Postoperative DeliriumPODNCT05596071
Whether Opioids Are Factor That Induced POD?
A study testing Sufentanil Citrate, Ropivacaine 0.75% Injectable Solution and Epidural catheter in people with Postoperative Delirium, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study was to investigate whether perioperative use of low doses of opioids could reduce postoperative delirium . Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Sufentanil Citrate, Ropivacaine 0.75% Injectable Solution and Epidural catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients' age ≥65 years
- Underwent elective radical gastrectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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
- Being tested
- Sufentanil Citrate, Ropivacaine 0.75% Injectable Solution, Epidural catheter
- Keywords
- opioid, POD, gastric cancer
- Medical subject headings
- Emergence Delirium, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil CitrateDrug
Also called Sufentanil
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 SolutionDrug
Also called Ropivacaine
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 catheterProcedure or surgery
Intraoperative and postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Sufentanyl+Epidural analgesia | Experimental | Combined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia Receives: 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 Receives: Drug: Ropivacaine 0.75% Injectable Solution; Procedure: Epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
confusion assessment method for the ICU(CAM-ICU)
Measured: 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.
Measured: 3 days after surgery
Secondary outcomes (3)
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.
Measured: 3 days after surgery
Anaesthesia related adverse event
Nausea and vomiting
Measured: 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
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start25 Jun 2016
- Primary completion15 Jul 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Jun, Zhejiang Cancer Hospital
- Investigators
- chaoqun Fei, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596071
- Sponsor's protocol ID
- 2016-10-10
- Acronym
- POD
- Status last verified
- Oct 2022
- First submitted
- 22 Jun 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: this study individual statistics is not available
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether Opioids Are Factor That Induced Postoperative Delirium?
- ClinicalTrials.gov ID
- NCT05596071
- Acronym / sponsor ID
- POD / 2016-10-10
- Conditions
- Postoperative Delirium
- Keywords
- opioid, POD, gastric cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 25 Jun 2016 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanyl+Epidural analgesia | Experimental | Drug: Sufentanil Citrate, Drug: Ropivacaine 0.75% Injectable Solution, Procedure: Epidural catheterCombined use of sufentanil and ropivacaine for intraoperative and postoperative analgesia |
| Epidural analgesia | Sham comparator | Drug: Ropivacaine 0.75% Injectable Solution, Procedure: Epidural catheterOnly use of ropivacaine for intraoperative and postoperative analgesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients' age ≥65 years
- Underwent elective radical gastrectomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sufentanil CitrateAlso: SufentanilIntraoperative 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 | Drug | Sufentanyl+Epidural analgesia |
| Ropivacaine 0.75% Injectable SolutionAlso: RopivacaineIntraoperative 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 | Drug | Epidural analgesia, Sufentanyl+Epidural analgesia |
| Epidural catheterIntraoperative and postoperative analgesia | Procedure or surgery | Epidural analgesia, Sufentanyl+Epidural analgesia |
Primary outcome
Incidence of postoperative delirium
Time frame: 3 days after surgery
confusion assessment method for the ICU(CAM-ICU)
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.
3 secondary outcomes
Visual analogue scale(VAS)
Time frame: 3 days after surgery
Anaesthesia related adverse event
Time frame: 3 days after surgery
blood pressure
Time frame: 3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No. this study individual statistics is not available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
chaoqun Fei principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil Citrate, Ropivacaine 0.75% Injectable Solution and Epidural catheter in people with Postoperative Delirium, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: 3 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022; AzTrials last refreshed its copy on 31 Oct 2026.