ElderlyPhase 4NCT03629483

Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block

A Phase 4 study testing Dexmedetomidine in people with Elderly and Knee Arthroplasty, run by Peking University First Hospital.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 65 to 90 years
Conditions the study is for: Elderly, Knee Arthroplasty, Nerve Block
What is being tested?: Dexmedetomidine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3 participants
Where: No sites listed yet
Study dates: 10 Dec 2018to 14 Dec 2018
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 65 to 90 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

Elderly patients (≥ 65 years but < 90 years);
Scheduled to undergo single total knee arthroplasty;
Planned to receive continuous femoral nerve block for postoperative analgesia.

Who cannot join

Refuse to participate in this study;
Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
Preoperative hemorrhagic disease or coagulopathy (platelet count, prothrombin time and/or activated partial thrombin time below the lower limit of normal);
Preoperative obstructive sleep apnea (diagnosed as obstructive sleep apnea, or STOP-Bang score ≥3);
Preoperative sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;

Show all 9Show fewer

Severe hepatic dysfunction (Child-Pugh class C);
Severe renal dysfunction (requirement of renal replacement therapy before surgery);
ASA classification ≥ IV or unlikely to survive for more than 24 hours after surgery.

About this study

Official title: Impact of Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block on Postoperative Delirium and Long-term Oucomes in Elderly Patients After Single Knee Arthroplasty

Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. Continuous femoral nerve block is frequently used for postoperative analgesia after total knee arthoplasty. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.

Read the detailed description

A growing number of elderly patients undergo total knee arthroplasty. Delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. Dexmedetomidine has been shown to prolong the duration of nerve block without neurotoxicity and improve postoperative sleep quality. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.

Conditions: Elderly, Knee Arthroplasty, Nerve Block, Dexmedetomidine, Postoperative Delirium, Long-term Outcome
Being tested: Dexmedetomidine, Placebo
Keywords: Elderly, Knee Arthroplasty, Nerve Block, Dexmedetomidine, Postoperative Delirium, Long-term Outcome
Medical subject headings: Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Continuous femoral nerve block with ropivacaine
Patients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h (equivalent to a dexmedetomidine infusion at a rate of 0.075 ug/kg/h).
PlaceboDrug
Also called Continuous femoral nerve block with ropivacaine
Patients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250 ml and placebo. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h.

Study groups in NCT03629483
Study group	Role	What they receive
Dexmedetomidine group	Experimental	For patients in the dexmedetomidine group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours (equivalent to dexmedetomidine infusion at a rate of 0.075 ug/kg/h). Receives: Drug: Dexmedetomidine
Control group	Placebo comparator	For patients in the control group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and placebo (normal saline). The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of delirium during the first 3 days after surgery
Incidence of delirium during the first 3 days after surgery
Measured: The first 3 days after surgery

Secondary outcomes (11)

Daily prevalence of delirium during postoperative days 1-3
Daily prevalence of delirium during postoperative days 1-3
Measured: The first 3 days after surgery
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Measured: Up to 30 days after surgery
Incidence of non-delirium complications within 30 days after surgery
Incidence of non-delirium complications within 30 days after surgery
Measured: Up to 30 days after surgery
All-cause 30-day mortality
All-cause 30-day mortality
Measured: At 30 days after surgery
Quality of life at 30 days after surgery
Quality of life at 30 days after surgery is assessed with the 12-items Short Form Health Survey (SF-12), a 12-item questionnaire that provides assessments of physical and mental health-related quality of life. The score ranges from 12 to 48, with higher score indicating better function.
Measured: At 30 days after surgery
Cognitive function at 30 days after surgery
Cognitive function at 30 days after surgery is assessed with modified Telephone Interview for Cognitive Status (TICS-m), a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 50, with higher score indicating better function.
Measured: At 30 days after surgery
Overall survival within 3 years after surgery
Overall survival within 3 years after surgery
Measured: Up to 3 years after surgery
Survival rates at the end of the 1st，2nd, and 3rd years after surgery
Survival rates at the end of the 1st，2nd, and 3rd years after surgery
Measured: At the end of the 1st, 2nd, and 3rd years after surgery
Incidence of new-onset diseases within 3 years after surgery
Incidence of new-onset diseases within 3 years after surgery
Measured: Up to 3 years after surgery
Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12
Quality of life at the end of the 1st, 2nd, and 3rd years after surgery is assessed with the 12-items Short Form Health Survey (SF-12), a 12-item questionnaire that provides assessments of physical and mental health-related quality of life. The score ranges from 12 to 48, with higher score indicating better function.
Measured: At the end of the 1st, 2nd, and 3rd years after surgery
Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery
Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery is assessed with modified Telephone Interview for Cognitive Status (TICS-m), a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 50, with higher score indicating better function.
Measured: At the end of the 1st, 2nd, and 3rd years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 201814 Dec 2018

