Delirium on EmergencePhase 4NCT04816162
Ketofol for Preventing Postoperative Delirium in Elderly Patients
A Phase 4 study testing ketofol, dexmedetomidine and normal saline in people with Delirium on Emergence, run by Zagazig University at 1 site in Egypt.
Trial summary
Delirium is a cognitive disturbance characterized by acute and fluctuating impairment in attention and awareness. Although its incidence in the general surgical population is 2-3%, it has been reported to occur in up to 10-80% of high-risk patient groups. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium on Emergence
- What is being tested?
- ketofol, dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2021to 1 Feb 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient acceptance.
- Age ≥ 60 years old.
- American society of anesthesia (ASA) (II-III).
- Gender: males \&females
- BMI < 35kg/m2.
- able to communicate verbally.
- Scheduled for exploration surgery for intestinal obstruction under general anesthesia of at least 60 min duration
Who cannot join
- Patient refusal.
- Patients with delirium prior to surgery.
- Patients with drug misuse history or taking anti-psychotic drugs.
- Previous hospitalization within 3 months.
- Legal blindness, severe deafness.
- History of Acute cerebrovascular conditions; stroke or transient ischemic attack.
Show all 9Show fewer
- Patients who could not be prepared with proper fluid resuscitation, electrolyte and acid-base correction prior to surgery.
- Patients who could be discharged from the intensive care unit (ICU) within two days.
- Patients with a known history of allergy to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketofol vs Dexmedetomidine for Preventing Post-operative Delirium in Elderly Patients Undergoing Intestinal Obstruction Surgeries. A Randomized Controlled Study
- Delirium is a cognitive disturbance characterized by acute and fluctuating impairment in attention and awareness. Although its incidence in the general surgical population is 2-3%, it has been reported to occur in up to 10-80% of high-risk patient groups. In addition, the occurrence of postoperative delirium is associated with considerably raised morbidity and mortality and increased healthcare resource expenditure.
- In the general patient population, no prophylactic pharmacologic treatment has shown widespread effectiveness in preventing delirium. Several studies have failed to find a magic pharmacologic bullet for preventing delirium-ketamine, haloperidol, propofol, antipsychotic and benzodiazepine drugs have recently tested without a clear result of its effectiveness.
- Dexmedetomidine is an attractive pharmacologic option because of its biological plausibility in modifying several known contributors to delirium.
- Up to investigators' knowledge, there is no study done to compare the effect of infusion of dexmedetomidine and ketofol mixture as prophylactic agents for high-risk patients as elderly patients who undergoing high-risk surgery such as intestinal obstruction surgery against postoperative delirium occurrence.
Read the detailed description
Small bowel obstruction (SBO) is one of the most frequent causes of general emergency surgery in elderly patients, approximately 10-12% of adult patients above 65 years presenting with acute abdominal pain at the emergency department (ED) is diagnosed as SBO. Small bowel obstruction is complicated with dehydration, malnutrition, electrolyte and acid-base disturbance, as well as insertion of many catheters as nasogastric tube, triple-lumen tube, and foley's catheter, besides multiple drugs intake due to the associated comorbidities; all of these factors increase the risk of developing POD ].
Delirium is defined as acute onset of fluctuating disturbance of consciousness with reduced ability to focus, alteration of attention, perceptual abnormalities, circadian disruption, a decline in cognitive function (orientation, memory speech, thinking), and psychomotor disturbances. POD commonly occurs between postoperative days 2-5, and it may be hypoactive, hyperactive, or mixed, based on psychomotor clinical features. The incidence rate of postoperative delirium(POD) varies between 9% and 87% in elderly patients, depending on the patients' population and degree of operative stress.
