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Whether Opioids Are Factor That Induced POD?

Whether Opioids Are Factor That Induced Postoperative Delirium?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05596071
Acronym
POD
Enrollment
130
Registered
2022-10-27
Start date
2016-06-25
Completion date
2020-12-31
Last updated
2022-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Keywords

opioid, POD, gastric cancer

Brief summary

The purpose of this study was to investigate whether perioperative use of low doses of opioids could reduce postoperative delirium .

Detailed description

Postoperative delirium (POD) is a common postoperative complication of the elderly caused by a variety of factors. POD is an acute neuropsychiatric disorder characterized by disturbance of attention consciousness and cognitive function fluctuation, and more than 40% of elderly patients have symptoms of hypoactivity POD.The incidence of POD is as high as 17% to 61% in patients with neurocognitive impairment and patients undergoing complex or emergency surgery, which usually occurs between 1 and 3 days after surgery. POD will lead to prolonged hospital stay, functional impairment and even death. How to prevent and treat POD is an urgent clinical problem to be solved at present. Opiates are commonly used perioperative sedatives and analgesics, which may be associated with the occurrence of postoperative POD in elderly patients and increase the risk of POD. It is not clear whether perioperative use of low doses of opioids could reduces the incidence of POD in elderly patients. In this study, reducing-opioids anesthesia was defined as the use of 1/3 of the conventional opioid dose to observe whether reducing-opioids anesthesia affected the incidence of POD in elderly patients undergoing gastric cancer surgery

Interventions

Intraoperative loading dose of sufentanil 0.6μg/kg, each additional hour 10μg, within one hour of the end of surgery to stop additional.Postoperative analgesia pump formula: sufentanil 150ug + 0.75% ropivacaine 60ml with 0.9% saline diluted to 220ml, 3ml

Intraoperative epidural analgesia was performed with 0.5% ropivacaine 5-20 ml,Postoperative analgesia pump formula:0.75% ropivacaine 60ml with 0.9% saline diluted to 220ml, 3ml/h, Blos 3ml, locking time 15min, the maximum dose of 36ml in 4 hours Saline is used to dilute other drugs

Intraoperative and postoperative analgesia

Sponsors

Zhejiang Cancer Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients' age ≥65 years * Underwent elective radical gastrectomy

Exclusion criteria

* Mini-Mental Scale Test (MMSE)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative delirium3 days after surgeryconfusion assessment method for the ICU(CAM-ICU)

Secondary

MeasureTime frameDescription
Anaesthesia related adverse event3 days after surgeryNausea and vomiting
Visual analogue scale(VAS)3 days after surgeryVAS is a scale of 11 numbers ranging from 0 to 10, with 0 representing no pain and 10 representing the most pain. Patients choose one of the 11 numbers to represent the pain level according to their own pain. 0: no pain; Less than 3 points: mild pain, tolerable; 4-6 points: the patient's pain and affect sleep, still tolerable; 7-10: Patients have increasing pain, pain is unbearable, affect appetite, affect sleep.
blood pressure3 days after surgeryHypertension or hypotension was defined as an increase or decrease in mean arterial pressure of more than 30% at baseline

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026