First posted14 Aug 2018
Study start10 Dec 2018
Primary completion14 Dec 2018
Study completion14 Dec 2018

Why it stopped: The trial stopped by the sponsor because similar studies have been conducted.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for ElderlyStudies of the same condition, open and under way.
More trials run by Peking University First HospitalThe 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03629483
Sponsor's protocol ID: DEX 20180516
Status last verified: Jul 2025
First submitted: 8 Aug 2018
Last updated: 3 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mu DL, Zhang DZ, Wang DX, Wang G, Li CJ, Meng ZT, Li YW, Liu C, Li XY. Parecoxib Supplementation to Morphine Analgesia Decreases Incidence of Delirium in Elderly Patients After Hip or Knee Replacement Surgery: A Randomized Controlled Trial. Anesth Analg. 2017 Jun;124(6):1992-2000. doi: 10.1213/ANE.0000000000002095.
PubMed 28525512
Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66. doi: 10.1111/j.1532-5415.2005.53503.x.
PubMed 16181163
Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
PubMed 27542303
Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
PubMed 29742525
Wang XL, Wang J, Mu DL, Wang DX. [Dexmedetomidine combined with ropivacaine for continuous femoral nerve block improved postoperative sleep quality in elderly patients after total knee arthroplasty]. Zhonghua Yi Xue Za Zhi. 2018 Mar 13;98(10):728-732. doi: 10.3760/cma.j.issn.0376-2491.2018.10.003. Chinese.
PubMed 29562395
Choy WS, Lee SK, Kim KJ, Kam BS, Yang DS, Bae KW. Two continuous femoral nerve block strategies after TKA. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1901-8. doi: 10.1007/s00167-011-1510-4. Epub 2011 Apr 12.
PubMed 21484386
Duarte VM, Fallis WM, Slonowsky D, Kwarteng K, Yeung CK. Effectiveness of femoral nerve blockade for pain control after total knee arthroplasty. J Perianesth Nurs. 2006 Oct;21(5):311-6. doi: 10.1016/j.jopan.2006.05.011.
PubMed 17027440
Abdulatif M, Fawzy M, Nassar H, Hasanin A, Ollaek M, Mohamed H. The effects of perineural dexmedetomidine on the pharmacodynamic profile of femoral nerve block: a dose-finding randomised, controlled, double-blind study. Anaesthesia. 2016 Oct;71(10):1177-85. doi: 10.1111/anae.13603.
PubMed 27611039
Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9.
PubMed 21666435
Al-Metwalli RR, Mowafi HA, Ismail SA, Siddiqui AK, Al-Ghamdi AM, Shafi MA, El-Saleh AR. Effect of intra-articular dexmedetomidine on postoperative analgesia after arthroscopic knee surgery. Br J Anaesth. 2008 Sep;101(3):395-9. doi: 10.1093/bja/aen184. Epub 2008 Jun 20.
PubMed 18567675
Brummett CM, Norat MA, Palmisano JM, Lydic R. Perineural administration of dexmedetomidine in combination with bupivacaine enhances sensory and motor blockade in sciatic nerve block without inducing neurotoxicity in rat. Anesthesiology. 2008 Sep;109(3):502-11. doi: 10.1097/ALN.0b013e318182c26b.
PubMed 18719449
Behera BK, Puri GD, Ghai B. Patient-controlled epidural analgesia with fentanyl and bupivacaine provides better analgesia than intravenous morphine patient-controlled analgesia for early thoracotomy pain. J Postgrad Med. 2008 Apr-Jun;54(2):86-90. doi: 10.4103/0022-3859.40772.
PubMed 18480522
Halaszynski TM. Pain management in the elderly and cognitively impaired patient: the role of regional anesthesia and analgesia. Curr Opin Anaesthesiol. 2009 Oct;22(5):594-9. doi: 10.1097/ACO.0b013e32833020dc.
PubMed 19623056
Kosar CM, Tabloski PA, Travison TG, Jones RN, Schmitt EM, Puelle MR, Inloes JB, Saczynski JS, Marcantonio ER, Meagher D, Reid MC, Inouye SK. EFFECT OF PREOPERATIVE PAIN AND DEPRESSIVE SYMPTOMS ON THE DEVELOPMENT OF POSTOPERATIVE DELIRIUM. Lancet Psychiatry. 2014 Nov;1(6):431-436. doi: 10.1016/S2215-0366(14)00006-6.
PubMed 25642413
Siddiqi N, Harrison JK, Clegg A, Teale EA, Young J, Taylor J, Simpkins SA. Interventions for preventing delirium in hospitalised non-ICU patients. Cochrane Database Syst Rev. 2016 Mar 11;3(3):CD005563. doi: 10.1002/14651858.CD005563.pub3.
PubMed 26967259

