Postoperative Cognitive DysfunctionPhase 4CODE-POCDNCT06371638
Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD)
A Phase 4 study testing Dexmedetomidine and Sevoflurane in people with Postoperative Cognitive Dysfunction and Postoperative Pain, run by Udayana University at 1 site in Indonesia.
Trial summary
Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Pain
- What is being tested?
- Dexmedetomidine and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Jan 2024to 7 Mar 2024
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >= 18 years old
- Scheduled for laparatomy surgery
Who cannot join
- history of allergies to anaesthetic drugs
- impaired consciousness
- neurocognitive disorder
- psychiatric disorder
- mental disorder
- cerebrovascular disorders
Show all 11Show fewer
- sick sinus syndrome
- hypoalbuminemia
- massive bleeding
- liver disease
- kidney diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Dexmedetomidine Infusion Reduces Postoperative Cognitive Dysfunction and Postoperative Pain in Patients Undergoing Laparatomy
Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane.
- Being tested
- Dexmedetomidine, Sevoflurane
- Keywords
- postoperative cognitive complications, dexmedetomidine, pain, hemodynamics
- Medical subject headings
- Postoperative Cognitive Complications, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Group D
General anaesthesia for subjects in Group D was maintained by target-controlled infusion (TCI) dexmedetomidine (Dyck mode) with target plasma of 1 ng/ml
SevofluraneDrug
Also called Group I
General anaesthesia for subjects in Group I was maintained by inhalation anaesthesia using sevoflurane at 0.8% concentration.
| Study group | Role | What they receive |
|---|---|---|
| Patients with POCD | Experimental | MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score. Receives: Drug: Dexmedetomidine; Drug: Sevoflurane |
| Patients without POCD | Active comparator | MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score. Receives: Drug: Dexmedetomidine; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive dysfunction (POCD)
Assessed by Mini-Mental State Examination (MMSE). Defined if there is a >= 2 points decrease compared to baseline.
Measured: 48 hours postoperative
Postoperative cognitive dysfunction (POCD)
Assessed by Mini-Mental State Examination (MMSE). Defined if there is a >= 2 points decrease compared to baseline.
Measured: 30 days postoperative
Secondary outcomes (5)
Intraoperative hemodynamics: mean arterial pressure (MAP)
MAP as presented by intraoperative standard monitoring
Measured: During the course of intraoperative period.
Intraoperative hemodynamics: heart rate (HR)
HR as presented by intraoperative standard monitoring
Measured: During the course of intraoperative period.
Postoperative pain
Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)
Measured: 1 hour postoperative
Postoperative pain
Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)
Measured: 12 hours postoperative
Postoperative pain
Assessed by visual analog scale (VAS), minimum value=0 (no pain), maximum=10 (worst pain)
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start7 Jan 2024
- Primary completion1 Mar 2024
- Study completion7 Mar 2024
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, MD, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371638
- Sponsor's protocol ID
- 2024-01
- Acronym
- CODE-POCD
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available for other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Dexmedetomidine Infusion Reduces Postoperative Cognitive Dysfunction and Postoperative Pain in Patients Undergoing Laparatomy
- ClinicalTrials.gov ID
- NCT06371638
- Acronym / sponsor ID
- CODE-POCD / 2024-01
- Keywords
- postoperative cognitive complications, dexmedetomidine, pain, hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 17 Apr 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.
Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with POCD | Experimental | Drug: Dexmedetomidine, Drug: SevofluraneMMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score. |
| Patients without POCD | Active comparator | Drug: Dexmedetomidine, Drug: SevofluraneMMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged >= 18 years old
- Scheduled for laparatomy surgery
Key exclusion criteria (11 listed)
- history of allergies to anaesthetic drugs
- impaired consciousness
- neurocognitive disorder
- psychiatric disorder
- mental disorder
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 |
|---|---|---|
| DexmedetomidineAlso: Group DGeneral anaesthesia for subjects in Group D was maintained by target-controlled infusion (TCI) dexmedetomidine (Dyck mode) with target plasma of 1 ng/ml | Drug | Patients with POCD, Patients without POCD |
| SevofluraneAlso: Group IGeneral anaesthesia for subjects in Group I was maintained by inhalation anaesthesia using sevoflurane at 0.8% concentration. | Drug | Patients with POCD, Patients without POCD |
Primary outcome
Postoperative cognitive dysfunction (POCD)
Time frame: 48 hours postoperative
Assessed by Mini-Mental State Examination (MMSE). Defined if there is a >= 2 points decrease compared to baseline.
Postoperative cognitive dysfunction (POCD)
Time frame: 30 days postoperative
Assessed by Mini-Mental State Examination (MMSE). Defined if there is a >= 2 points decrease compared to baseline.
5 secondary outcomes
Intraoperative hemodynamics: mean arterial pressure (MAP)
Time frame: During the course of intraoperative period.
Intraoperative hemodynamics: heart rate (HR)
Time frame: During the course of intraoperative period.
Postoperative pain
Time frame: 1 hour postoperative
Postoperative pain
Time frame: 12 hours postoperative
Postoperative pain
Time frame: 24 hours postoperative
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 19 Apr 2024.
- Individual participant dataSharing planned: Yes. Data is available for other researchers upon request.
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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 Phase 4 study testing Dexmedetomidine and Sevoflurane in people with Postoperative Cognitive Dysfunction and Postoperative Pain, run by Udayana University at 1 site in Indonesia.
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 11 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 19 Apr 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 Indonesia. 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.
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?
Postoperative cognitive dysfunction (POCD) (time frame: 48 hours postoperative). 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 19 Apr 2024.