Post Operative DeliriumNCT06614881
Dexmedetomidine Dosage for Postoperative Delirium and Cognitive Function in Elderly TKA Patients
A study testing Dexmedetomidine Injection [Precedex], Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) and Normal saline in people with Post Operative Delirium, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Post Operative Delirium
- What is being tested?
- Dexmedetomidine Injection [Precedex], Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Nov 2024
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Severe chronic knee osteoarthritis inducing limitation of movement and required knee replacements;
- Patients of American Society of Anesthesiologists Classification grades II-III;
- Patients free of exclusion criteria.
Who cannot join
- Patients of American Society of Anesthesiologists Classification grade >III;
- Patients show a high risk for getting Post Operative Delirium or have severe cognitive dysfunction;
- Patients had a history of uncompensated cardiac, renal, or hepatic diseases;
- Patients had uncontrolled diabetes mellitus or hypertension;
- Patients had other causes for limited movement;
- Patients had autoimmune disease, coagulopathy, severe anemia with a hemoglobin concentration of <7 g%;
- Patients had local bone disorders that may prevent prosthesis stability;
- Patients had allergies or contraindications to the study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Effective Dose of Dexmedetomidine on Postoperative Delirium and Cognitive Function of Elderly Patients Planned For TKA Surgery
This study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (TKA). The study will compare the outcomes of patients receiving dexmedetomidine to those receiving a standard anesthetic or sedative, focusing on factors such as patient characteristics, surgical duration, and postoperative care. The research will explore the potential neuroprotective effects of dexmedetomidine and its ability to mitigate the risks associated with anesthesia and surgery in vulnerable elderly populations.
- Conditions
- Post Operative Delirium
- Being tested
- Dexmedetomidine Injection [Precedex], Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML), Normal saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Injection [Precedex]Drug
Dexmedetomidine (Precedex, 100 µg/ml) was provided as an intravenous (IV) loading dose of 1 µg/kg over 10-min
Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Drug
Dexmedetomidine infusions were prepared to provide 0.5 µg/kg/h
Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Drug
Dexmedetomidine infusions were prepared to provide 0.7 µg/kg/h
Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Drug
Dexmedetomidine infusions were prepared to provide 1.1 µg/kg/h
Normal salineDrug
loading dose of saline was injected 10-min before induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Not described Receives: Drug: Normal saline |
| Group D-1 | Active comparator | Not described Receives: Drug: Dexmedetomidine Injection [Precedex]; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) |
| Group D-2 | Active comparator | Not described Receives: Drug: Dexmedetomidine Injection [Precedex]; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) |
| Group D-3 | Active comparator | Not described Receives: Drug: Dexmedetomidine Injection [Precedex]; Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reporting at least a 50% reduction of Postoperative Delirium (measured by Confusion Assessment Method, Delirium Index) post-Total knee arthroplasty under sevoflurane inhalational anesthesia.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Jul 2024
- Primary completion15 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative DeliriumStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed B. Abo elkheer, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614881
- Sponsor's protocol ID
- 36264PR790/7/24
- Status last verified
- Nov 2024
- First submitted
- 24 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Effective Dose of Dexmedetomidine on Postoperative Delirium and Cognitive Function of Elderly Patients Planned For TKA Surgery
- ClinicalTrials.gov ID
- NCT06614881
- Acronym / sponsor ID
- 36264PR790/7/24
- Conditions
- Post Operative Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 26 Sep 2024 (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.
This study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (TKA). The study will compare the outcomes of patients receiving dexmedetomidine to those receiving a standard anesthetic or sedative, focusing on factors such as patient characteristics, surgical duration, and postoperative care. The research will explore the potential neuroprotective effects of dexmedetomidine and its ability to mitigate the risks associated with anesthesia and surgery in vulnerable elderly populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Normal saline |
| Group D-1 | Active comparator | Drug: Dexmedetomidine Injection [Precedex], Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) |
| Group D-2 | Active comparator | Drug: Dexmedetomidine Injection [Precedex], Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) |
| Group D-3 | Active comparator | Drug: Dexmedetomidine Injection [Precedex], Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Severe chronic knee osteoarthritis inducing limitation of movement and required knee replacements;
- Patients of American Society of Anesthesiologists Classification grades II-III;
- Patients free of exclusion criteria.
Key exclusion criteria (8 listed)
- Patients of American Society of Anesthesiologists Classification grade >III;
- Patients show a high risk for getting Post Operative Delirium or have severe cognitive dysfunction;
- Patients had a history of uncompensated cardiac, renal, or hepatic diseases;
- Patients had uncontrolled diabetes mellitus or hypertension;
- Patients had other causes for limited movement;
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 |
|---|---|---|
| Dexmedetomidine Injection [Precedex]Dexmedetomidine (Precedex, 100 µg/ml) was provided as an intravenous (IV) loading dose of 1 µg/kg over 10-min | Drug | Group D-1, Group D-2, Group D-3 |
| Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Dexmedetomidine infusions were prepared to provide 0.5 µg/kg/h | Drug | Group D-1 |
| Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Dexmedetomidine infusions were prepared to provide 0.7 µg/kg/h | Drug | Group D-2 |
| Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)Dexmedetomidine infusions were prepared to provide 1.1 µg/kg/h | Drug | Group D-3 |
| Normal salineloading dose of saline was injected 10-min before induction of anesthesia. | Drug | Control Group |
Primary outcome
Proportion of patients reporting at least a 50% reduction of Postoperative Delirium (measured by Confusion Assessment Method, Delirium Index) post-Total knee arthroplasty under sevoflurane inhalational anesthesia.
Time frame: 3 months
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 26 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine Injection [Precedex], Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) and Normal saline in people with Post Operative Delirium, run by Tanta 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 8 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 26 Nov 2024. 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.
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?
Proportion of patients reporting at least a 50% reduction of Postoperative Delirium (measured by Confusion Assessment Method, Delirium Index) post-Total knee arthroplasty under sevoflurane inhalational anesthesia. (time frame: 3 months). 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 26 Nov 2024.