Postoperative Cognitive DysfunctionNCT07074262
Comparison Between the Effect of Dexmedetomidine _midazolam and ketamine_midazolam Combination
A study testing Ketamine in people with Postoperative Cognitive Dysfunction and Post Operative Delirium, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Postoperative cognitive dysfunction (POCD) is one of the most common complications after anesthesia, with a prevalence of approximately 12% and a higher prevalence of up to 41.4% in older surgical patients during the entire hospitalization period .A variety of pharmacological therapies are utilized to prevent or… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Post Operative Delirium
- What is being tested?
- Ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 10 Mar 2025
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (II - III) patients above 40 years old.
- Patients diagnosed with a cardiac condition (coronary artery disease, Valvular heart disease , arrhythmias, hypertension ) with EF > 40% and Moderate to good functional capacity (METS > 4).
- Patients scheduled to undergo low risk non-cardiac surgical procedures
Who cannot join
- Patients having gross hemodynamic or ventilatory fluctuations during the operation.
- Patients with recent myocardial infarction
- Patients who develop postoperative shock, major bleeding or complications.
- Patients with a history of psychiatric disorders.
- Patients with a current history of illicit drug use.
- Patients using hypnotic, anxiolytic, or antipsychotic drugs.
Show all 10Show fewer
- Allergy to any of the drugs that were used in the study.
- Emergency surgery of Moderate to high risk surgery.
- Pregnancy.
- Patient refusal to give consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni- Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62511
About this study
Official title: Comparison Between the Effect of Dexmedetomidine _midazolam and ketamine_midazolam Combination on Post Operative Delirium and Cognitive Disorders in Cardiac Patients Undergoing non_cardiac Surgery
Postoperative cognitive dysfunction (POCD) is one of the most common complications after anesthesia, with a prevalence of approximately 12% and a higher prevalence of up to 41.4% in older surgical patients during the entire hospitalization period .A variety of pharmacological therapies are utilized to prevent or minimize POCD.
Post-operative delirium is also one of the most common complications following anaesthesia with frequency estimates ranging from 10 to 50%. It is defined as delirium occurring 24 to 72 hours after surgery. There are multiple risk factors for developing postoperative delirium including pre-existing dementia, old age, medical co-morbidities, and psycopathological symptoms.
Read more
The recognition and treatment of Post-operative delirium is critically important because postoperative delirium is associated with poor outcomes including functional decline, dementia, cognitive impairment, increased hospital length of stay , increased mortality ( 11% increasing in the risk of death at 3 months and up to a 17% increased risk of death at 1 year. Previous studies have examined the relationship between patient-related factors, surgical factors and postoperative delirium.
Few studies have examined events in the postoperative period that may contribute to the occurrence of postoperative delirium. Two related and possibly modifiable factors in the postoperative period are postoperative pain and analgesic medications. Although prior studies suggest that postoperative pain and analgesia are associated with postoperative delirium.
Read the detailed description
POCD) is a subtle disorder of thought processes, which may influence isolated domains of cognition such as verbal memory, visual memory, language comprehension, visuospatial abstraction, attention, or concentration.It is to be distinguished from postoperative delirium, which tends to be a transient and fluctuating disturbance of consciousness that tends to occur shortly after surgery, whereas POCD is a more persistent problem of a change in cognitive performance as assessed by neuropsychological tests.
Delirium is defined by the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) as an acute and fluctuating disturbance in consciousness that may or may not be accompanied by agitation.Delirium has been reported to occur in 10% to 60% of surgical patients, however, the incidence of delirium in older surgical patients may be as high as 73% depending on the diagnostic method used.
Acute post-surgical pain leads to delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic persistent post-operative pain in almost half of the patients.
Acute postoperative pain remains one of the major challenges of pain medicine. Although various methods and drugs have been proposed to manage perioperative pain, oral and intravenous opioid analgesics are still among the most common medications. However, their potential short-and long-term adverse effects can limit their application.
Dexmedetomidine is an alpha-2 adrenoceptor agonist with analgesic and neuroprotec-tive effects. These neuroprotective characteristics may explain the growing evidence of the preventative effect of dexmedetomidine on POCD.
