Whether Opioids Are Factor That Induced POD?

Not Applicable

Completed

• Conditions: Postoperative Delirium
• Interventions: Drug: Sufentanil Citrate; Drug: Ropivacaine 0.75% Injectable Solution; Procedure: Epidural catheter

• Registration Number: NCT05596071
• Lead Sponsor: Zhejiang Cancer Hospital

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

Study Timeline

• Study Start: 2016-06-25
• Primary Completion: 2020-07-15
• Study Completion: 2020-12-31
• Study First Submitted: 2021-06-22
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-22
• Last Update Submitted: 2022-10-22
• Study First Posted: 2022-10-27
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanyl+Epidural analgesia	Epidural catheter	Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia
Epidural analgesia	Epidural catheter	Only use of ropivacaine for intraoperative and postoperative analgesia
Sufentanyl+Epidural analgesia	Sufentanil Citrate	Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia
Sufentanyl+Epidural analgesia	Ropivacaine 0.75% Injectable Solution	Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia
Epidural analgesia	Ropivacaine 0.75% Injectable Solution	Only use of ropivacaine for intraoperative and postoperative analgesia

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	3 days after surgery	Richmond agitation and sedation scale(RASS), the RASS score was divided into 10 sedation scales, ranging from +4 to -5, representing the patient's degree from "aggressive" to "unconscious," with each score corresponding to a state of consciousness. When the RASS score was ≥-3, the CAM-ICU assessment was performed.

Secondary Outcome Measures

Name	Time	Method
Anaesthesia related adverse event	3 days after surgery	Nausea and vomiting
Visual analogue scale(VAS)	3 days after surgery	VAS 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 pressure	3 days after surgery	Hypertension or hypotension was defined as an increase or decrease in mean arterial pressure of more than 30% at baseline

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China