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AcetaminophenEarly Phase 1NCT03763084

Impact of Acetaminophen on Postoperative Delirium Elderly Patients After Non-cardiac Surgery

A Early Phase 1 study testing Acetaminophen and Sufentanil in people with Acetaminophen and Delirium in Old Age, run by Xiangya Hospital of Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate the impact of acetaminophen analgesia on the frequency of postoperative delirium and 28 days mortality in elderly patients after noncardiac surgery. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Acetaminophen, Delirium in Old Age
What is being tested?
Acetaminophen and Sufentanil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
1 siteChina
Study dates
15 Feb 2019to 1 Nov 2020
Phase
Early Phase 1
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Scheduled to ICU after non-cardiac surgery for any reasons；
  • Report having moderate to severe acute pain as determined by a pain score ≥ 5 from the 11-point Numeric Pain Rating Scale (NPRS) scale after postsurgery；
  • Able to take oral medication or by stomach tube；
  • Provide written informed consent.

Who cannot join

  • Patients who meet any of the following criteria will be excluded.
  • Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
  • Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
  • Brain injury or neurosurgery;
  • Severe hepatic dysfunction (eg, aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than or equal to 3.0 times the upper limit of normal), active hepatic disease, evidence of clinically significant liver disease, or other condition (eg, alcoholism, cirrhosis, or hepatitis) that suggests the potential for an increased susceptibility to hepatic toxicity with study drug exposure.
  • Subject has a positive test result for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methamphetamine, methadone, or methylenedioxy-methamphetamine) at Screening.
Show all 11Show fewer
  • Subject has participated in another clinical study within 30 days prior to day-of-surgery or plans to participate in another clinical study while concurrently enrolled in this study.
  • Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or morphine or to any of the excipients in the IV or oral formulations used.
  • Subject has intra- or postoperative complications, which in the view of the investigator, makes the subject unsuitable for the participation of the study.
  • Subject has a history of any drug allergy, hypersensitivity, or intolerance to acetaminophen or opioid or to any of the excipients in the IV or oral formulations used.
  • Unable to take medications orally or by stomach tube

Trial locations and contacts

1 site in 1 country.

Yuhang Ai, Prof. contact

8613908480631

ayhicu1978@sina.com

China1 site, 1 recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410000

    Xiao, xyyyllwyh@126.com

    Recruiting

Other trials in China

About this study

Official title: Impact of Oral Acetaminophen Analgesia on Postoperative Delirium and Long-term Survival in Elderly Patients After Non-cardiac Surgery: A Randomized Controlled Trial

To investigate the impact of acetaminophen analgesia on the frequency of postoperative delirium and 28 days mortality in elderly patients after noncardiac surgery.

Read the detailed description

Background: Delirium is a common complication following surgery contributes to adverse outcomes, including increased mortality and morbidity, longer length of ICU stays, prolonged mechanical ventilation, and costlier hospitalizations. Previous studies showed that, the incidence of delirium for seniors patients admitted to ICU can reach up to 58%-75.6% depending on the patient population and screening instrument. The current protocols for perioperative opioid use and postoperative pain management may influence the occurrence of delirium. We hypothesize that the use of oral acetaminophen (OVA) may lead to reduced opioid consumption and decreased incidence of postoperative delirium.

Objectives: To investigate the impact of acetaminophen analgesia on the frequency of postoperative delirium and 28 days mortality in elderly patients after noncardiac surgery.

Study design: A randomized and controlled trial. Setting: Departments of critical care medicine of tertiary hospital (Xiangya) in China.

Patients: 164 elderly patients (≥ 65 years) who are scheduled to admitted to ICU after major surgery (predicted duration ≥ 2 hours) Intervention: For patients in the acetaminophen group, oral acetaminophen supplemented dexmedetomidine sedation will be provided after surgery. For patients in the control group, sufentanil supplemented dexmedetomidine sedation will be provided after surgery. the other analgesia drugs will be provided as back up in study group.

Primary outcome: Early primary endpoint is the frequency of delirium in the first 5-days post-surgery. Secondary endpoints include biomark and NeuroMonitoring of delirium, 28days and in-hospital mortality, length of stay days in ICU and hospital, complication in hospital.

Predicted duration of the study: 2 years.

Being tested
Acetaminophen, Sufentanil
Keywords
acetaminophen, analgesia, delirium
Medical subject headings
Agnosia, Delirium

What participants receive

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

  • AcetaminophenDrug

    For patients in the acetaminophen group, oral acetaminophen supplemented dexmedetomidine sedation will be provided after surgery.

