a rating used to assess a patient's level of pain, which is assessed by the patient based on self-perception on a scale from 0 to 10. A score of 0 represents no pain and a score of 10 represents the most pain.
Measured: 5 minutes after extubation, postoperative day 1 (POD1), postoperative day 2 (POD2)
Richmond Agitation and Sedation Scale(RASS)
The Richmond Agitation-Sedation Scale (RASS) is a widely used tool to assess the level of sedation and agitation in patients. It ranges from +4 to -5, with specific descriptors for each score: +4 indicates combative behavior; +3 is extremely agitated; +2 means agitated and restless ; +1 denotes restless but calm; 0 represents alert and calm; -1 is drowsy; -2 indicates light sedation; -3 means moderate sedation; -4 is deep sedation ; and -5 represents unarousable. This scale helps clinicians objectively evaluate and adjust sedation levels to ensure patient comfort and safety.
Measured: 5 minutes after extubation, postoperative day 1 (POD1), postoperative day 2 (POD2)
perioperative hemodynamic fluctuations
Mean arterial blood pressure (MAP); Heart Rate (HR); CardiacOutput (CO); Systemic Vascular Resistance (SVR)
Measured: At seven predefined time points: upon operating room arrival (T0), post-induction (T1), post-intubation (T2), at skin incision (T3), immediately after pneumoperitoneum establishment (T4), 10 minutes post-pneumoperitoneum (T5), and at the end of surgery (
Discontinuation time, extubation time
Patient awakening time and extubation time (time from stopping medication to awakening and extubation)
Measured: Postoperative
Drug use
The names and dosages of the patients' intraoperative anaesthetic drugs (propofol and remifentanil), vasoactive drugs, and postoperative analgesic drugs were recorded.
Measured: Perioperative
Incidence of adverse reactions
respiratory depression, postoperative coughing, incidence of postoperative nausea and vomiting, postoperative hoarseness, sore throat, hallucinations, drowsiness, nightmares, blurred vision, sensory abnormalities, dissociative symptoms, cognitive decline, muscle strength reduction
Measured: postoperative day 1 (POD1), postoperative day 2 (POD2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20251 Jun 2026

First posted19 Aug 2025
Study start1 Sep 2025
Primary completion1 Jun 2026
Study completion1 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07131033
Sponsor's protocol ID: CLanXie
Status last verified: Sep 2026
First submitted: 13 Aug 2025
Last updated: 10 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lacourt TE, Vichaya EG, Chiu GS, Dantzer R, Heijnen CJ. The High Costs of Low-Grade Inflammation: Persistent Fatigue as a Consequence of Reduced Cellular-Energy Availability and Non-adaptive Energy Expenditure. Front Behav Neurosci. 2018 Apr 26;12:78. doi: 10.3389/fnbeh.2018.00078. eCollection 2018.
PubMed 29755330
Zargar-Shoshtari K, Hill AG. Postoperative fatigue: a review. World J Surg. 2009 Apr;33(4):738-45. doi: 10.1007/s00268-008-9906-0.
PubMed 19189174
Zhuang CL, Mao XY, Liu S, Chen WZ, Huang DD, Zhang CJ, Chen BC, Shen X, Yu Z. Ginsenoside Rb1 improves postoperative fatigue syndrome by reducing skeletal muscle oxidative stress through activation of the PI3K/Akt/Nrf2 pathway in aged rats. Eur J Pharmacol. 2014 Oct 5;740:480-7. doi: 10.1016/j.ejphar.2014.06.040. Epub 2014 Jun 27.
PubMed 24975098
Chen W, Liu S, Chen F, Zhou C, Zhuang C, Shao S, Yu J, Huang D, Chen B, Yu Z. [Relationship between NMDA receptor and postoperative fatigue syndrome and its associated central mechanism]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Apr;18(4):376-81. Chinese.
PubMed 25940183
Wang X, Lin C, Lan L, Liu J. Perioperative intravenous S-ketamine for acute postoperative pain in adults: A systematic review and meta-analysis. J Clin Anesth. 2021 Feb;68:110071. doi: 10.1016/j.jclinane.2020.110071. Epub 2020 Oct 26.
PubMed 33007645
Lin X, Feng X, Sun L, Wang Y, Wu X, Lu S, Shao L, Wang W, Yang L, Geng W, Lin H. Effects of esketamine on postoperative fatigue syndrome in patients after laparoscopic resection of gastric carcinoma: a randomized controlled trial. BMC Anesthesiol. 2024 May 24;24(1):185. doi: 10.1186/s12871-024-02513-w.
PubMed 38789968
Sun L, Zhao Y, Li Y, Zhai W, Gao F, Yin Q, Cheng W, Wang Z, Zeng Y. Effect of continuous subanesthetic esketamine infusion on postoperative fatigue in patients undergoing laparoscopic radical resection for colorectal cancer: a randomized controlled study. Am J Cancer Res. 2023 Jun 15;13(6):2554-2563. eCollection 2023.
PubMed 37424809
De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
PubMed 23669270
Fritzen R, Davies A, Veenhuizen M, Campbell M, Pitt SJ, Ajjan RA, Stewart AJ. Magnesium Deficiency and Cardiometabolic Disease. Nutrients. 2023 May 17;15(10):2355. doi: 10.3390/nu15102355.
PubMed 37242238
Zhou J, Liu Q, Wang L, Shen L, Zheng W, Xie C. Effects of Esketamine and Magnesium Sulfate on Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized, Double-Blind, Placebo-Controlled, 2x2 Factorial Trial. J Pain Res. 2026 Oct 17;19:636898. doi: 10.2147/JPR.S636898. eCollection 2026.
PubMed 42909966

