Whether Opioids Are Factor That Induced POD?

Postoperative Delirium Clinical Trial

— POD  

Official title:

Whether Opioids Are Factor That Induced Postoperative Delirium?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05596071
• Other study ID #: 2016-10-10
• Status: Completed
• Phase: N/A
• Start date: June 25, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2022
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 31, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Drug:
• Sufentanil Citrate
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
• Ropivacaine 0.75% Injectable Solution
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

Procedure:
• Epidural catheter
Intraoperative and postoperative analgesia

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium	confusion assessment method for the ICU(CAM-ICU)	3 days after surgery
Primary	Incidence of postoperative delirium	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.	3 days after surgery
Secondary	Visual analogue scale(VAS)	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.	3 days after surgery
Secondary	Anaesthesia related adverse event	Nausea and vomiting	3 days after surgery
Secondary	blood pressure	Hypertension or hypotension was defined as an increase or decrease in mean arterial pressure of more than 30% at baseline	3 days after surgery