Postoperative DeliriumNCT03120442
Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia
A study testing Propofol, Dexmedetomidine and Fentanyl in people with Postoperative Delirium, run by Mahidol University at 1 site in Thailand.
Trial summary
Postoperative delirium after total knee replacement surgery has been related to significant morbidity and mortality among high risk patients. Anesthetic care might play a role in the development of postoperative delirium. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Propofol, Dexmedetomidine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteThailand
- Study dates
- 14 Jun 2017to Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 year or older
- Scheduled for elective primary total knee arthroplasty
Who cannot join
- Contraindication for spinal anesthesia
- Contraindication for adductor canal block
- Allergy to fentanyl or propofol or dexmedetomidine or bupivacaine
- Cognitive impairment
- NSQIP database risk calculator > 10% overall complication
- Unable to communicate in Thai language
- Significant visual and hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia: a Comparison Between Intraoperative Sedation With Fentanyl, Fentanyl-dexmedetomidine and Fentanyl-propofol
Postoperative delirium after total knee replacement surgery has been related to significant morbidity and mortality among high risk patients. Anesthetic care might play a role in the development of postoperative delirium.
The purpose of this study is to compare the incidence of postoperative delirium between different intraoperative sedation regimen. Delirium assessment using standardized screening tools will be done every 8 hours after surgery.
Read the detailed description
- In this randomized controlled trial, the investigator will compare the incidence of postoperative delirium after total knee arthroplasty between 3 intraoperative sedation regimens including (1) propofol-fentanyl (2) dexmedetomidine -fentanyl (3) fentanyl alone
- Anesthesia techniques include spinal anesthesia and adductor canal block for postoperative analgesia. Sedation will be provide per group assignment.
- After performance of regional anesthesia, sedation protocols will be used as followed: (1) target-controlled infusion of Propofol to achieve MOAA/S of 3-4 (2) incremental titration of Dexmedetomidine to achieve MOAA/S of 3-4 (3) supplemental fentanyl for anxiolysis.
- Delirium will be screened by trained physicians, registered nurses every 8 hours postoperatively with validated Thai-version CAM-ICU (Confusion Assessment Method-Intensive Care Unit) until patient discharge.
- Serum Interleukins (IL-1, IL-6) Tumor necrosis factor-Alpha and S100B protein from preoperative period will be compared with serum from postoperative period between delirium and non-delirium group. The level of serum biomarkers will be acquired in a 6-hour interval for 5 measurement points during the first postoperative day in the first 12 participants. The subsequent participants will have 1 measurement of serum biomarker during the first postoperative day.
- Genetic profile for ApolipoproteinE genotype will be acquired and compared between delirium and non-delirium group.
- Conditions
- Postoperative Delirium
- Being tested
- Propofol, Dexmedetomidine, Fentanyl
- Keywords
- postoperative delirium, total knee arthroplasty, propofol, dexmedetomidine, fentanyl, inflammatory response, interleukins, CAM-ICU
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
target-controlled infusion starting for Cet 0.1 mcg/ml to achieve MOAA/S 3-4
DexmedetomidineDrug
Incremental titration of dexmedetomidine starting from 0.1 mcg/kg/hr to achieve MOAA/S 3-4
FentanylDrug
0.25 mcg fo Fentanyl for anxiolysis
| Study group | Role | What they receive |
|---|---|---|
| Propofol-fentanyl | Experimental | Fentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring Receives: Drug: Propofol; Drug: Fentanyl |
| Dexmedetomidine | Experimental | Fentanyl 0.5 mcg/kg Dexmedetomidine in incremental titrated dose for moderate sedation to achieve MOAA/S 3-4 as end-point of titration Bispectral index (BIS) monitoring Receives: Drug: Dexmedetomidine; Drug: Fentanyl |
| Fentanyl | Experimental | Fentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium
Measured: Up to 7 days
Secondary outcomes (21)
The effect of age on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between age 65-75, 75-85, and >85 years of age
Measured: Up to 7 days
Apolipoprotein genotype
ApoE epsilon subtype analysis
Measured: 1 days
The effect of Apolipoprotein genotype on the incidence of postoperative delirium
ApoE epsilon subtype analysis
Measured: Up to 7 days
Inflammatory biomarker
Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein)
Measured: 2 days
The effect of delirium on inflammatory biomarker levels
Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein) comparison between delirium and non-delirium group
Measured: Up to 7 days
The effect of gender on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between male and female
Measured: Up to 7 days
The effect of ASA-physical status on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between ASA-PS I-II and III-IV
Measured: Up to 7 days
The effect of alcohol consumption on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between amount of alcohol consumption (standard drink/day)
Measured: Up to 7 days
The effect of cognitive inpairment on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without cognitive impairment. TMSE score will be use to determine cognitive status
Measured: Up to 7 days
The effect of coronary artery disease on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without coronary artery disease. Preoperative diagnosis of coronary artery disease will be used.
