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Clinical Trials/NCT05596071
NCT05596071
Completed
Not Applicable

Whether Opioids Are Factor That Induced Postoperative Delirium?

Zhejiang Cancer Hospital1 site in 1 country130 target enrollmentJune 25, 2016

Overview

Phase
Not Applicable
Intervention
Sufentanil Citrate
Conditions
Postoperative Delirium
Sponsor
Zhejiang Cancer Hospital
Enrollment
130
Locations
1
Primary Endpoint
Incidence of postoperative delirium
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 25, 2016
End Date
December 31, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fang Jun

Director

Zhejiang Cancer Hospital

Eligibility Criteria

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

Arms & Interventions

Sufentanyl+Epidural analgesia

Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia

Intervention: Sufentanil Citrate

Sufentanyl+Epidural analgesia

Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia

Intervention: Ropivacaine 0.75% Injectable Solution

Sufentanyl+Epidural analgesia

Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia

Intervention: Epidural catheter

Epidural analgesia

Only use of ropivacaine for intraoperative and postoperative analgesia

Intervention: Ropivacaine 0.75% Injectable Solution

Epidural analgesia

Only use of ropivacaine for intraoperative and postoperative analgesia

Intervention: Epidural catheter

Outcomes

Primary Outcomes

Incidence of postoperative delirium

Time Frame: 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 Outcomes

  • Anaesthesia related adverse event(3 days after surgery)
  • Visual analogue scale(VAS)(3 days after surgery)
  • blood pressure(3 days after surgery)

Study Sites (1)

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