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Completed

NCT Number: NCT05596071

Whether Opioids Are Factor That Induced POD?

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

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Sufentanil

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

Other names: Ropivacaine

epidural catheter

Procedure

Intraoperative and postoperative analgesia

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: 3 days after surgery

    confusion assessment method for the ICU(CAM-ICU)

  2. Incidence of postoperative delirium

    Time frame: 3 days after surgery

    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 outcomes

  1. Visual analogue scale(VAS)

    Time frame: 3 days after surgery

    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.

  2. Anaesthesia related adverse event

    Time frame: 3 days after surgery

    Nausea and vomiting

  3. blood pressure

    Time frame: 3 days after surgery

    Hypertension or hypotension was defined as an increase or decrease in mean arterial pressure of more than 30% at baseline

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Whether Opioids Are Factor That Induced Postoperative Delirium?

Acronym: POD

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2022
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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