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Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.

Dexmedetomidine vs Propofol Sedation Reduces Postoperative Delirium in Patients Receiving Hip Arthroplasty.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02793986
Enrollment
296
Registered
2016-06-08
Start date
2015-08-31
Completion date
2017-06-29
Last updated
2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local Anesthesia

Brief summary

With blocks of lumbar and lumbar plexus, we can reduce the intravenous anesthetics usage. To offer an satisfied surgery process for patients, a proper sedation is necessary. So in this study, we want to investigate the influence of two different sedative drugs on outcomes of patients received hip replacement surgery .

Interventions

DRUGpropofol

For patients in Group P, the sedation was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml.

DRUGdexmedetomidine

For patients in Group D, the sedation was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h. The depth of sedation was considered enough when patient was unresponsive to voice.

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 65 years or older and undergoing hip fracture repair

Exclusion criteria

* Patients with severe cognitive impairment (MMSE score, \<15) * Preoperative delirium as determined by Confusion Assessment Method * Contraindications to local anesthesia * Prior hip surgery * Mental or language barriers that would preclude data collection * Severe congestive heart failure (NewYork Heart Association class IV) * Severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV)

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative delirium7 days after surgery
Mortality in 30 days after surgery30 days after surgery

Secondary

MeasureTime frame
Out of bed time7 days after surgery
Discharge time30 days after surgery
Complications of cardiopulmonary system30 days after surgery
Extubation time7 days after surgery
Hemodynamic indexintraoperative
Dosage of vasoactive agentDuring sugary
Incidence of cerebrovascular accident30 days after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026