Measured: Up to 7 days
The effect of cerebrovascular disease on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without cerebrovascular disease. Preoperative diagnosis of cerebrovascular disease will be used.
Measured: Up to 7 days
The effect of chronic kidney disease on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without chronic kidney disease. Preoperative diagnosis of cerebrovascular disease will be used.
Measured: Up to 7 days
The effect of liver disease on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without liver disease. Preoperative diagnosis of liver disease will be used.
Measured: Up to 7 days
The effect of hypertension on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without hypertension. Preoperative diagnosis of hypertension will be used.
Measured: Up to 7 days
The effect of diabetes mellitus on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without diabetes mellitus. Preoperative diagnosis of diabetes will be used.
Measured: Up to 7 days
The effect of postoperative pain on the incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with mild (pain score 0-3), moderate (4-7) and severe (7-10). Numeric rating scale will be used.
Measured: Up to 7 days
The effect of intraoperative BIS value on the incidence of postoperative delirium
Intraoperative BIS value comparison between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium
Measured: 7 days
The effect of intraoperative blood transfusion and blood loss on the incidence of postoperative delirium
Intraoperative blood transfusion and blood loss will be compared between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium
Measured: 7 days
The effect of delirium on hospital length of stay
The hospital length of stay will be compared between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium
Measured: 7 days
The effect of delirium on postoperative rehabilitation
The time to assisted walking in the postoperative period will be compared between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium
Measured: 7 days
The effect of delirium on postoperative complications.
The incidence of 1) DVT 2) myocardial ischemia/infarction 3) urinary tract infection 4) stroke 5) wound infection will be compared between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start14 Jun 2017
- Primary completionMay 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, patcharee sriswasdi, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120442
- Sponsor's protocol ID
- 051/2560(EC2)
- Status last verified
- Sep 2021
- First submitted
- 15 Apr 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of Delirium and Other Major Complications on Outcomes After Elective Surgery in Older Adults. JAMA Surg. 2015 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606.
PubMed 26352694da Silva RR, Santos AA, de Sampaio Carvalho Junior J, Matos MA. Quality of life after total knee arthroplasty: systematic review. Rev Bras Ortop. 2014 Sep 19;49(5):520-7. doi: 10.1016/j.rboe.2014.09.007. eCollection 2014 Sep-Oct.
PubMed 26229855Rade MC, Yadeau JT, Ford C, Reid MC. Postoperative delirium in elderly patients after elective hip or knee arthroplasty performed under regional anesthesia. HSS J. 2011 Jul;7(2):151-6. doi: 10.1007/s11420-011-9195-2. Epub 2011 Feb 11.
PubMed 22754416Kinjo S, Lim E, Sands LP, Bozic KJ, Leung JM. Does using a femoral nerve block for total knee replacement decrease postoperative delirium? BMC Anesthesiol. 2012 Mar 10;12:4. doi: 10.1186/1471-2253-12-4.
PubMed 22405052Yen TE, Allen JC, Rivelli SK, Patterson SC, Metcalf MR, Flink BJ, Mirrakhimov AE, Lagoo SA, Vail TP, Young CC, Moon RE, Trzepacz PT, Kwatra MM. Association between Serum IGF-I levels and Postoperative Delirium in Elderly Subjects Undergoing Elective Knee Arthroplasty. Sci Rep. 2016 Feb 5;6:20736. doi: 10.1038/srep20736.
