Whether Opioids Are Factor That Induced POD? (POD)

Whether Opioids Are Factor That Induced Postoperative Delirium?

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

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: Sufentanil Citrate; Drug: Ropivacaine 0.75% Injectable Solution; Procedure: Epidural catheter

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sufentanyl+Epidural analgesia; Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia	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; Other Names: Sufentanil; Drug: 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; Other Names: Ropivacaine; Procedure: Epidural catheter; Intraoperative and postoperative analgesia
Sham Comparator: Epidural analgesia; Only use of ropivacaine for intraoperative and postoperative analgesia	Drug: 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; Other Names: Ropivacaine; Procedure: Epidural catheter; Intraoperative and postoperative analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative delirium	confusion assessment method for the ICU(CAM-ICU)	3 days after surgery
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Anaesthesia related adverse event	Nausea and vomiting	3 days after surgery
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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: chaoqun Fei, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2016
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: October 22, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 22, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: opioid; gastric cancer; POD
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Ropivacaine; Sufentanil; Dsuvia
• Other Study ID Numbers: 2016-10-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: this study individual statistics is not available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No