Postoperative delirium develops in the elderly due to multiple risk factors that can be separated into patient-related and operation-related risk factors. Established patient-specific risk factors include pre-existing dementia (appears to be the strongest predictor for the occurrence of POD), older age, functional impairment, greater co-morbidities, and psychopathological symptoms. Operation-specific risk factors for POD are based on the degree of operative stress, any type of iatrogenic event including medication adverse effects (Common drugs that may precipitate delirium in the elderly include antihistamines, anticholinergics, chemotherapeutic agents, dopamine agonists, benzodiazepines, opioid analgesics, steroids, and psychostimulants), physical restraint, urinary catheterization, hospital-acquired infection, dehydration and malnutrition, and admission to the intensive care unit (ICU). The risk factors for developing POD are additive therefore, recognizing those with multiple risk factors should trigger environmental and supportive measures implementation that have been proven to prevent the onset and shorten the duration of POD because POD is associated with poor outcomes such as functional decline, longer hospitalization, greater costs, a greater need for rehabilitation and home healthcare services after discharge and higher mortality.
Ketofol which is a mixture of ketamine and propofol gains increasing interest as an agent for procedural sedation and analgesia for producing a more stable hemodynamic and respiratory profile as Ketamine and propofol appear to counter each other's adverse effects; sympathomimetic effects of ketamine and dose-dependent hypotension and respiratory depression of propofol. Ketofol has been used in different mixed ratios (1:1-1:10) and has proven effective in reducing postoperative agitation in children in several studies as well.
Dexmedetomidine, a highly selective alpha-2 adrenoreceptor (α2) agonist, has been widely used in surgical patients and has positive sedation, anti-anxiety, and analgesic effects. The mechanism of action of dexmedetomidine is unique compared with traditionally administered sedative agents due to its lack of activity at the gamma-aminobutyric acid (GABA) receptor and missing anticholinergic activity.1that may contribute to pathophysiological explanations of the development of delirium 'neurotransmitter hypothesis' and include dysfunction of cholinergic transmission.
The investigators hypothesized that administration of ketofol following induction of general anesthesia, would reduce the incidence of emergence delirium and postoperative delirium, and has a comparable effect to dexmedetomidine on investigators' groups of high-risk elderly patients undergoing urgent exploration of intestinal obstruction.
- Conditions
- Delirium on Emergence
- Being tested
- ketofol, dexmedetomidine, normal saline
- Keywords
- ketofol, dexmedetomidine, post operative delirium, elderly patients
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketofolDrug
Also called a mixture of propofol and ketamine
prepared in a ratio of (1:4) respectively), where 1ml of ketamine will be added to 20 ml of propofol in a syringe pump
dexmedetomidineDrug
Also called precedex
2 ml (200 µg) of dexmedetomidine added to 0.9% normal saline in a syringe pump
normal salineOther
normal saline 0.9% in a syringe pump
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 21 ml of normal saline 0.9% will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively. Receives: Other: normal saline |
| ketofol group | Active comparator | 21 ml of a mixture of (ketamine and propofol) will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively Receives: Drug: ketofol |
| dexmedetomidine group | Active comparator | 21 ml of a mixture of (dexmedetomidine diluted with normal saline 0.9%) will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post operative delirium
Patients will be assessed for postoperative delirium using Confusion Assessment Method (CAM), or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Measured: up to first three postoperative days
Secondary outcomes (2)
changes of pain assessment
Visual analogue scale
Measured: 30 minutes, 1 hour, 2, 4, 18, 12, 24 hours postoperatively
changes of hemodynamics
by non invasive blood pressure
Measured: immediately prior to surgery, intraoperative (after starting infusion of study drug, then every 10 minute till end of surgery), later on they will be measured every 15 min postoperatively up to two hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start25 Mar 2021
- Primary completion1 Nov 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Delirium on EmergenceStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Parallel groups
- Model description
- A computer-generated table will be used to divide patients equally into three study groups * In group C (control group):21 ml of normal saline 0.9% will be I.V infused at a rate of 0.3-0.4 mg/kg/h to the patient. * In group K: ketofol (a mixture of ketamine and propofol will be prepared in a ratio of (1:4) respectively), will be I.V infused at a rate of 0.3-0.4 mg/kg/h to the patient. * In group D: adding dexmedetomidine 2 ml (200 µg) to 19 ml of 0.9% normal saline to start I.V infusion to the patient
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
- Investigators
- Shereen E Abd Ellatif, MD, Principal investigator, faculty of human medicine,zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816162
- Sponsor's protocol ID
- 6704/10-3-2021
- Status last verified
- Jul 2023
- First submitted
- 22 Mar 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Spangler R, Van Pham T, Khoujah D, Martinez JP. Abdominal emergencies in the geriatric patient. Int J Emerg Med. 2014 Oct 21;7:43. doi: 10.1186/s12245-014-0043-2. eCollection 2014.
