Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorRenJi Hospital

About this trial

Investigators propose this multi-center randomised controlled study to test the preventive effect of intravenouse acetaminophen in delirium over 5 postoperative days among older patients recovering from major non-cardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65 years.

Scheduled for non-cardiac major surgery with general anesthesia that is expected to last more than 2h.

ASA Physical Status I-III.

Weight >50 kg.

Disqualifiers

Pre-existing neuropsychiatric diseases (Alzheimer's disease, Schizophrenia, Parkinson's Disease, Seizures, etc.).

Pre-existing cognitive impairment (MMSE<18).

Preoperative delirium.

Severe circulatory instability (preoperative left ventricular ejection fraction less than 30%, unstable angina, severe coronary artery disease, sick sinus syndrome, etc.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetaminophen

    Drug

    Acetaminophen, which has similarly effects with NSAIDs in terms of inhibition of cyclooxygenase COX1, COX2 and COX3, is widely used as adjuvant for perioperative multimodal analgesia.

  • Saline

    Drug

    Saline, a kind of crystalloid widely used in clinical treatment.

Treatment groups

1,930 Participants
are divided into 2 treatment groups
Group A: intravenous aceteminophen groupExperimental treatment 1 intervention
Group B: saline placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative delirium

Delirium will be assessed by the trained investigators twice daily, from 8-10 AM and from 5-7 PM, starting from postoperative day 1 using 3-minute Confusion Assessment Method (3D-CAM) or CAM-ICU for intubated patients. Immediately before assessing delirium, sedation or agitation was assessed using Richmond Agitation-Sedation Scale (RASS). If the patient was too deeply sedated or unarousable (RASS -4 or -5), delirium assessment was aborted and the patient was recorded as comatose.

Time frame
Participants will be followed up during the first 5 postoperative days.

Secondary outcomes

1

Delirium type

Patients with delirium were classified into three motoric subtypes. Hyperactive delirium was defined when RASS was consistently positive (+1 to +4); hypoactive delirium was defined when RASS was consistently neutral or negative (-3 to 0); and mixed delirium was defined when some RASS scores were positive (+1 to +4) and some RASS scores were neutral or negative (-3 to 0).

Time frame
Participants will be followed up during the first 5 postoperative days.
2

Delirium severity

Delirium rating scale 98 revised (DRS-R-98) will be used to evaluate severity of delirium. DRS-R-98 consists of 16 items, including 13 items to assess severity of delirium and 3 diagnostic items. The total severity score range from zero (best) to 39 (worst).

Time frame
Participants will be followed up during the first 5 postoperative days.
3

Pain scores

Pain scores will be assessed using numerical rating scale (NRS) once daily, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable".

Time frame
Participants will be followed up during the first 5 postoperative days.
4

Total opioid consumption

Amount of intravenous and/or oral opioid consumption for analgesia will be recorded.

Time frame
Participants will be followed up during the first 5 postoperative days.

Other outcomes

1

Cognitive function

Cognitive function will be evaluated with Mini-Mental State Examination (MMSE) score that ranges from zero (worst) to 30 (best).

Time frame
Cognitive function will be evaluated on the fifth day after operation.
2

Length of days in ICU and hospital after surgery

Length of stay in ICU and hospital after surgery will be collected from electronic medical records.

Time frame
one month
3

All cause mortality

Time frame
one month

Locations

This trial has no locations.

Sponsors and contacts

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