Postoperative DeliriumNCT04969523
Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy
A study testing lobectomy in people with Postoperative Delirium, run by Zhongnan Hospital.
Trial summary
The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- lobectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2021to 31 Dec 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ
Who cannot join
- Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week
About this study
Official title: Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy: a Multicentre, Double-blind, Randomised Clinical Trial
The purpose of this study is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy
Read the detailed description
This study aimed to investigate the effect of IV es-ketamine vs saline on the incidence of postoperative delirium. It was hypothesized that IV es-ketamine would reduce the incidence of in-hospital delirium during cardiac surgery lobectomy
- Conditions
- Postoperative Delirium
- Being tested
- lobectomy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lobectomyProcedure or surgery
Intravenous es-ketamine 0.5mg/kg or saline during lobectomy
| Study group | Role | What they receive |
|---|---|---|
| es-ketamine | Experimental | es-ketamine 0.5mg/kg iv Receives: Procedure: lobectomy |
| saline | Placebo comparator | iv saline with the same volume of es-ketamine Receives: Procedure: lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
Confusion Assessment Method (CAM) or CAM-ICU for patients
Measured: 7 days after operation
Postoperative Cognitive Assessment
Montreal Cognitive Assessment
Measured: 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start31 Jul 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969523
- Sponsor's protocol ID
- S001
- Status last verified
- Jul 2021
- First submitted
- 19 May 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Es-ketamine on Postoperative Delirium Among Old Patients With Lobectomy: a Multicentre, Double-blind, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04969523
- Acronym / sponsor ID
- S001
- Conditions
- Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 31 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jul 2021 (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 is the efficiency of es-ketamine on postoperative delirium among old patients with elective lobectomy
Detailed description
This study aimed to investigate the effect of IV es-ketamine vs saline on the incidence of postoperative delirium. It was hypothesized that IV es-ketamine would reduce the incidence of in-hospital delirium during cardiac surgery lobectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| es-ketamine | Experimental | Procedure: lobectomyes-ketamine 0.5mg/kg iv |
| saline | Placebo comparator | Procedure: lobectomyiv saline with the same volume of es-ketamine |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 years old; There is no limit on the gender, ASA (American Society of Anesthesiologists )Ⅰ-Ⅲ
Key exclusion criteria (1 listed)
- Emergency surgery, severe hepatic and renal dysfunction, shock or coma, psychiatric disease or central nervous system disorder or a history of long-term use of psychiatric medications, cognitive dysfunction, severe arrhythmia or bradycardia, ketamine allergy,drug abuse history and used other sedatives for nearly a week
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 |
|---|---|---|
| lobectomyIntravenous es-ketamine 0.5mg/kg or saline during lobectomy | Procedure or surgery | es-ketamine, saline |
Primary outcome
Postoperative Delirium
Time frame: 7 days after operation
Confusion Assessment Method (CAM) or CAM-ICU for patients
Postoperative Cognitive Assessment
Time frame: 7 days after operation
Montreal Cognitive Assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing lobectomy in people with Postoperative Delirium, run by Zhongnan Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Postoperative Delirium (time frame: 7 days after operation). 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 20 Jul 2021.