Whether Opioids Are Factor That Induced POD?

NCT05596071 | Completed

• 1 other identifier: 2016-10-10
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Delirium

Keywords

opioid; POD; gastric cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Visual analogue scale(VAS)

  3 days after surgery

• Anaesthesia related adverse event

  3 days after surgery

• blood pressure

  3 days after surgery

Study Arms (2)

Sufentanyl+Epidural analgesia

EXPERIMENTAL

Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia

Drug: Sufentanil Citrate; Drug: Ropivacaine 0.75% Injectable Solution; Procedure: Epidural catheter

Epidural analgesia

SHAM COMPARATOR

Only use of ropivacaine for intraoperative and postoperative analgesia

Drug: Ropivacaine 0.75% Injectable Solution; Procedure: Epidural catheter

Interventions

Sufentanil Citrate 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

Also known as: Sufentanil

Sufentanyl+Epidural analgesia

Ropivacaine 0.75% Injectable Solution 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

Also known as: Ropivacaine

Epidural analgesia; Sufentanyl+Epidural analgesia

Epidural catheter PROCEDURE

Intraoperative and postoperative analgesia

Epidural analgesia; Sufentanyl+Epidural analgesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Emergence Delirium; Stomach Neoplasms

Interventions

Sufentanil; Ropivacaine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• chaoqun Fei

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: October 27, 2022
• Study Start: June 25, 2016
• Primary Completion: July 15, 2020
• Study Completion: December 31, 2020
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)