How Different Sedatives Affect Hip Fracture Patient's Postoperative Delirium

NCT ID: NCT03346226

Last Updated: 2017-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-06-30

Brief 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

Detailed 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

Conditions

Delirium in Old Age

Keywords

Delirium Dexmedetomidine elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dexmedetomidine Hydrochloride

Dex Group: 0.5 μg/kg of Dex is given 10 minutes before operation through injection pump during 15 minutes. After the operation starts, the initial pumping ratio of Dex is 0.5ug/kg/h and adjusted under BIS surveillance to keep BIS between 70-80 until 30 minutes before the end of surgery. Meanwhile, OAA/S grade is evaluated every 15 minutes to maintain OAA/S at grade 4. If discrepancy occurs, OAA/S prevails.

Group Type: EXPERIMENTAL

Dexmedetomidine Hydrochloride

Intervention Type: DRUG

Dexmedetomidine is given to patients during spinal anesthesia at the dose of 0.5 μg/kg，adjusted the dose to keep BIS between 70-80 until 30 minutes before the end of surgery

Propofol

Prop Group: Propofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts. Under BIS surveillance, dripping rate is adjusted to keep BIS between 70-80 until 5 minutes before the end of surgery. Meanwhile, OAA/S grade is evaluated every 15 minutes to maintain OAA/S at grade 4. If discrepancy occurs, OAA/S prevails.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts，adjust the propofol's dose to keep BIS between 70-80 before the end of surgery

Interventions

Dexmedetomidine Hydrochloride

Dexmedetomidine is given to patients during spinal anesthesia at the dose of 0.5 μg/kg，adjusted the dose to keep BIS between 70-80 until 30 minutes before the end of surgery

Intervention Type: DRUG

Propofol

Propofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts，adjust the propofol's dose to keep BIS between 70-80 before the end of surgery

Intervention Type: DRUG

Other Intervention Names

brand name ：YiSi; Brand name：Diprivan or other brands of propofol

Eligibility Criteria

Inclusion Criteria

1. Acquisition of informed consent,

2. Patients with hip fracture surgery under lumbar anesthesia,

3. Grade II to III based on American Society of Anesthesiologists ASA classification,

4. Age ≥65 and ≤90 years old.

Exclusion Criteria

1. History of psychiatric disease or a disease needing long-term exposure to psychotropic drugs (dementia, schizophrenia), or history of alcoholic abuse.

2. More than 8 errors in preoperative Simplified Psychology and Mental Status Questionnaire (SPMSQ) , and diagnosed as severe cognitive impairment.

3. CAM positive diagnosed preoperatively.

4. Any cerebrovascular accident occurring within 3 months, such as cerebral stroke or transient ischemic attack (TIA).

5. Systolic pressure < 90mmHg and diastolic pressure < 60mm Hg at the preoperative follow up or HR< 50/minute.

6. History of heat failure or EF<30% as shown by ultrasound cardiogram; degree 2 type 2 and degree 3 atrioventricular block. History of active heart disease (such as acute cardiac infarction, unstable angina pectoris)

7. Severe abnormality in hepatic or renal function (severe abnormality in liver function: more than 2-times increase than upper normal limit in any one of the markers including ALT,, conjugated bilirubin, AST, ALP, total bilirubin; severe abnormality in renal function; Cr clearance<30ml/min), Scr>443μmol/L.

8. Diabetes patients with severe complications of diabetes (Diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular diseases, and diabetic nephropathy)

9. Patients with severe infection.

10. Postoperative PaO2<60mmHg or SpO2<92%.

11. Participation in clinical trials of other drugs within past 30 days.

12. Disturbed verbal communication, and unable to accomplish the test on cognition.

13. Patients with prosthesis fracture or restoration; hip fracture but complicated with severe trauma in other sites.

14. Being allergic to investigational drug or having contradiction of lumbar anesthesia.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role: collaborator

Tang-Du Hospital

OTHER

Sponsor Role: collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: collaborator

The Fuzhou No 2 Hospital

OTHER

Sponsor Role: collaborator

Foshan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Beijing Jishuitan Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guowei Tu

director of Anesthesiology Department, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xue ZhangGang, doctor

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology Department of Shanghai Zhongshan Hospital

Central Contacts

Zhang XiaoGuang, Doctor

Role: CONTACT

Phone: +86 13641995733

Email: zhangxg@fudan.edu.cn

Other Identifiers

Postoperative Delirium

Identifier Type: -

Identifier Source: org_study_id