PubMed 25635203Ozturk E, van Iersel M, Stommel MM, Schoon Y, Ten Broek RR, van Goor H. Small bowel obstruction in the elderly: a plea for comprehensive acute geriatric care. World J Emerg Surg. 2018 Oct 20;13:48. doi: 10.1186/s13017-018-0208-z. eCollection 2018.
PubMed 30377439Dale O, Somogyi AA, Li Y, Sullivan T, Shavit Y. Does intraoperative ketamine attenuate inflammatory reactivity following surgery? A systematic review and meta-analysis. Anesth Analg. 2012 Oct;115(4):934-43. doi: 10.1213/ANE.0b013e3182662e30. Epub 2012 Jul 23.
PubMed 22826531Maldonado JR, Wysong A, van der Starre PJ, Block T, Miller C, Reitz BA. Dexmedetomidine and the reduction of postoperative delirium after cardiac surgery. Psychosomatics. 2009 May-Jun;50(3):206-17. doi: 10.1176/appi.psy.50.3.206.
PubMed 19567759Li WX, Luo RY, Chen C, Li X, Ao JS, Liu Y, Yin YQ. Effects of propofol, dexmedetomidine, and midazolam on postoperative cognitive dysfunction in elderly patients: a randomized controlled preliminary trial. Chin Med J (Engl). 2019 Feb;132(4):437-445. doi: 10.1097/CM9.0000000000000098.
PubMed 30707179Smischney NJ, Hoskote SS, Gallo de Moraes A, Racedo Africano CJ, Carrera PM, Tedja R, Pannu JK, Hassebroek EC, Reddy DR, Hinds RF, Thakur L. Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial. Trials. 2015 Apr 21;16:177. doi: 10.1186/s13063-015-0687-0.
PubMed 25909406Abd Ellatif SE, Mowafy SMS, Shahin MA. Ketofol versus Dexmedetomidine for preventing postoperative delirium in elderly patients undergoing intestinal obstruction surgeries: a randomized controlled study. BMC Anesthesiol. 2024 Jan 2;24(1):1. doi: 10.1186/s12871-023-02378-5.
PubMed 38166598
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketofol vs Dexmedetomidine for Preventing Post-operative Delirium in Elderly Patients Undergoing Intestinal Obstruction Surgeries. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04816162
- Acronym / sponsor ID
- 6704/10-3-2021
- Conditions
- Delirium on Emergence
- Keywords
- ketofol, dexmedetomidine, post operative delirium, elderly patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 25 Mar 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.
- Delirium is a cognitive disturbance characterized by acute and fluctuating impairment in attention and awareness. Although its incidence in the general surgical population is 2-3%, it has been reported to occur in up to 10-80% of high-risk patient groups. In addition, the occurrence of postoperative delirium is associated with considerably raised morbidity and mortality and increased healthcare resource expenditure.
- In the general patient population, no prophylactic pharmacologic treatment has shown widespread effectiveness in preventing delirium. Several studies have failed to find a magic pharmacologic bullet for preventing delirium-ketamine, haloperidol, propofol, antipsychotic and benzodiazepine drugs have recently tested without a clear result of its effectiveness.
- Dexmedetomidine is an attractive pharmacologic option because of its biological plausibility in modifying several known contributors to delirium.
- Up to investigators' knowledge, there is no study done to compare the effect of infusion of dexmedetomidine and ketofol mixture as prophylactic agents for high-risk patients as elderly patients who undergoing high-risk surgery such as intestinal obstruction surgery against postoperative delirium occurrence.
Detailed description
Small bowel obstruction (SBO) is one of the most frequent causes of general emergency surgery in elderly patients, approximately 10-12% of adult patients above 65 years presenting with acute abdominal pain at the emergency department (ED) is diagnosed as SBO. Small bowel obstruction is complicated with dehydration, malnutrition, electrolyte and acid-base disturbance, as well as insertion of many catheters as nasogastric tube, triple-lumen tube, and foley's catheter, besides multiple drugs intake due to the associated comorbidities; all of these factors increase the risk of developing POD ].
