Lower Extremity ProblemNCT03251651
Intraoperative Sedatives and Postoperative Deilirium
A study testing Propofol and Dexmedetomidine in people with Lower Extremity Problem and Delirium, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive, and mixed. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Lower Extremity Problem, Delirium, Propofol
- What is being tested?
- Propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 748 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2017to 15 Oct 2021
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who undergo orthopedic surgery under spinal anesthesia
- Patients who want to sedation during the surgery
- Age of 65 years or greater
- American Society of Anesthesiologists physical status classification 1 and 2
Who cannot join
- General anesthesia
- Age < 65 years
- Patients who do not want to sedation during the surgery
- Patients who do not receive patient controlled analgesia postoperatively.
- Cognitive disorders
- Central nervous system disease, including dementia and Parkinson's disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: The Incidence of Postoperative Delirium According to the Different Intraoperative Sedatives, Dexmedetomidine vs. Propofol, in Elderly Patients Undergoing Orthopedic Lower Limb Surgery With Spinal Anesthesia: A Randomized Trial
Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive, and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is important to promptly manage such behaviors associated with hyperactive delirium. Intraoperative sedation plays an important role in relieving anxiety or stress response of patients. Propofol-a common sedative agent-was reported to cause delirium more frequently, compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU sedation or procedural sedation. However, there has not been any prospective randomized study investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study, based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence of abnormal psycho-motor behavior compared with propofol sedation, investigators prospectively will investigate the incidence of postoperative delirium in elderly patients who undergo orthopedic surgery with regional anesthesia.
- Conditions
- Lower Extremity Problem, Delirium, Propofol, Dexmedetomidine
- Being tested
- Propofol, Dexmedetomidine
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0 μg/ml.
DexmedetomidineDrug
Dexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml. As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| PPF | Experimental | Patient who received propofol during the operation Receives: Drug: Propofol |
| DEX | Experimental | Patient who received dexmedetomidine during the operation Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
The incidence of postoperative delirium
Measured: Within 3 day postoperatively
Secondary outcomes (9)
Numerical rating scale
Postoperative pain score
Measured: Postoperative 24 hour
Numerical rating scale
Postoperative pain score
Measured: Postoperative 48 hour
Numerical rating scale
Postoperative pain score
Measured: Postoperative 72 hour
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Measured: Postoperative 24 hour
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Measured: Postoperative 48 hour
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Measured: Postoperative 72 hour
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Measured: Postoperative 24 hour
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Measured: postoperative 48 hour
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Measured: Postoperative 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start15 Jun 2017
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity ProblemStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
- Investigators
- Hyo-Seok Na, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251651
- Sponsor's protocol ID
- B-1704/391-304
- Status last verified
- Jul 2022
- First submitted
- 14 Aug 2017
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Postoperative Delirium According to the Different Intraoperative Sedatives, Dexmedetomidine vs. Propofol, in Elderly Patients Undergoing Orthopedic Lower Limb Surgery With Spinal Anesthesia: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03251651
- Acronym / sponsor ID
- B-1704/391-304
- Conditions
- Lower Extremity Problem, Delirium, Propofol, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 16 Aug 2017 (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 occurs commonly in elderly patients. Its incidence after orthopedic surgery has been reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive, and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is important to promptly manage such behaviors associated with hyperactive delirium. Intraoperative sedation plays an important role in relieving anxiety or stress response of patients. Propofol-a common sedative agent-was reported to cause delirium more frequently, compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU sedation or procedural sedation. However, there has not been any prospective randomized study investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study, based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence of abnormal psycho-motor behavior compared with propofol sedation, investigators prospectively will investigate the incidence of postoperative delirium in elderly patients who undergo orthopedic surgery with regional anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPF | Experimental | Drug: PropofolPatient who received propofol during the operation |
| DEX | Experimental | Drug: DexmedetomidinePatient who received dexmedetomidine during the operation |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients who undergo orthopedic surgery under spinal anesthesia
- Patients who want to sedation during the surgery
- Age of 65 years or greater
- American Society of Anesthesiologists physical status classification 1 and 2
Key exclusion criteria (6 listed)
- General anesthesia
- Age < 65 years
- Patients who do not want to sedation during the surgery
- Patients who do not receive patient controlled analgesia postoperatively.
- Cognitive disorders
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 |
|---|---|---|
| PropofolPropofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0 μg/ml. | Drug | PPF |
| DexmedetomidineDexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml. As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h. | Drug | DEX |
Primary outcome
Postoperative delirium
Time frame: Within 3 day postoperatively
The incidence of postoperative delirium
9 secondary outcomes
Numerical rating scale
Time frame: Postoperative 24 hour
Numerical rating scale
Time frame: Postoperative 48 hour
Numerical rating scale
Time frame: Postoperative 72 hour
Patient controlled analgesia (PCA)
Time frame: Postoperative 24 hour
Patient controlled analgesia (PCA)
Time frame: Postoperative 48 hour
Patient controlled analgesia (PCA)
Time frame: Postoperative 72 hour
Rescue analgesics
Time frame: Postoperative 24 hour
Rescue analgesics
Time frame: postoperative 48 hour
Rescue analgesics
Time frame: Postoperative 72 hour
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 11 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Hyo-Seok Na, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Dexmedetomidine in people with Lower Extremity Problem and Delirium, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 4 inclusion and 6 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 11 Jul 2022. 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 South Korea. 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 delirium (time frame: Within 3 day postoperatively). 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 11 Jul 2022.