  • SufentanilDrug

    For patients in the control group, sufentanil supplemented dexmedetomidine sedation will be provided after surgery.

Study groups in NCT03763084
Study groupRoleWhat they receive
acetaminophenExperimentalFor patients randomized to OVA group, OVA 500mg was given every 8 hours for the first 48 hours postoperatively. Numeric Pain Rating Scale pain score is assessed every 15 minutes during the 1 hour of ICU stay and when needed.
Receives: Drug: Acetaminophen
SufentanilActive comparatorSufentanil injection 500μg /10ml in normal saline, total volume 50 ml.Constant infusion dosage is 0.05μg/kg/h. Numeric Pain Rating Scale pain score is assessed every 15 minutes during the 1 hour of ICU stay and when needed.
Receives: Drug: Sufentanil

What is being measured

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

  1. Frequency of delirium

    evaluate the occurence of delirium by using Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)

    Measured: within the first 5 postoperative days

Secondary outcomes (6)

  1. Effectiveness of analgesia

    to assess the effect of analgesia by using Numerical Rating Scale (NRS)；This method is composed of 0 to 10, a total of 11 Numbers. Patients with 0 to 10 this digital describe pain intensity, the greater the number the pain degree is more serious.0 painless, 1 ~ 3 mild pain (pain does not affect sleep), 4 ~ 6 moderate pain, 7 ~ 9 severe pain (couldn't sleep), 10 severe pain. We should ask the patient pain degree, tag, or let the patient draw one of the most can represent their own pain degree of digital.

    Measured: during postoperative days 1-5

  2. Length of days in ICU and hospital stay after surgery

    evaluate the length of days in ICU and hospital stay from postoperative to discharge

    Measured: from day 1 after surgery to discharge (up to 24 weeks)

  3. Incidence of non-delirium complications

    Incidence of non-delirium complications with 28 days after surgery

    Measured: with 28 days after surgery

  4. All-cause28-day mortality

    All-cause28-day mortality

    Measured: day 28 after surgery

  5. life-Quality evaluation of 28-day survivors

    evaluate the quality of life by using the world health organization quality of life measurement scale(WHOQOL-BREF). WHOQOL-BREF contains 26 items, summarizes the physiological, psychological, social relations, the environment in the field of four content.Consists of two independent analysis problem items: question 1 (G1) ask individual about their quality of life of the general subjective feeling, question 2 (G4) individual asked the total subjective feeling bout their own health. Domain scores are the positive (i.e., the higher the score, the better the quality of life).Field scoring through the calculation of average of their entries 4 times. and patients will be assessed via phone call if they are discharged before day 28 after surgery

    Measured: day 28 after surgery

  6. Cognitive function of 28-day survivors

    evaluate the cognitive function of 28-day survivors by using modified version of the telephone questionnaire for cognitive function questionnaire (TICS-m);It contains 21 items, total score 50 points, can be divided into three parts: the memory part (score 20), directional force (score 13), the capablity of language, and pay attention (score 17). TICS -m total score 50 points, scored < 28 divided into dementia, 28 and 33 were divided into mild cognitive dysfunction, ≥33 were divided into normal. Patients will be assessed via phone call if they are discharged before day 28 after surgery

    Measured: day 28 after surgery

Timeline

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

  1. First posted4 Dec 2018
  2. Study start15 Feb 2019
  3. Primary completion1 Feb 2020 (estimated)
  4. Study completion1 Nov 2020 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03763084
Sponsor's protocol ID
2018071027
Status last verified
Nov 2018
First submitted
2 Dec 2018
Last updated
8 Mar 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Zhang L, Peng M, Zhang H, Xiang C, Ai Y, Kong Y, Xiang M, Qian Z, Meng L. Oral acetaminophen and postoperative delirium in noncardiac surgical older patients requiring intensive care unit admission: A pragmatic randomized controlled trial. J Intensive Med. 2025 Dec 26;6(2):141-149. doi: 10.1016/j.jointm.2025.10.005. eCollection 2026 Apr.

    PubMed 42028138

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Acetaminophen and Sufentanil in people with Acetaminophen and Delirium in Old Age, run by Xiangya Hospital of Central South University at 1 site in China.

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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Mar 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Yuhang Ai, Prof. (8613908480631, ayhicu1978@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of delirium (time frame: within the first 5 postoperative days). 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 NCT03763084, which also lists 1 linked publication.

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 8 Mar 2019.

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