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Whether Opioids Are Factor That Induced POD? (POD)

Primary Purpose

Postoperative Delirium

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sufentanil Citrate
Ropivacaine 0.75% Injectable Solution
Epidural catheter
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postoperative Delirium focused on measuring opioid, POD, gastric cancer

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Sufentanyl+Epidural analgesia

Epidural analgesia

Arm Description

Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia

Only use of ropivacaine for intraoperative and postoperative analgesia

Outcomes

Primary Outcome Measures

Incidence of postoperative delirium
confusion assessment method for the ICU(CAM-ICU)
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.

Secondary Outcome Measures

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.
Anaesthesia related adverse event
Nausea and vomiting
blood pressure
Hypertension or hypotension was defined as an increase or decrease in mean arterial pressure of more than 30% at baseline

Full Information

First Posted
June 22, 2021
Last Updated
October 22, 2022
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05596071
Brief Title
Whether Opioids Are Factor That Induced POD?
Acronym
POD
Official Title
Whether Opioids Are Factor That Induced Postoperative Delirium?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 25, 2016 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
opioid, POD, gastric cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sufentanyl+Epidural analgesia
Arm Type
Experimental
Arm Description
Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia
Arm Title
Epidural analgesia
Arm Type
Sham Comparator
Arm Description
Only use of ropivacaine for intraoperative and postoperative analgesia
Intervention Type
Drug
Intervention Name(s)
Sufentanil Citrate
Other Intervention Name(s)
Sufentanil
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.75% Injectable Solution
Other Intervention Name(s)
Ropivacaine
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Epidural catheter
Intervention Description
Intraoperative and postoperative analgesia
Primary Outcome Measure Information:
Title
Incidence of postoperative delirium
Description
confusion assessment method for the ICU(CAM-ICU)
Time Frame
3 days after surgery
Title
Incidence of postoperative delirium
Description
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.
Time Frame
3 days after surgery
Secondary Outcome Measure Information:
Title
Visual analogue scale(VAS)
Description
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.
Time Frame
3 days after surgery
Title
Anaesthesia related adverse event
Description
Nausea and vomiting
Time Frame
3 days after surgery
Title
blood pressure
Description
Hypertension or hypotension was defined as an increase or decrease in mean arterial pressure of more than 30% at baseline
Time Frame
3 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chaoqun Fei
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
this study individual statistics is not available

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Whether Opioids Are Factor That Induced POD?

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