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OpenTrials
Completed

NCT Number: NCT02793986

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

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 .

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Key information

Conditions

Anesthesia Local Anesthesia

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affiliated hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Propofol

Drug

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.

Dexmedetomidine

Drug

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.

Primary outcomes

  1. Incidence of postoperative delirium

    Time frame: 7 days after surgery

  2. Mortality in 30 days after surgery

    Time frame: 30 days after surgery

Secondary outcomes

  1. Complications of cardiopulmonary system

    Time frame: 30 days after surgery

  2. Incidence of cerebrovascular accident

    Time frame: 30 days after surgery

  3. Out of bed time

    Time frame: 7 days after surgery

  4. Discharge time

    Time frame: 30 days after surgery

  5. Dosage of vasoactive agent

    Time frame: During sugary

  6. Extubation time

    Time frame: 7 days after surgery

  7. Hemodynamic index

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2016
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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