Postoperative DeliriumPhase 4PRIDeNCT02433041
Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
A Phase 4 study testing Haloperidol, Ketamine and Haloperidol + Ketamine in people with Postoperative Delirium, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Haloperidol, Ketamine and Haloperidol + Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to 21 Dec 2018
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years and older
- Signed agreement
Who cannot join
- Delirium at admittance or MMSE score <24 points
- High risk for postoperative ICU treatment
- Haloperidol or Ketamine intolerance
- Risk of lack of cooperation
- Drug an alcohol abuse
- Dementia
Show all 14Show fewer
- QT interval (QTc) prolongation (at least 460ms in men, at least 470ms women) or drugs influencing QT interval, such as class Ia and III antiarrhythmics, Gatifloxacin, Moxifloxacin, Pentamidin, Cotrimoxazol, Tacrolimus, Dolasetron
- Parkinson's disease
- Intake of dopaminergic drugs (Levodopa, dopamine agonists)
- Parkinsonism
- Epilepsy
- Unable to be interviewed (severe Dementia, speaking disorders, intubation, respiratory isolation, aphasia, coma, terminal illness)
- Delay of operation of more than 72 hours past hospital admittance
- Body weight >100kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
The purpose of this study is to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.
Read the detailed description
The postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. Over the years numerous risk factors were detected which emphasizes the importance of its prevention. Within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. This is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving Haloperidol, one Ketamine, one both and one placebo. The patients receive the study drug only once right before induction of anesthesia. After the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with Mini Mental Status Examination (MMSE), Delirium Observation Scale (DOS), Nursing Delirium Screening Scale (Nu-DESC) or Intensive Care Delirium Screening Checklist (ICDSC). Additionally the investigators will measure and compare pre- and postoperative Cortisol, NSE and S-100beta levels.
- Conditions
- Postoperative Delirium
- Being tested
- Haloperidol, Ketamine, Haloperidol + Ketamine, Saline solution (NaCl 0.9%)
- Keywords
- Postoperative delirium, Cortisol, NSE, S-100beta, MMSE, Nu-DESC, ICDSC, DOS, Haloperidol, Ketamine, Combination of Haloperidol and Ketamine, Placebo, Prevention of
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Haloperidol 0.005mg/kg at induction of anesthesia
KetamineDrug
Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
Haloperidol + KetamineDrug
Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together
Saline solution (NaCl 0.9%)Drug
Placebo being used in one of the four groups
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol | Active comparator | Haloperidol 0.005mg/kg at induction of anesthesia Receives: Drug: Haloperidol |
| Ketamine | Active comparator | Ketamine 1mg/kg at induction of anesthesia Receives: Drug: Ketamine |
| Haloperidol + Ketamine | Active comparator | Combination of Haloperidol + Ketamine in same dosage at induction of anesthesia Receives: Drug: Haloperidol + Ketamine |
| Saline solution (NaCl 0.9%) | Placebo comparator | Placebo Receives: Drug: Saline solution (NaCl 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days
Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded)
Measured: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
Secondary outcomes (1)
Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters
Drop of one point in Nursing Delirium Screening Scale (Nu-DESC) compared pre- and postoperatively, comparison of levels of NSE, S-100beta and Cortisol (significantly elevated postoperatively?)
Measured: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJul 2013
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baden
- Responsible party
- Sponsor
- Investigators
- Alexa Hollinger, MD, Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433041
- Sponsor's protocol ID
- 2013DR4089
- Acronym
- PRIDe
- Status last verified
- Jan 2019
- First submitted
- 7 Apr 2015
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hollinger A, Rust CA, Riegger H, Gysi B, Tran F, Brugger J, Huber J, Toft K, Surbeck M, Schmid HR, Rentsch K, Steiner L, Siegemund M. Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial. J Clin Anesth. 2021 Feb;68:110099. doi: 10.1016/j.jclinane.2020.110099. Epub 2020 Oct 22.
PubMed 33120302Riegger H, Hollinger A, Seifert B, Toft K, Blum A, Zehnder T, Siegemund M. Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe): a phase IV multicenter, randomized, placebo-controlled, double-blind clinical trial of ketamine versus haloperidol for prevention of postoperative delirium. Trials. 2018 Feb 26;19(1):142. doi: 10.1186/s13063-018-2498-6.
