Whether Opioids Are Factor That Induced POD?

NCT ID: NCT05596071

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-25
• Study Completion Date: 2020-12-31

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

Conditions

Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Sufentanyl+Epidural analgesia

Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia

Group Type: EXPERIMENTAL

Sufentanil Citrate

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Epidural catheter

Intervention Type: PROCEDURE

Intraoperative and postoperative analgesia

Epidural analgesia

Only use of ropivacaine for intraoperative and postoperative analgesia

Group Type: SHAM_COMPARATOR

Ropivacaine 0.75% Injectable Solution

Intervention Type: DRUG

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

Epidural catheter

Intervention Type: PROCEDURE

Intraoperative and postoperative analgesia

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Epidural catheter

Intraoperative and postoperative analgesia

Intervention Type: PROCEDURE

Other Intervention Names

Sufentanil; Ropivacaine

Eligibility Criteria

Inclusion Criteria

• Patients' age ≥65 years
• Underwent elective radical gastrectomy

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Jun

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

chaoqun Fei

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2016-10-10

Identifier Type: -

Identifier Source: org_study_id