Whether Opioids Are Factor That Induced POD?

University of Chinese Academy Sciences

Status: Completed

Conditions: Postoperative Delirium

Treatments: Procedure: Epidural catheter; Drug: Ropivacaine 0.75% Injectable Solution; Drug: Sufentanil Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05596071

2016-10-10

Details and patient eligibility

About

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

Full 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

Enrollment: 130 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy <18, primary school <21, junior school and above <25
• Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants
• History of alcohol abuse or a history of drug dependence
• Have brain surgery or trauma
• Cannot with the completion of tests of Postoperative Cognitive Dysfunction
• Refused to participate in the study

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

130 participants in 2 patient groups

Sufentanyl+Epidural analgesia

Experimental group

Description:

Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia

Treatment:

Drug: Sufentanil Citrate

Drug: Ropivacaine 0.75% Injectable Solution

Procedure: Epidural catheter

Epidural analgesia

Sham Comparator group

Description:

Only use of ropivacaine for intraoperative and postoperative analgesia

Treatment:

Drug: Ropivacaine 0.75% Injectable Solution

Procedure: Epidural catheter