PubMed 29482596
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baden PRIDe Trial - Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial
- ClinicalTrials.gov ID
- NCT02433041
- Acronym / sponsor ID
- PRIDe / 2013DR4089
- Conditions
- Postoperative Delirium
- Keywords
- Postoperative delirium, Cortisol, NSE, S-100beta, MMSE, Nu-DESC, ICDSC, DOS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Kantonsspital Baden
- Study start
- Jul 2013
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 4 May 2015 (estimated)
- 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 to find out whether postoperative delirium can be more properly prevented by the combination of determined preventive agents in past studies. Further on the investigators measure pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100beta levels.
Detailed description
The postoperative delirium remains a challenge for medical stuff concerning detection, therapy and avoidance of consequences. Over the years numerous risk factors were detected which emphasizes the importance of its prevention. Within these studies some possibilities, but no strictly defined rules of action for pharmacological or neuropsychological prevention are described. This is why in this randomized, double-blinded, placebo-controlled study, the investigators want to compare two agents that were found to prevent postoperative delirium to a certain level, even in combination: the investigators arrange the patients within four study groups, one receiving Haloperidol, one Ketamine, one both and one placebo. The patients receive the study drug only once right before induction of anesthesia. After the day of recruitment there is the day of operation and a follow-up of three days (5 days of observation in total, where the investigators will test cognitive function with Mini Mental Status Examination (MMSE), Delirium Observation Scale (DOS), Nursing Delirium Screening Scale (Nu-DESC) or Intensive Care Delirium Screening Checklist (ICDSC). Additionally the investigators will measure and compare pre- and postoperative Cortisol, NSE and S-100beta levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Haloperidol | Active comparator | Drug: HaloperidolHaloperidol 0.005mg/kg at induction of anesthesia |
| Ketamine | Active comparator | Drug: KetamineKetamine 1mg/kg at induction of anesthesia |
| Haloperidol + Ketamine | Active comparator | Drug: Haloperidol + KetamineCombination of Haloperidol + Ketamine in same dosage at induction of anesthesia |
| Saline solution (NaCl 0.9%) | Placebo comparator | Drug: Saline solution (NaCl 0.9%)Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years and older
- Signed agreement
Key exclusion criteria (14 listed)
- Delirium at admittance or MMSE score <24 points
- High risk for postoperative ICU treatment
- Haloperidol or Ketamine intolerance
- Risk of lack of cooperation
- Drug an alcohol abuse
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 |
|---|---|---|
| HaloperidolHaloperidol 0.005mg/kg at induction of anesthesia | Drug | Haloperidol |
| KetamineKetamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium | Drug | Ketamine |
| Haloperidol + KetamineHaloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together | Drug | Haloperidol + Ketamine |
| Saline solution (NaCl 0.9%)Placebo being used in one of the four groups | Drug | Saline solution (NaCl 0.9%) |
Primary outcome
Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days
Time frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
Significant drop in MMSE of two points in one of the three postoperative follow-up days (ICU patients excluded)
1 secondary outcome
Quantification of incidence of postoperative delirium based on cognitive testing and lab parameters
Time frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)
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 23 Jan 2019.
- Derived from this study: PubMed 33120302Hollinger A, Rust CA, Riegger H, Gysi B, Tran F, Brugger J, Huber J, Toft K, Surbeck M, Schmid HR, Rentsch K, Steiner L, Siegemund M. Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial. J Clin Anesth. 2021 Feb;68:110099. doi: 10.1016/j.jclinane.2020.110099. Epub 2020 Oct 22.
- Derived from this study: PubMed 29482596Riegger H, Hollinger A, Seifert B, Toft K, Blum A, Zehnder T, Siegemund M. Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe): a phase IV multicenter, randomized, placebo-controlled, double-blind clinical trial of ketamine versus haloperidol for prevention of postoperative delirium. Trials. 2018 Feb 26;19(1):142. doi: 10.1186/s13063-018-2498-6.
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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.
Alexa Hollinger, MD study director
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haloperidol, Ketamine and Haloperidol + Ketamine in people with Postoperative Delirium, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 14 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 23 Jan 2019. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Differences among study groups - Significant drop in MMSE of two points in one of the three postoperative follow-up days (time frame: 5 day follow-up (preoperative, day of surgery, postoperative days 1-3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02433041, which also lists 2 linked publications.
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 23 Jan 2019.