How Different Sedatives Affect Hip Fracture Patient's Postoperative Delirium

NCT03346226 | Unknown Phase 4

• 1 other identifier: Postoperative Delirium
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Delirium in Old Age

Keywords

Delirium Dexmedetomidine elderly

Outcome Measures

Primary Outcomes (1)

• occurrence of postoperative delirium in postoperative 72 hours

  Evaluation of delirium is performed by trained investigational assistant who does not know the randomization of patients. Follow up is carried out before operation and at 9Am and 3Pm during post-operative day 1-3 (POD1-3). During follow up, RASS (Richmond Agitation-Sedation Scale, RASS) is used firstly to evaluate sedation of the patients, and for those with ARSS \>-4 (-3～+4), the Confusion Assessment Method (CAM) is adopted for evaluation. A case consistent with delirium standard at any time point during follow up is determined to be delirium positive. Diagnosis should be confirmed for a CAM-positive patient by a psychological expert based on DSM-V standard

  patient enrolled will be evaluated at 9Am and 3Pm during post-operative day 1-3 (POD1-3).At any time point above，delirium is detected，then the patient will be diagnosed as postoperative delirium. All patients enrolled is Non-delirium before surgery。

Secondary Outcomes (7)

• Consumption of analgesic

  record the data of comsumption of analgeisic at 48 hours after operation

• Times of intra-operative occurrence of hypotension, bradycardia, hypertension and tachycardia that need treatment.

  during the operation

• Score of quality of post-operative sleeping

  quality of sleeping will be assessed at 9Am during post-operative day 1-3

• Hospital stay

  record the days of hospital stay at the 30 days after surgery

• Post-operative complications besides delirium

  observe and evaluate complications at the 30 days after surgery

Study Arms (2)

Dexmedetomidine Hydrochloride

EXPERIMENTAL

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.

Drug: Dexmedetomidine Hydrochloride

Propofol

ACTIVE COMPARATOR

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.

Drug: Propofol

Interventions

Dexmedetomidine Hydrochloride 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

Also known as: brand name ：YiSi

Dexmedetomidine Hydrochloride

Propofol 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

Also known as: Brand name：Diprivan or other brands of propofol

Propofol

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Acquisition of informed consent,
• Patients with hip fracture surgery under lumbar anesthesia,
• Grade II to III based on American Society of Anesthesiologists ASA classification,
• Age ≥65 and ≤90 years old.

You may not qualify if:

• History of psychiatric disease or a disease needing long-term exposure to psychotropic drugs (dementia, schizophrenia), or history of alcoholic abuse.
• More than 8 errors in preoperative Simplified Psychology and Mental Status Questionnaire (SPMSQ) , and diagnosed as severe cognitive impairment.
• CAM positive diagnosed preoperatively.
• Any cerebrovascular accident occurring within 3 months, such as cerebral stroke or transient ischemic attack (TIA).
• Systolic pressure \< 90mmHg and diastolic pressure \< 60mm Hg at the preoperative follow up or HR\< 50/minute.
• 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)
• 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.
• Diabetes patients with severe complications of diabetes (Diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular diseases, and diabetic nephropathy)
• Patients with severe infection.
• Postoperative PaO2\<60mmHg or SpO2\<92%.
• Participation in clinical trials of other drugs within past 30 days.
• Disturbed verbal communication, and unable to accomplish the test on cognition.
• Patients with prosthesis fracture or restoration; hip fracture but complicated with severe trauma in other sites.
• Being allergic to investigational drug or having contradiction of lumbar anesthesia.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• First Affiliated Hospital of Guangxi Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Qianfoshan Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator
• Tang-Du Hospital: collaborator
• Second Hospital of Shanxi Medical University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Shanghai Changzheng Hospital: collaborator
• The Fuzhou No 2 Hospital: collaborator
• Foshan Hospital of Traditional Chinese Medicine: collaborator
• Beijing Jishuitan Hospital: collaborator

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xue ZhangGang, doctor

  Anesthesiology Department of Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang XiaoGuang, Doctor

CONTACT

+86 13641995733; zhangxg@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the intervention is happend in the operation，the outcome assessment is going after the operation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Anesthesiology Department, Principal Investigator, Clinical Professor

Model Details: Dexmedetomidine group：dexmedetomidine is given to patients under spinal anesthesia until the end of surgery propofol group:Propofol is given to patients uunder spinal anesthesia until the end of surgery

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: June 30, 2019
• Last Updated: December 13, 2017

Record last verified: 2017-12