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

NCT ID: NCT03763084

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2020-11-01

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.

Conditions

Acetaminophen; Delirium in Old Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Sufentanil

Intervention Type: DRUG

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

Interventions

Acetaminophen

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

Intervention Type: DRUG

Sufentanil

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuhang Ai, Prof.

Role: CONTACT

ayhicu1978@sina.com

8613908480631

Facility Contacts

Xiao

Role: primary

xyyyllwyh@126.com

Other Identifiers

2018071027

Identifier Type: -

Identifier Source: org_study_id