Delirium is defined as acute onset of fluctuating disturbance of consciousness with reduced ability to focus, alteration of attention, perceptual abnormalities, circadian disruption, a decline in cognitive function (orientation, memory speech, thinking), and psychomotor disturbances. POD commonly occurs between postoperative days 2-5, and it may be hypoactive, hyperactive, or mixed, based on psychomotor clinical features. The incidence rate of postoperative delirium(POD) varies between 9% and 87% in elderly patients, depending on the patients' population and degree of operative stress.
Postoperative delirium develops in the elderly due to multiple risk factors that can be separated into patient-related and operation-related risk factors. Established patient-specific risk factors include pre-existing dementia (appears to be the strongest predictor for the occurrence of POD), older age, functional impairment, greater co-morbidities, and psychopathological symptoms. Operation-specific risk factors for POD are based on the degree of operative stress, any type of iatrogenic event including medication adverse effects (Common drugs that may precipitate delirium in the elderly include antihistamines, anticholinergics, chemotherapeutic agents, dopamine agonists, benzodiazepines, opioid analgesics, steroids, and psychostimulants), physical restraint, urinary catheterization, hospital-acquired infection, dehydration and malnutrition, and admission to the intensive care unit (ICU). The risk factors for developing POD are additive therefore, recognizing those with multiple risk factors should trigger environmental and supportive measures implementation that have been proven to prevent the onset and shorten the duration of POD because POD is associated with poor outcomes such as functional decline, longer hospitalization, greater costs, a greater need for rehabilitation and home healthcare services after discharge and higher mortality.
Ketofol which is a mixture of ketamine and propofol gains increasing interest as an agent for procedural sedation and analgesia for producing a more stable hemodynamic and respiratory profile as Ketamine and propofol appear to counter each other's adverse effects; sympathomimetic effects of ketamine and dose-dependent hypotension and respiratory depression of propofol. Ketofol has been used in different mixed ratios (1:1-1:10) and has proven effective in reducing postoperative agitation in children in several studies as well.
Dexmedetomidine, a highly selective alpha-2 adrenoreceptor (α2) agonist, has been widely used in surgical patients and has positive sedation, anti-anxiety, and analgesic effects. The mechanism of action of dexmedetomidine is unique compared with traditionally administered sedative agents due to its lack of activity at the gamma-aminobutyric acid (GABA) receptor and missing anticholinergic activity.1that may contribute to pathophysiological explanations of the development of delirium 'neurotransmitter hypothesis' and include dysfunction of cholinergic transmission.
The investigators hypothesized that administration of ketofol following induction of general anesthesia, would reduce the incidence of emergence delirium and postoperative delirium, and has a comparable effect to dexmedetomidine on investigators' groups of high-risk elderly patients undergoing urgent exploration of intestinal obstruction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A computer-generated table will be used to divide patients equally into three study groups * In group C (control group):21 ml of normal saline 0.9% will be I.V infused at a rate of 0.3-0.4 mg/kg/h to the patient. * In group K: ketofol (a mixture of ketamine and propofol will be prepared in a ratio of (1:4) respectively), will be I.V infused at a rate of 0.3-0.4 mg/kg/h to the patient. * In group D: adding dexmedetomidine 2 ml (200 µg) to 19 ml of 0.9% normal saline to start I.V infusion to the patient
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: normal saline21 ml of normal saline 0.9% will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively. |
| ketofol group | Active comparator | Drug: ketofol21 ml of a mixture of (ketamine and propofol) will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively |
| dexmedetomidine group | Active comparator | Drug: dexmedetomidine21 ml of a mixture of (dexmedetomidine diluted with normal saline 0.9%) will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient acceptance.
- Age ≥ 60 years old.
- American society of anesthesia (ASA) (II-III).
- Gender: males \&females
- BMI < 35kg/m2.
Key exclusion criteria (9 listed)
- Patient refusal.