Ketamine, which is a dissociative anaesthetic, is having all the properties which we needed i.e. an intravenous anesthetic with distinct analgesic activity and relatively rapid onset of action with immediate recovery. The precise molecular mechanism of ketamine has been extensively studied during the last decade and the current understanding is that inhibition of sensory perception is mediated by the blockade of N-methyl D-aspartate receptor blockade.
- Being tested
- Ketamine
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Dexmedetomidine
to compare the effect of Ketamine versus Dexmedetomidine on postoperative cognitive dysfunction and delirium in all cardiac patient undergoing low risk non-cardic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | About 38 participants received conventional general anesthesia only. Smooth Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg IV - Midazolam 0.05 to 0.15 mg/kg(Dormicum 1mg/1m ampoul AMOUN com) to be titrated (and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2 %, and Mixture of O2 and Air (70%:30%). Receives: Drug: Ketamine |
| Ketamine group | Active comparator | About 38 participants received conventional general anesthesia with administration of Ketamine before induction as follow: Ketamine 1 mg /kg(ketalar Vial 50mg/ml pfzer com) will be administered IV before induction, then a smooth Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg(23) Midazolam 0.05 to 0.15 mg/kg to be titrated (24) and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2% and mixture of O2 and Air (70%: 30%). Receives: Drug: Ketamine |
| Dexmedetomidine group | Active comparator | About 38 participants received conventional general anesthesia with administration of dexmedetomidine before induction as follow:Dexmedetomidine(precedex 100mc/ml 1 mcg Pfizer com) will be injected IV before Induction of anesthesia. Then Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg(23), Midazolam 0.05 to 0.15 mg/kg to be titrated (24) and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2% and mixture of O2 and Air (70%: 30%). Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Cognitive Dysfunction and Delirium
Assessment of the patients whom subjected surgery by using Memorial delirium assessment scale (MDAS) as follows: 1, awareness; 2, orientation; 3, short-term memory; 4, digit span; 5, attention capacity; 6, organizational thinking; 7, perceptual disturbance; 8, delusions; 9, psychomotor activity; and 10, sleep-wake cycle
Measured: First 24 hours and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start10 Oct 2024
- Primary completion1 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Fathy Mohamed, Beni-Suef University
- Investigators
- Mahmoud Attia Nassef, Professor, Study chair, Anaesthesiology,Surgical intensive care and pain management,Faculty of Medicine,Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074262
- Sponsor's protocol ID
- Hanaa Fathy Mohamed
- Status last verified
- Oct 2024
- First submitted
- 25 Jun 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Dexmedetomidine _midazolam and ketamine_midazolam Combination on Post Operative Delirium and Cognitive Disorders in Cardiac Patients Undergoing non_cardiac Surgery
- ClinicalTrials.gov ID
- NCT07074262
- Acronym / sponsor ID
- Hanaa Fathy Mohamed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 20 Jul 2025 (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.
Postoperative cognitive dysfunction (POCD) is one of the most common complications after anesthesia, with a prevalence of approximately 12% and a higher prevalence of up to 41.4% in older surgical patients during the entire hospitalization period .A variety of pharmacological therapies are utilized to prevent or minimize POCD.
Post-operative delirium is also one of the most common complications following anaesthesia with frequency estimates ranging from 10 to 50%. It is defined as delirium occurring 24 to 72 hours after surgery. There are multiple risk factors for developing postoperative delirium including pre-existing dementia, old age, medical co-morbidities, and psycopathological symptoms.
The recognition and treatment of Post-operative delirium is critically important because postoperative delirium is associated with poor outcomes including functional decline, dementia, cognitive impairment, increased hospital length of stay , increased mortality ( 11% increasing in the risk of death at 3 months and up to a 17% increased risk of death at 1 year. Previous studies have examined the relationship between patient-related factors, surgical factors and postoperative delirium.
Few studies have examined events in the postoperative period that may contribute to the occurrence of postoperative delirium. Two related and possibly modifiable factors in the postoperative period are postoperative pain and analgesic medications. Although prior studies suggest that postoperative pain and analgesia are associated with postoperative delirium.
Detailed description
POCD) is a subtle disorder of thought processes, which may influence isolated domains of cognition such as verbal memory, visual memory, language comprehension, visuospatial abstraction, attention, or concentration.It is to be distinguished from postoperative delirium, which tends to be a transient and fluctuating disturbance of consciousness that tends to occur shortly after surgery, whereas POCD is a more persistent problem of a change in cognitive performance as assessed by neuropsychological tests.