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Laparoscopic Cholecystectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Perioperative Intravenous Infusion Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy: A 2×2 Factorial Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07131033
Acronym / sponsor ID: CLanXie
Conditions: Laparoscopic Cholecystectomy, Alleviate Postoperative Fatigue Syndrome
Keywords: esketamine, magnesium sulfate, postoperative fatigue syndrome, Laparoscopic Cholecystectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: The Second People's Hospital of Huai'anUniversity, hospital or other
Study start: 1 Sep 2025 (actual)
Primary completion: 1 Jun 2026 (actual)
Study completion: 1 Jun 2026 (actual)
First posted: 19 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Esketamine	Experimental	Drug: EsketaminePatients were given intravenous esketamine 0.25 mg/kg 10 min before induction of anaesthesia, followed by continuous pumping at 0.125 mg/(kg-h) until the end of the operation.
Magnesium Sulfate	Experimental	Drug: Magnesium sulfatePatients were injected with 30 mg/kg of magnesium sulphate intravenously 10 min before the induction of anaesthesia, followed by continuous pumping at 10 mg/(kg-h) until the end of the operation.
Esketamine and Magnesium Sulfate	Experimental	Drug: Esketamine and Magnesium sulfatePatients received a simultaneous intravenous infusion of esketamine (0.25 mg/kg) and magnesium sulfate (30 mg/kg) over 10 minutes before anesthesia induction, followed by continuous infusion of esketamine at 0.125 mg/kg/h and magnesium sulfate at 10 mg/kg/h via separate channels until surgery completion.
Control	Placebo comparator	Drug: SalinePatients in the control group received an equivalent volume of normal saline infused intravenously over 10 minutes before anesthesia induction, followed by continuous saline infusion at a matched flow rate via a separate channel until surgery completion.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EsketaminePatients were given intravenous esketamine 0.25 mg/kg 10 min before induction of anaesthesia, followed by continuous pumping at 0.125 mg/(kg-h) until the end of the operation.	Drug	Esketamine
Magnesium sulfatePatients were injected with 30 mg/kg of magnesium sulphate intravenously 10 min before the induction of anaesthesia, followed by continuous pumping at 10 mg/(kg-h) until the end of the operation.	Drug	Magnesium Sulfate
Esketamine and Magnesium sulfatePatients received a simultaneous intravenous infusion of esketamine (0.25 mg/kg) and magnesium sulfate (30 mg/kg) over 10 minutes before anesthesia induction, followed by continuous infusion of esketamine at 0.125 mg/kg/h and magnesium sulfate at 10 mg/kg/h via separate channels until surgery completion.	Drug	Esketamine and Magnesium Sulfate
SalinePatients in the control group received an equivalent volume of normal saline infused intravenously over 10 minutes before anesthesia induction, followed by continuous saline infusion at a matched flow rate via a separate channel until surgery completion.	Drug	Control

Primary outcome

Christensen's Fatigue Scale
Time frame: postoperative day 1 (POD1)
The Christensen Fatigue Scale, a widely used unidimensional tool for assessing postoperative fatigue syndrome, relies on patients' subjective ratings of fatigue and daily activity ability on a 1-10 scale, with no multiple subdimensions or specific items. Scoring criteria are: 1-2 points (normal, fatigue only with excessive activity, normal sleep); 3-5 points (able to perform daily activities, occasional slightly strenuous activity); 6-8 points (maintaining only partial daily activities, difficulty with walking/climbing stairs, need for sleep); 9-10 points (unable to perform daily activities, extreme need for sleep). A score > 2 points indicates fatigue, while ≥ 6 points may signal clinically noticeable postoperative fatigue syndrome.

