Paracetamol and Mannitol Injection and Postoperative Delirium
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorXiangya Hospital of Central South University
About this trial
The aim of this multi-center RCT is to investigate the effect of intravenous acetaminophen (paracetamol and mannitol injection) on postoperative delirium, comparing with intravenous sufentanil, in elderly noncardiac surgical patients admitted to ICU.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 60 years;
Admitted to ICU after a noncardiac surgical procedure
Moderate to severe acute pain, with a postoperative pain score ≥ 5 based on the 11-point Numerical Pain Rating Scale (NPRS)
Signed informed consent form
Disqualifiers
Preoperative medical history: schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis
History of psychiatric disease or significant neurocognitive disorder such as dementia or retardation, making POD assessment impossible
Language or communication barrier making POD assessment impossible
Intracranial surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Acetaminophen group
DrugThe pain in this group is controlled using acetaminophen (Paracetamol and Maninitol Injection, Yichang Renfu Medicine Co., Ltd., China), 500 mg, intravenous bolus, every 6 hours for the first 48 hours postoperatively. The severity of pain is assessed using NRS every 15 minutes during the first hour following ICU admission and then once every 12 hours needed.
Sufentanil group
Drughe pain in this group is controlled using sufentanil (Yichang Renfu Medicine Co., Ltd., China) intravenous infusion with a rate of 0.05 μg/kg/h. The severity of pain is assessed using NRS every 15 minutes during the first hour following ICU admission and then once every 12 hours needed.
Treatment groups
1,092 Participants
are divided into 2 treatment groupsGroup A: Acetaminophen groupExperimental treatment 1 intervention
Group B: Sufentanil groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of delirium
Delirium assessed using CAM-ICU every 12 hours (8am, 8 pm) during postoperative days 1-5 and RASS transform at any time
Time frame
postoperative 1- 5 daysSecondary outcomes
1
All-cause mortality
30-days outcome (survival or death) after surgery; Patients will be assessed via phone call if they are discharged before day 30 after surgery
Time frame
30-day after surgery2
Severity of pain
Severity of pain assessed using numeric rating scale (NRS), 8am and 8pm, twice a day, for 5 day The scale consists of 11 points from 0 to 10, where 0 indicates "no pain" and 10 indicates "severe pain". Patients select the corresponding number based on their pain level. \<4 points indicate mild pain (no impact on sleep), 4-6 points indicate moderate pain, and ≥7 points indicate severe pain (pain prevents sleep or causes waking).
Time frame
postoperative days 1-53
Length of ICU stay
Length of ICU stay after surgery admitted to ICU
Time frame
immediately after surgery4
Length of hospital stay
Length of hospital stay within hospital admission
Time frame
immediately after surgeryOther outcomes
1
Sleep quality
Subjective quality of sleep assessed using NRS (an 11-point scale where 0 = the best sleep and 10 = the worst sleep) once daily (8:00-10:00 am) during postoperative days 1-5
Time frame
postoperative days 1-52
Biomarker of delirium
Biomarker of delirium including S100b and NSE on postoperative day 1
Time frame
Postoperative day 13
Neuro monitoring of delirium
Monitoring of neurophysiological function, with detecting SctO2 during postoperative days 1-5
Time frame
Postoperative days 1-5Sponsors and contacts
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Source ClinicalTrials.gov
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