Clinical Trials Logo

Clinical Trial Summary

the hypothesis is that Dexmedetomidine seems to decrease incidence of post-operative delirium . one possible mechanism is that Dex have a minor influence on cognition, since it has no effect on GABA receptor,another is that Dex could induce a sleep similar to natural sleep, thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative patients.

In this study , investigators devise the two different sedatives(Dexmedetomidine and Propofol)'influence on postoperative delirium in hip fracture elderly participants under spinal anesthesia


Clinical Trial Description

With a complex etiology, delirium is usually caused by various peri-operative stimuli on basis of predisposing factors, including senility, hypoxia and hypotension, pain, drug (such as pethidine, benzodiazepine, anticholinergic, and drug withdrawal), complications prior to surgery, post-operative sleep disorder. As for the mechanism of delirium, the commonly accepted hypothesis includes the decreased central cholinergic neurons function and the inflammation of central nervous system. Most of the hip fracture patients are senile, suffering generally from many complications with exposure to many drugs, and poor in nutritional status with decreased cognitive function even before the surgery in some of them, all of which are risk factors for post-operative delirium. Systematic review suggests that incidence of POD in patients undergoing elective hip arthroplasty is up to 4-53.3%. It is of great importance, therefore, to explore the effective approaches to lower POD incidence in senile patients with operation on hip fracture.

Dexmedetomidine Hydrochloride is a novel highly-selective α2 adrenergic receptor agonist, and its selectivity to α2 receptor is 8 times of that of clonidine. It has multiple functions including sedation, anti-anxiety, hypnosis, analgesia and sympathetic blockade, with a wide application prospect for peri-operative patients. Researches suggest that Dex applied peri-operatively may stabilize blood pressure and heart rate, control intra-operative stress, and decrease post-operative side reactions such as nausea, vomiting, restlessness, delirium and chills. Moreover, advantages of Dex also include analgesia and reduction of opioid usage. Clinical pharmacological characteristics of Dex suggest its possible function to decrease post-operative delirium. Meanwhile, Dex seems to have a minor influence on cognition, since it has no effect on GABA receptor.

Another important feature of it is that Dex induces a sleep similar to natural sleep, thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative patients, and decreasing incidence of post-operative delirium. Researches evaluating the capability of Dex to decrease delirium incidence are focused on ICU sedation post to operation. Riker et al compared the sedative effect between Dex and midazolam in patients with severe mechanical ventilation, revealing a lower delirium incidence in Dex than in midazolam (54.0% vs 76.6%) in patients maintained with the same depth of sedation. Systematic review concludes that Dex in effective to prevent and treat post-operative delirium in ICU patients.

In this study ,the investigators devise the two different sedatives (Dexmedetomidine and Propofol)'influence on postoperative delirium in hip fracture elderly participants under spinal anesthesia ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03346226
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact Zhang XiaoGuang, Doctor
Phone +86 13641995733
Email zhangxg@fudan.edu.cn
Status Not yet recruiting
Phase Phase 4
Start date January 1, 2018
Completion date June 30, 2019

See also
  Status Clinical Trial Phase
Completed NCT05690672 - Screening for Delirium in Older Inpatients N/A
Completed NCT04656379 - The Incidence and Risk Factors of Postoperative Delirium
Recruiting NCT04187807 - Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department N/A
Active, not recruiting NCT04654962 - Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the HUFSFB and HUSJI From 2019 - 2020
Completed NCT03485183 - The Effect of White and Pink Noise on Hospitalized Older Adults N/A
Recruiting NCT05815017 - YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility N/A
Recruiting NCT05694091 - Correlation of Perioperative Brain Metabolites With Postoperative Delirium in Elderly Oral Craniomaxillofacial Surgery Patients
Completed NCT06382961 - Postoperative Dexmedetomidine in Prevention of Postoperative Delirium N/A
Recruiting NCT06100029 - The Effect of Lavender Essential Oil for Delirium in Elderly Intensive Care Unit Patients: Study Protocol N/A
Not yet recruiting NCT06111300 - Dexmedetomidine Effect on Delirium of Elderly Patients Phase 4
Recruiting NCT05391334 - Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium
Completed NCT06168773 - Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly Phase 2/Phase 3
Recruiting NCT05280860 - Effect of Bilateral RSB on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery N/A
Recruiting NCT05857462 - The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture N/A
Recruiting NCT04404959 - Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture N/A
Not yet recruiting NCT05819723 - Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries N/A
Recruiting NCT04393272 - Digital Intelligent Assistant for Nursing Application
Recruiting NCT05158998 - Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery Phase 4
Not yet recruiting NCT06326372 - The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients
Completed NCT03175276 - Informant Questionaire on Cognitive Decline in the Elderly (IQCODE) and Delirium in Geriatric Patients