9 secondary outcomes

Christensen's Fatigue Scale
Time frame: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)
Identity-Consequence Fatigue Scale
Time frame: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)
The Quality of Recovery-15（QoR-15）
Time frame: Preoperative day 1 (PRE1), postoperative day 1 (POD1), postoperative day 2 (POD2), postoperative day 7 (POD7), postoperative day 30 (POD30)
Numeric Rating Scale（NRS）
Time frame: 5 minutes after extubation, postoperative day 1 (POD1), postoperative day 2 (POD2)
Richmond Agitation and Sedation Scale(RASS)
Time frame: 5 minutes after extubation, postoperative day 1 (POD1), postoperative day 2 (POD2)
perioperative hemodynamic fluctuations
Time frame: At seven predefined time points: upon operating room arrival (T0), post-induction (T1), post-intubation (T2), at skin incision (T3), immediately after pneumoperitoneum establishment (T4), 10 minutes post-pneumoperitoneum (T5), and at the end of surgery (
Discontinuation time, extubation time
Time frame: Postoperative
Drug use
Time frame: Perioperative
Incidence of adverse reactions
Time frame: postoperative day 1 (POD1), postoperative day 2 (POD2)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Background: PubMed 29755330Lacourt TE, Vichaya EG, Chiu GS, Dantzer R, Heijnen CJ. The High Costs of Low-Grade Inflammation: Persistent Fatigue as a Consequence of Reduced Cellular-Energy Availability and Non-adaptive Energy Expenditure. Front Behav Neurosci. 2018 Apr 26;12:78. doi: 10.3389/fnbeh.2018.00078. eCollection 2018.
Background: PubMed 19189174Zargar-Shoshtari K, Hill AG. Postoperative fatigue: a review. World J Surg. 2009 Apr;33(4):738-45. doi: 10.1007/s00268-008-9906-0.
Background: PubMed 24975098Zhuang CL, Mao XY, Liu S, Chen WZ, Huang DD, Zhang CJ, Chen BC, Shen X, Yu Z. Ginsenoside Rb1 improves postoperative fatigue syndrome by reducing skeletal muscle oxidative stress through activation of the PI3K/Akt/Nrf2 pathway in aged rats. Eur J Pharmacol. 2014 Oct 5;740:480-7. doi: 10.1016/j.ejphar.2014.06.040. Epub 2014 Jun 27.
Background: PubMed 25940183Chen W, Liu S, Chen F, Zhou C, Zhuang C, Shao S, Yu J, Huang D, Chen B, Yu Z. [Relationship between NMDA receptor and postoperative fatigue syndrome and its associated central mechanism]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Apr;18(4):376-81. Chinese.
Background: PubMed 33007645Wang X, Lin C, Lan L, Liu J. Perioperative intravenous S-ketamine for acute postoperative pain in adults: A systematic review and meta-analysis. J Clin Anesth. 2021 Feb;68:110071. doi: 10.1016/j.jclinane.2020.110071. Epub 2020 Oct 26.
Background: PubMed 38789968Lin X, Feng X, Sun L, Wang Y, Wu X, Lu S, Shao L, Wang W, Yang L, Geng W, Lin H. Effects of esketamine on postoperative fatigue syndrome in patients after laparoscopic resection of gastric carcinoma: a randomized controlled trial. BMC Anesthesiol. 2024 May 24;24(1):185. doi: 10.1186/s12871-024-02513-w.
Background: PubMed 37424809Sun L, Zhao Y, Li Y, Zhai W, Gao F, Yin Q, Cheng W, Wang Z, Zeng Y. Effect of continuous subanesthetic esketamine infusion on postoperative fatigue in patients undergoing laparoscopic radical resection for colorectal cancer: a randomized controlled study. Am J Cancer Res. 2023 Jun 15;13(6):2554-2563. eCollection 2023.
Background: PubMed 23669270De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
Background: PubMed 37242238Fritzen R, Davies A, Veenhuizen M, Campbell M, Pitt SJ, Ajjan RA, Stewart AJ. Magnesium Deficiency and Cardiometabolic Disease. Nutrients. 2023 May 17;15(10):2355. doi: 10.3390/nu15102355.
Derived from this study: PubMed 42909966Zhou J, Liu Q, Wang L, Shen L, Zheng W, Xie C. Effects of Esketamine and Magnesium Sulfate on Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized, Double-Blind, Placebo-Controlled, 2x2 Factorial Trial. J Pain Res. 2026 Oct 17;19:636898. doi: 10.2147/JPR.S636898. eCollection 2026.
Individual participant dataSharing planned: No

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Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Christensen's Fatigue Scale (time frame: postoperative day 1 (POD1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07131033, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.