PubMed 26846868Liang CK, Chu CL, Chou MY, Lin YT, Lu T, Hsu CJ, Chen LK. Interrelationship of postoperative delirium and cognitive impairment and their impact on the functional status in older patients undergoing orthopaedic surgery: a prospective cohort study. PLoS One. 2014 Nov 17;9(11):e110339. doi: 10.1371/journal.pone.0110339. eCollection 2014.
PubMed 25402484Liang CK, Chu CL, Chou MY, Lin YT, Lu T, Hsu CJ, Lam HC, Chen LK. Developing a Prediction Model for Post-Operative Delirium and Long-Term Outcomes Among Older Patients Receiving Elective Orthopedic Surgery: A Prospective Cohort Study in Taiwan. Rejuvenation Res. 2015 Aug;18(4):347-55. doi: 10.1089/rej.2014.1645.
PubMed 25768947Nandi S, Harvey WF, Saillant J, Kazakin A, Talmo C, Bono J. Pharmacologic risk factors for post-operative delirium in total joint arthroplasty patients: a case-control study. J Arthroplasty. 2014 Feb;29(2):268-71. doi: 10.1016/j.arth.2013.06.004. Epub 2013 Jul 5.
PubMed 23831083Scott JE, Mathias JL, Kneebone AC. Incidence of delirium following total joint replacement in older adults: a meta-analysis. Gen Hosp Psychiatry. 2015 May-Jun;37(3):223-9. doi: 10.1016/j.genhosppsych.2015.02.004. Epub 2015 Feb 23.
PubMed 25774049Vasunilashorn SM, Ngo L, Inouye SK, Libermann TA, Jones RN, Alsop DC, Guess J, Jastrzebski S, McElhaney JE, Kuchel GA, Marcantonio ER. Cytokines and Postoperative Delirium in Older Patients Undergoing Major Elective Surgery. J Gerontol A Biol Sci Med Sci. 2015 Oct;70(10):1289-95. doi: 10.1093/gerona/glv083. Epub 2015 Jul 27.
PubMed 26215633Fournier A, Krause R, Winterer G, Schneider R. Biomarkers of postoperative delirium and cognitive dysfunction. Front Aging Neurosci. 2015 Jun 9;7:112. doi: 10.3389/fnagi.2015.00112. eCollection 2015.
PubMed 26106326Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013.
PubMed 24236147Tomaszewski D. Biomarkers of Brain Damage and Postoperative Cognitive Disorders in Orthopedic Patients: An Update. Biomed Res Int. 2015;2015:402959. doi: 10.1155/2015/402959. Epub 2015 Aug 31.
PubMed 26417595Hirsch J, Vacas S, Terrando N, Yuan M, Sands LP, Kramer J, Bozic K, Maze MM, Leung JM. Perioperative cerebrospinal fluid and plasma inflammatory markers after orthopedic surgery. J Neuroinflammation. 2016 Aug 30;13(1):211. doi: 10.1186/s12974-016-0681-9.
PubMed 27577265Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
PubMed 23992774
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia: a Comparison Between Intraoperative Sedation With Fentanyl, Fentanyl-dexmedetomidine and Fentanyl-propofol
- ClinicalTrials.gov ID
- NCT03120442
- Acronym / sponsor ID
- 051/2560(EC2)
- Conditions
- Postoperative Delirium
- Keywords
- postoperative delirium, total knee arthroplasty, propofol, dexmedetomidine, fentanyl, inflammatory response, interleukins, CAM-ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 19 Apr 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.
Postoperative delirium after total knee replacement surgery has been related to significant morbidity and mortality among high risk patients. Anesthetic care might play a role in the development of postoperative delirium.
The purpose of this study is to compare the incidence of postoperative delirium between different intraoperative sedation regimen. Delirium assessment using standardized screening tools will be done every 8 hours after surgery.
