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

NCT03763084 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: 2018071027
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Acetaminophen; Delirium in Old Age

Keywords

acetaminophen; analgesia; delirium

Outcome Measures

Primary Outcomes (1)

• Frequency of delirium

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

  within the first 5 postoperative days

Secondary Outcomes (6)

• Effectiveness of analgesia

  during postoperative days 1-5

• Length of days in ICU and hospital stay after surgery

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

• Incidence of non-delirium complications

  with 28 days after surgery

• All-cause28-day mortality

  day 28 after surgery

• life-Quality evaluation of 28-day survivors

  day 28 after surgery

Study Arms (2)

acetaminophen

EXPERIMENTAL

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

Sufentanil

ACTIVE COMPARATOR

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

Interventions

Acetaminophen DRUG

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

acetaminophen

Sufentanil DRUG

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

Sufentanil

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Yale University: collaborator

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Agnosia; Delirium

Interventions

Acetaminophen; Sufentanil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Confusion; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Yuhang Ai, Prof.

CONTACT

8613908480631; ayhicu1978@sina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: December 4, 2018
• Study Start: February 15, 2019
• Primary Completion: February 1, 2020
• Study Completion: November 1, 2020
• Last Updated: March 8, 2019

Record last verified: 2018-11

Locations

CN (1)