- Patients with delirium prior to surgery.
- Patients with drug misuse history or taking anti-psychotic drugs.
- Previous hospitalization within 3 months.
- Legal blindness, severe deafness.
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 |
|---|---|---|
| ketofolAlso: a mixture of propofol and ketamineprepared in a ratio of (1:4) respectively), where 1ml of ketamine will be added to 20 ml of propofol in a syringe pump | Drug | ketofol group |
| dexmedetomidineAlso: precedex2 ml (200 µg) of dexmedetomidine added to 0.9% normal saline in a syringe pump | Drug | dexmedetomidine group |
| normal salinenormal saline 0.9% in a syringe pump | Other | Control group |
Primary outcome
incidence of post operative delirium
Time frame: up to first three postoperative days
Patients will be assessed for postoperative delirium using Confusion Assessment Method (CAM), or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
2 secondary outcomes
changes of pain assessment
Time frame: 30 minutes, 1 hour, 2, 4, 18, 12, 24 hours postoperatively
changes of hemodynamics
Time frame: immediately prior to surgery, intraoperative (after starting infusion of study drug, then every 10 minute till end of surgery), later on they will be measured every 15 min postoperatively up to two hours postoperatively
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 1 Aug 2023.
- Background: PubMed 25635203Spangler R, Van Pham T, Khoujah D, Martinez JP. Abdominal emergencies in the geriatric patient. Int J Emerg Med. 2014 Oct 21;7:43. doi: 10.1186/s12245-014-0043-2. eCollection 2014.
- Background: PubMed 30377439Ozturk E, van Iersel M, Stommel MM, Schoon Y, Ten Broek RR, van Goor H. Small bowel obstruction in the elderly: a plea for comprehensive acute geriatric care. World J Emerg Surg. 2018 Oct 20;13:48. doi: 10.1186/s13017-018-0208-z. eCollection 2018.
- Background: PubMed 22826531Dale O, Somogyi AA, Li Y, Sullivan T, Shavit Y. Does intraoperative ketamine attenuate inflammatory reactivity following surgery? A systematic review and meta-analysis. Anesth Analg. 2012 Oct;115(4):934-43. doi: 10.1213/ANE.0b013e3182662e30. Epub 2012 Jul 23.
- Background: PubMed 19567759Maldonado JR, Wysong A, van der Starre PJ, Block T, Miller C, Reitz BA. Dexmedetomidine and the reduction of postoperative delirium after cardiac surgery. Psychosomatics. 2009 May-Jun;50(3):206-17. doi: 10.1176/appi.psy.50.3.206.
- Background: PubMed 30707179Li WX, Luo RY, Chen C, Li X, Ao JS, Liu Y, Yin YQ. Effects of propofol, dexmedetomidine, and midazolam on postoperative cognitive dysfunction in elderly patients: a randomized controlled preliminary trial. Chin Med J (Engl). 2019 Feb;132(4):437-445. doi: 10.1097/CM9.0000000000000098.
- Background: PubMed 25909406Smischney NJ, Hoskote SS, Gallo de Moraes A, Racedo Africano CJ, Carrera PM, Tedja R, Pannu JK, Hassebroek EC, Reddy DR, Hinds RF, Thakur L. Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial. Trials. 2015 Apr 21;16:177. doi: 10.1186/s13063-015-0687-0.
- Derived from this study: PubMed 38166598Abd Ellatif SE, Mowafy SMS, Shahin MA. Ketofol versus Dexmedetomidine for preventing postoperative delirium in elderly patients undergoing intestinal obstruction surgeries: a randomized controlled study. BMC Anesthesiol. 2024 Jan 2;24(1):1. doi: 10.1186/s12871-023-02378-5.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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.
Shereen E Abd Ellatif, MD principal investigator
faculty of human medicine,zagazig university
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 ketofol, dexmedetomidine and normal saline in people with Delirium on Emergence, run by Zagazig University at 1 site in Egypt.
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 7 inclusion and 9 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 1 Aug 2023. 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 Egypt. 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?
incidence of post operative delirium (time frame: up to first three postoperative days). 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 NCT04816162, which also lists 7 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 1 Aug 2023.