Delirium is defined by the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) as an acute and fluctuating disturbance in consciousness that may or may not be accompanied by agitation.Delirium has been reported to occur in 10% to 60% of surgical patients, however, the incidence of delirium in older surgical patients may be as high as 73% depending on the diagnostic method used.
Acute post-surgical pain leads to delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic persistent post-operative pain in almost half of the patients.
Acute postoperative pain remains one of the major challenges of pain medicine. Although various methods and drugs have been proposed to manage perioperative pain, oral and intravenous opioid analgesics are still among the most common medications. However, their potential short-and long-term adverse effects can limit their application.
Dexmedetomidine is an alpha-2 adrenoceptor agonist with analgesic and neuroprotec-tive effects. These neuroprotective characteristics may explain the growing evidence of the preventative effect of dexmedetomidine on POCD.
Ketamine, which is a dissociative anaesthetic, is having all the properties which we needed i.e. an intravenous anesthetic with distinct analgesic activity and relatively rapid onset of action with immediate recovery. The precise molecular mechanism of ketamine has been extensively studied during the last decade and the current understanding is that inhibition of sensory perception is mediated by the blockade of N-methyl D-aspartate receptor blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: KetamineAbout 38 participants received conventional general anesthesia only. Smooth Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg IV - Midazolam 0.05 to 0.15 mg/kg(Dormicum 1mg/1m ampoul AMOUN com) to be titrated (and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2 %, and Mixture of O2 and Air (70%:30%). |
| Ketamine group | Active comparator | Drug: KetamineAbout 38 participants received conventional general anesthesia with administration of Ketamine before induction as follow: Ketamine 1 mg /kg(ketalar Vial 50mg/ml pfzer com) will be administered IV before induction, then a smooth Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg(23) Midazolam 0.05 to 0.15 mg/kg to be titrated (24) and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2% and mixture of O2 and Air (70%: 30%). |
| Dexmedetomidine group | Active comparator | Drug: KetamineAbout 38 participants received conventional general anesthesia with administration of dexmedetomidine before induction as follow:Dexmedetomidine(precedex 100mc/ml 1 mcg Pfizer com) will be injected IV before Induction of anesthesia. Then Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg(23), Midazolam 0.05 to 0.15 mg/kg to be titrated (24) and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2% and mixture of O2 and Air (70%: 30%). |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA (II - III) patients above 40 years old.
- Patients diagnosed with a cardiac condition (coronary artery disease, Valvular heart disease , arrhythmias, hypertension ) with EF > 40% and Moderate to good functional capacity (METS > 4).
- Patients scheduled to undergo low risk non-cardiac surgical procedures
Key exclusion criteria (10 listed)
- Patients having gross hemodynamic or ventilatory fluctuations during the operation.
- Patients with recent myocardial infarction
- Patients who develop postoperative shock, major bleeding or complications.
- Patients with a history of psychiatric disorders.
- Patients with a current history of illicit drug use.
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 |
|---|---|---|
| KetamineAlso: Dexmedetomidineto compare the effect of Ketamine versus Dexmedetomidine on postoperative cognitive dysfunction and delirium in all cardiac patient undergoing low risk non-cardic surgery. | Drug | Control Group, Dexmedetomidine group, Ketamine group |
Primary outcome
Postoperative Cognitive Dysfunction and Delirium
Time frame: First 24 hours and 48 hours after surgery
Assessment of the patients whom subjected surgery by using Memorial delirium assessment scale (MDAS) as follows: 1, awareness; 2, orientation; 3, short-term memory; 4, digit span; 5, attention capacity; 6, organizational thinking; 7, perceptual disturbance; 8, delusions; 9, psychomotor activity; and 10, sleep-wake cycle
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 20 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Cognitive Dysfunction
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Prediction and Prevention of Postoperative Mortality and Morbidity
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Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
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.
Mahmoud Attia Nassef, Professor study chair
Anaesthesiology,Surgical intensive care and pain management,Faculty of Medicine,Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Postoperative Cognitive Dysfunction and Post Operative Delirium, run by Beni-Suef 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 3 inclusion and 10 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 20 Jul 2025. 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. 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?
Postoperative Cognitive Dysfunction and Delirium (time frame: First 24 hours and 48 hours after surgery). 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 2025.