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
|Condition or disease||Intervention/treatment||Phase|
|Acetaminophen Delirium in Old Age||Drug: Acetaminophen Drug: Sufentanil||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
For patients in the control group, sufentanil supplemented dexmedetomidine sedation will be provided after surgery.
- 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)
- 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.
- 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
- Incidence of non-delirium complications [ Time Frame: with 28 days after surgery ]Incidence of non-delirium complications with 28 days after surgery
- All-cause28-day mortality [ Time Frame: day 28 after surgery ]All-cause28-day mortality
- 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
- 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
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
|Contact: Yuhang Ai, Prof.||firstname.lastname@example.org|
|Xiangya Hospital, Central South University||Recruiting|
|Changsha, Hunan, China, 410000|
|Contact: Xiao email@example.com|