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

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ClinicalTrials.gov Identifier: NCT03763084
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

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

Condition or disease Intervention/treatment Phase
Acetaminophen Delirium in Old Age Drug: Acetaminophen Drug: Sufentanil Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: acetaminophen
For 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.
Drug: Acetaminophen
For patients in the acetaminophen group, oral acetaminophen supplemented dexmedetomidine sedation will be provided after surgery.

Active Comparator: Sufentanil
Sufentanil 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.
Drug: Sufentanil
For patients in the control group, sufentanil supplemented dexmedetomidine sedation will be provided after surgery.




Primary Outcome Measures :
  1. Frequency of delirium [ Time Frame: within the first 5 postoperative days ]
    evaluate the occurence of delirium by using Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)


Secondary Outcome Measures :
  1. Effectiveness of analgesia [ Time Frame: during postoperative days 1-5 ]
    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.

  2. Length of days in ICU and hospital stay after surgery [ Time Frame: from day 1 after surgery to discharge (up to 24 weeks) ]
    evaluate the length of days in ICU and hospital stay from postoperative to discharge

  3. Incidence of non-delirium complications [ Time Frame: with 28 days after surgery ]
    Incidence of non-delirium complications with 28 days after surgery

  4. All-cause28-day mortality [ Time Frame: day 28 after surgery ]
    All-cause28-day mortality

  5. life-Quality evaluation of 28-day survivors [ Time Frame: day 28 after surgery ]
    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

  6. Cognitive function of 28-day survivors [ Time Frame: day 28 after surgery ]
    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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Scheduled to ICU after non-cardiac surgery for any reasons;
  2. 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;
  3. Able to take oral medication or by stomach tube;
  4. Provide written informed consent.

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded.

    1. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
    2. Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
    3. Brain injury or neurosurgery;
    4. 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.
    5. Subject has a positive test result for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methamphetamine, methadone, or methylenedioxy-methamphetamine) at Screening.
    6. 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.
    7. 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.
    8. Subject has intra- or postoperative complications, which in the view of the investigator, makes the subject unsuitable for the participation of the study.
    9. 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.
    10. Unable to take medications orally or by stomach tube

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763084


Contacts
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Contact: Yuhang Ai, Prof. 8613908480631 ayhicu1978@sina.com

Locations
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China, Hunan
Xiangya Hospital, Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Xiao       xyyyllwyh@126.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Yale University

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03763084     History of Changes
Other Study ID Numbers: 2018071027
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Xiangya Hospital of Central South University:
acetaminophen
analgesia
delirium
Additional relevant MeSH terms:
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Acetaminophen
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Sufentanil
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics