Back to resultsImpact of Acetaminophen on Postoperative Delirium Elderly Patients After Non-cardiac Surgery
Primary Purpose
Acetaminophen, Delirium in Old Age
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Acetaminophen
Sufentanil
Sponsored by
About this trial
This is an interventional prevention trial for Acetaminophen focused on measuring acetaminophen, analgesia, delirium
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
- 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
Sites / Locations
- Xiangya Hospital, Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
acetaminophen
Sufentanil
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Frequency of delirium
evaluate the occurence of delirium by using Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
Secondary Outcome Measures
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.
Length of days in ICU and hospital stay after surgery
evaluate the length of days in ICU and hospital stay from postoperative to discharge
Incidence of non-delirium complications
Incidence of non-delirium complications with 28 days after surgery
All-cause28-day mortality
All-cause28-day mortality
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
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
Full Information
NCT ID
NCT03763084
First Posted
December 2, 2018
Last Updated
March 6, 2019
Sponsor
Xiangya Hospital of Central South University
Collaborators
Yale University
1. Study Identification
Unique Protocol Identification Number
NCT03763084
Brief Title
Impact of Acetaminophen on Postoperative Delirium Elderly Patients After Non-cardiac Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
Collaborators
Yale University
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetaminophen, Delirium in Old Age
Keywords
acetaminophen, analgesia, delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acetaminophen
Arm Type
Experimental
Arm Description
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.
Arm Title
Sufentanil
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
For patients in the acetaminophen group, oral acetaminophen supplemented dexmedetomidine sedation will be provided after surgery.
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
For patients in the control group, sufentanil supplemented dexmedetomidine sedation will be provided after surgery.
Primary Outcome Measure Information:
Title
Frequency of delirium
Description
evaluate the occurence of delirium by using Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
Time Frame
within the first 5 postoperative days
Secondary Outcome Measure Information:
Title
Effectiveness of analgesia
Description
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.
Time Frame
during postoperative days 1-5
Title
Length of days in ICU and hospital stay after surgery
Description
evaluate the length of days in ICU and hospital stay from postoperative to discharge
Time Frame
from day 1 after surgery to discharge (up to 24 weeks)
Title
Incidence of non-delirium complications
Description
Incidence of non-delirium complications with 28 days after surgery
Time Frame
with 28 days after surgery
Title
All-cause28-day mortality
Description
All-cause28-day mortality
Time Frame
day 28 after surgery
Title
life-Quality evaluation of 28-day survivors
Description
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
Time Frame
day 28 after surgery
Title
Cognitive function of 28-day survivors
Description
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
Time Frame
day 28 after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuhang Ai, Prof.
Phone
8613908480631
Email
ayhicu1978@sina.com
Facility Information:
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao
Email
xyyyllwyh@126.com
12. IPD Sharing Statement
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Impact of Acetaminophen on Postoperative Delirium Elderly Patients After Non-cardiac Surgery
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