Detailed description
- In this randomized controlled trial, the investigator will compare the incidence of postoperative delirium after total knee arthroplasty between 3 intraoperative sedation regimens including (1) propofol-fentanyl (2) dexmedetomidine -fentanyl (3) fentanyl alone
- Anesthesia techniques include spinal anesthesia and adductor canal block for postoperative analgesia. Sedation will be provide per group assignment.
- After performance of regional anesthesia, sedation protocols will be used as followed: (1) target-controlled infusion of Propofol to achieve MOAA/S of 3-4 (2) incremental titration of Dexmedetomidine to achieve MOAA/S of 3-4 (3) supplemental fentanyl for anxiolysis.
- Delirium will be screened by trained physicians, registered nurses every 8 hours postoperatively with validated Thai-version CAM-ICU (Confusion Assessment Method-Intensive Care Unit) until patient discharge.
- Serum Interleukins (IL-1, IL-6) Tumor necrosis factor-Alpha and S100B protein from preoperative period will be compared with serum from postoperative period between delirium and non-delirium group. The level of serum biomarkers will be acquired in a 6-hour interval for 5 measurement points during the first postoperative day in the first 12 participants. The subsequent participants will have 1 measurement of serum biomarker during the first postoperative day.
- Genetic profile for ApolipoproteinE genotype will be acquired and compared between delirium and non-delirium group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol-fentanyl | Experimental | Drug: Propofol, Drug: FentanylFentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring |
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: FentanylFentanyl 0.5 mcg/kg Dexmedetomidine in incremental titrated dose for moderate sedation to achieve MOAA/S 3-4 as end-point of titration Bispectral index (BIS) monitoring |
| Fentanyl | Experimental | Drug: FentanylFentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 year or older
- Scheduled for elective primary total knee arthroplasty
Key exclusion criteria (7 listed)
- Contraindication for spinal anesthesia
- Contraindication for adductor canal block
- Allergy to fentanyl or propofol or dexmedetomidine or bupivacaine
- Cognitive impairment
- NSQIP database risk calculator > 10% overall complication
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 |
|---|---|---|
| Propofoltarget-controlled infusion starting for Cet 0.1 mcg/ml to achieve MOAA/S 3-4 | Drug | Propofol-fentanyl |
| DexmedetomidineIncremental titration of dexmedetomidine starting from 0.1 mcg/kg/hr to achieve MOAA/S 3-4 | Drug | Dexmedetomidine |
| Fentanyl0.25 mcg fo Fentanyl for anxiolysis | Drug | Dexmedetomidine, Fentanyl, Propofol-fentanyl |
Primary outcome
Incidence of postoperative delirium
Time frame: Up to 7 days
Positive CAM-ICU result and confirmed DSM-V criteria for delirium
21 secondary outcomes
The effect of age on the incidence of postoperative delirium
Time frame: Up to 7 days
Apolipoprotein genotype
Time frame: 1 days
The effect of Apolipoprotein genotype on the incidence of postoperative delirium
Time frame: Up to 7 days
Inflammatory biomarker
Time frame: 2 days
The effect of delirium on inflammatory biomarker levels
Time frame: Up to 7 days
The effect of gender on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of ASA-physical status on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of alcohol consumption on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of cognitive inpairment on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of coronary artery disease on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of cerebrovascular disease on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of chronic kidney disease on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of liver disease on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of hypertension on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of diabetes mellitus on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of postoperative pain on the incidence of postoperative delirium
Time frame: Up to 7 days
The effect of intraoperative BIS value on the incidence of postoperative delirium
Time frame: 7 days
The effect of intraoperative blood transfusion and blood loss on the incidence of postoperative delirium
Time frame: 7 days
The effect of delirium on hospital length of stay
Time frame: 7 days
The effect of delirium on postoperative rehabilitation
Time frame: 7 days
The effect of delirium on postoperative complications.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Background: PubMed 26352694Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of Delirium and Other Major Complications on Outcomes After Elective Surgery in Older Adults. JAMA Surg. 2015 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606.