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Elderly trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block on Postoperative Delirium and Long-term Oucomes in Elderly Patients After Single Knee Arthroplasty
ClinicalTrials.gov ID: NCT03629483
Acronym / sponsor ID: DEX 20180516
Conditions: Elderly, Knee Arthroplasty, Nerve Block, Dexmedetomidine, Postoperative Delirium, Long-term Outcome
Keywords: Elderly, Knee Arthroplasty, Nerve Block, Dexmedetomidine, Postoperative Delirium, Long-term Outcome
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial stopped by the sponsor because similar studies have been conducted.
Enrolment: 3 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Collaborators: Beijing Jishuitan Hospital
Study start: 10 Dec 2018 (actual)
Primary completion: 14 Dec 2018 (actual)
Study completion: 14 Dec 2018 (actual)
First posted: 14 Aug 2018 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dexmedetomidine group	Experimental	Drug: DexmedetomidineFor patients in the dexmedetomidine group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours (equivalent to dexmedetomidine infusion at a rate of 0.075 ug/kg/h).
Control group	Placebo comparator	Drug: PlaceboFor patients in the control group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and placebo (normal saline). The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours.

Who may qualify

Ages: 65 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Elderly patients (≥ 65 years but < 90 years);
Scheduled to undergo single total knee arthroplasty;
Planned to receive continuous femoral nerve block for postoperative analgesia.

Key exclusion criteria (9 listed)

Refuse to participate in this study;
Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
Preoperative hemorrhagic disease or coagulopathy (platelet count, prothrombin time and/or activated partial thrombin time below the lower limit of normal);
Preoperative obstructive sleep apnea (diagnosed as obstructive sleep apnea, or STOP-Bang score ≥3);

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: Continuous femoral nerve block with ropivacainePatients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h (equivalent to a dexmedetomidine infusion at a rate of 0.075 ug/kg/h).	Drug	Dexmedetomidine group
PlaceboAlso: Continuous femoral nerve block with ropivacainePatients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250 ml and placebo. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h.	Drug	Control group

Primary outcome

Incidence of delirium during the first 3 days after surgery
Time frame: The first 3 days after surgery
Incidence of delirium during the first 3 days after surgery

11 secondary outcomes

Daily prevalence of delirium during postoperative days 1-3
Time frame: The first 3 days after surgery
Length of stay in hospital after surgery
Time frame: Up to 30 days after surgery
Incidence of non-delirium complications within 30 days after surgery
Time frame: Up to 30 days after surgery
All-cause 30-day mortality
Time frame: At 30 days after surgery
Quality of life at 30 days after surgery
Time frame: At 30 days after surgery
Cognitive function at 30 days after surgery
Time frame: At 30 days after surgery
Overall survival within 3 years after surgery
Time frame: Up to 3 years after surgery
Survival rates at the end of the 1st，2nd, and 3rd years after surgery
Time frame: At the end of the 1st, 2nd, and 3rd years after surgery
Incidence of new-onset diseases within 3 years after surgery
Time frame: Up to 3 years after surgery
Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12
Time frame: At the end of the 1st, 2nd, and 3rd years after surgery
Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery
Time frame: At the end of the 1st, 2nd, and 3rd years after surgery

Results and safety

The study was stopped early (reason given: The trial stopped by the sponsor because similar studies have been conducted.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
Background: PubMed 28525512Mu DL, Zhang DZ, Wang DX, Wang G, Li CJ, Meng ZT, Li YW, Liu C, Li XY. Parecoxib Supplementation to Morphine Analgesia Decreases Incidence of Delirium in Elderly Patients After Hip or Knee Replacement Surgery: A Randomized Controlled Trial. Anesth Analg. 2017 Jun;124(6):1992-2000. doi: 10.1213/ANE.0000000000002095.
Background: PubMed 16181163Kalisvaart KJ, de Jonghe JF, Bogaards MJ, Vreeswijk R, Egberts TC, Burger BJ, Eikelenboom P, van Gool WA. Haloperidol prophylaxis for elderly hip-surgery patients at risk for delirium: a randomized placebo-controlled study. J Am Geriatr Soc. 2005 Oct;53(10):1658-66. doi: 10.1111/j.1532-5415.2005.53503.x.
Background: PubMed 27542303Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
Background: PubMed 29742525Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
Background: PubMed 29562395Wang XL, Wang J, Mu DL, Wang DX. [Dexmedetomidine combined with ropivacaine for continuous femoral nerve block improved postoperative sleep quality in elderly patients after total knee arthroplasty]. Zhonghua Yi Xue Za Zhi. 2018 Mar 13;98(10):728-732. doi: 10.3760/cma.j.issn.0376-2491.2018.10.003. Chinese.
Background: PubMed 21484386Choy WS, Lee SK, Kim KJ, Kam BS, Yang DS, Bae KW. Two continuous femoral nerve block strategies after TKA. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1901-8. doi: 10.1007/s00167-011-1510-4. Epub 2011 Apr 12.
Background: PubMed 17027440Duarte VM, Fallis WM, Slonowsky D, Kwarteng K, Yeung CK. Effectiveness of femoral nerve blockade for pain control after total knee arthroplasty. J Perianesth Nurs. 2006 Oct;21(5):311-6. doi: 10.1016/j.jopan.2006.05.011.
Background: PubMed 27611039Abdulatif M, Fawzy M, Nassar H, Hasanin A, Ollaek M, Mohamed H. The effects of perineural dexmedetomidine on the pharmacodynamic profile of femoral nerve block: a dose-finding randomised, controlled, double-blind study. Anaesthesia. 2016 Oct;71(10):1177-85. doi: 10.1111/anae.13603.
Background: PubMed 21666435Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9.
Background: PubMed 18567675Al-Metwalli RR, Mowafi HA, Ismail SA, Siddiqui AK, Al-Ghamdi AM, Shafi MA, El-Saleh AR. Effect of intra-articular dexmedetomidine on postoperative analgesia after arthroscopic knee surgery. Br J Anaesth. 2008 Sep;101(3):395-9. doi: 10.1093/bja/aen184. Epub 2008 Jun 20.
Background: PubMed 18719449Brummett CM, Norat MA, Palmisano JM, Lydic R. Perineural administration of dexmedetomidine in combination with bupivacaine enhances sensory and motor blockade in sciatic nerve block without inducing neurotoxicity in rat. Anesthesiology. 2008 Sep;109(3):502-11. doi: 10.1097/ALN.0b013e318182c26b.
Background: PubMed 18480522Behera BK, Puri GD, Ghai B. Patient-controlled epidural analgesia with fentanyl and bupivacaine provides better analgesia than intravenous morphine patient-controlled analgesia for early thoracotomy pain. J Postgrad Med. 2008 Apr-Jun;54(2):86-90. doi: 10.4103/0022-3859.40772.
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.

Dong-Xin Wang, MD, PhD principal investigator

Peking University First Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine in people with Elderly and Knee Arthroplasty, run by Peking University First Hospital.

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 9 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: stopped early, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

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 was stopped early (reason given: The trial stopped by the sponsor because similar studies have been conducted.). 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 delirium during the first 3 days after surgery (time frame: The first 3 days after surgery). 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 NCT03629483, which also lists 20 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 3 Aug 2025.