- Background: PubMed 26229855da Silva RR, Santos AA, de Sampaio Carvalho Junior J, Matos MA. Quality of life after total knee arthroplasty: systematic review. Rev Bras Ortop. 2014 Sep 19;49(5):520-7. doi: 10.1016/j.rboe.2014.09.007. eCollection 2014 Sep-Oct.
- Background: PubMed 22754416Rade MC, Yadeau JT, Ford C, Reid MC. Postoperative delirium in elderly patients after elective hip or knee arthroplasty performed under regional anesthesia. HSS J. 2011 Jul;7(2):151-6. doi: 10.1007/s11420-011-9195-2. Epub 2011 Feb 11.
- Background: PubMed 22405052Kinjo S, Lim E, Sands LP, Bozic KJ, Leung JM. Does using a femoral nerve block for total knee replacement decrease postoperative delirium? BMC Anesthesiol. 2012 Mar 10;12:4. doi: 10.1186/1471-2253-12-4.
- Background: PubMed 26846868Yen TE, Allen JC, Rivelli SK, Patterson SC, Metcalf MR, Flink BJ, Mirrakhimov AE, Lagoo SA, Vail TP, Young CC, Moon RE, Trzepacz PT, Kwatra MM. Association between Serum IGF-I levels and Postoperative Delirium in Elderly Subjects Undergoing Elective Knee Arthroplasty. Sci Rep. 2016 Feb 5;6:20736. doi: 10.1038/srep20736.
- Background: PubMed 25402484Liang CK, Chu CL, Chou MY, Lin YT, Lu T, Hsu CJ, Chen LK. Interrelationship of postoperative delirium and cognitive impairment and their impact on the functional status in older patients undergoing orthopaedic surgery: a prospective cohort study. PLoS One. 2014 Nov 17;9(11):e110339. doi: 10.1371/journal.pone.0110339. eCollection 2014.
- Background: PubMed 25768947Liang CK, Chu CL, Chou MY, Lin YT, Lu T, Hsu CJ, Lam HC, Chen LK. Developing a Prediction Model for Post-Operative Delirium and Long-Term Outcomes Among Older Patients Receiving Elective Orthopedic Surgery: A Prospective Cohort Study in Taiwan. Rejuvenation Res. 2015 Aug;18(4):347-55. doi: 10.1089/rej.2014.1645.
- Background: PubMed 23831083Nandi S, Harvey WF, Saillant J, Kazakin A, Talmo C, Bono J. Pharmacologic risk factors for post-operative delirium in total joint arthroplasty patients: a case-control study. J Arthroplasty. 2014 Feb;29(2):268-71. doi: 10.1016/j.arth.2013.06.004. Epub 2013 Jul 5.
- Background: PubMed 25774049Scott JE, Mathias JL, Kneebone AC. Incidence of delirium following total joint replacement in older adults: a meta-analysis. Gen Hosp Psychiatry. 2015 May-Jun;37(3):223-9. doi: 10.1016/j.genhosppsych.2015.02.004. Epub 2015 Feb 23.
- Background: PubMed 26215633Vasunilashorn SM, Ngo L, Inouye SK, Libermann TA, Jones RN, Alsop DC, Guess J, Jastrzebski S, McElhaney JE, Kuchel GA, Marcantonio ER. Cytokines and Postoperative Delirium in Older Patients Undergoing Major Elective Surgery. J Gerontol A Biol Sci Med Sci. 2015 Oct;70(10):1289-95. doi: 10.1093/gerona/glv083. Epub 2015 Jul 27.
- Background: PubMed 26106326Fournier A, Krause R, Winterer G, Schneider R. Biomarkers of postoperative delirium and cognitive dysfunction. Front Aging Neurosci. 2015 Jun 9;7:112. doi: 10.3389/fnagi.2015.00112. eCollection 2015.
- Background: PubMed 24236147Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013.
- Individual participant dataSharing planned: Undecided
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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 Propofol, Dexmedetomidine and Fentanyl in people with Postoperative Delirium, run by Mahidol University at 1 site in Thailand.
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 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2021. 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 Thailand. 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?
Results are not available in the source record.
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 postoperative delirium (time frame: Up to 7 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 NCT03120442, which also lists 32 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 21 Sep 2021.