Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients

NCT02134093 | Unknown Phase 4

• 1 other identifier: Tangdu sedation
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.

Conditions

Postoperative Confusion

Outcome Measures

Primary Outcomes (3)

• The change in memory

  The change in memory will be evaluated by Controlled Oral Word Association Test ,Semantic Fluency test

  one day before operation, first day after operation

• Cognitive function

  Cognitive function will be evaluated by Mini-mentalStateExamination,Digit-Symbol Substitution Test ,Trail Making Test

  one day before operation, first day after operation

• Postoperative anxiety

  Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales

  one day before operation, first day after operation

Secondary Outcomes (10)

• Heart rate

  At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room

• Bleeding volume

  At the beginning of operation,at the end of operation,up to 24 hours

• Total volume of fluid

  At the beginning of operation,at the end of operation,up to 24 hours

• Duration of one lung ventilation

  At the beginning of one lung ventilation,at the end of one lung ventilation,an expected average of 3 hours

• The total dose of anaesthetic drugs

  At the beginning of surgery,at the end of surgery,up to 24 hours

Study Arms (3)

Normal saline

PLACEBO COMPARATOR

Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery

Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Drug: Normal saline; Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium

High dose group, dexmedetomidine

EXPERIMENTAL

Continuous pump infusion dexmedetomidine at 1μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.4μg/kg/h until the end of surgery

Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Drug: Dexmedetomidine; Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium

Low dose group, dexmedetomidine

EXPERIMENTAL

Continuous pump infusion dexmedetomidine at 0.5μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.2μg/kg/h until the end of surgery

Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Drug: Dexmedetomidine; Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium

Interventions

Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium DRUG

Anesthesia induction:midazolam (0.03\~0.05 mg/kg), sufentanil(0. 5\~0.8 μg/kg), etomidate ( 0.2\~0.6mg/kg) and rocuronium(0.6mg/kg)

High dose group, dexmedetomidine; Low dose group, dexmedetomidine; Normal saline

Dexmedetomidine DRUG

Continuous pump infusion dexmedetomidine at 0.5μg/kg （low dose group）or 1μg/kg （high dose group）for 15 minutes before anesthesia induction，then followed by a continuous pump infusion at 0.2 μg/kg/h（low dose group）or 0.4μg/kg/h（high dose group） until the end of surgery.

High dose group, dexmedetomidine; Low dose group, dexmedetomidine

Normal saline DRUG

Continuous pump infusion normal saline with identical volume of dexmedetomidine.

Normal saline

Maintenance of anesthesia , propofol, remifentanil,vecuronium DRUG

Continuous infusion of propofol （3\~6 mg/kg/h）, remifentanil （0.05\~0.3 μg/kg/min）is required to maintain Entropy within 40\~60,Mean Arterial Blood Pressure more than 20% of baseline level , Oxygen Saturation more than 90% , airway pressure less than 40 cm H2O, intermittent injection vecuronium （0.05\~0.1mg/kg） as needed to maintain muscle relaxation.

High dose group, dexmedetomidine; Low dose group, dexmedetomidine; Normal saline

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Ongoing one-lung ventilation surgery.
• American Society of Anesthesiologists class I to III.
• Aged between 55 and 75 years old.
• Body Mass Index between 18 and 25 kg/m2.

You may not qualify if:

• Systolic blood pressure more than 180 mmHg or lower than 90 mmHg,diastolic blood pressure more than 110 mmHg or lower than 60 mmHg.
• Serious heart,liver,kidney, pulmonary, and endocrine disease or serious infection.
• Suspected or confirmed difficult airway.
• History of abnormal anesthesia.
• Suspected of malignant hyperthermia.
• Use of sedative and antidepressant drug or serious alcoholism
• Mini-mental State Examination less than 17.
• Highest academic degree below grade 6 in primary schools
• Patients inability to exchange with serious visual and hearing impairment or mental disability.
• History of shock.
• Carotid artery stenosis and central nervous system disease such as stroke, epilepsy.
• Allergic to investigational products or with other contraindication.
• Participated in other study within 30 days .

Sponsors & Collaborators

• Tang-Du Hospital: lead

MeSH Terms

Interventions

Rocuronium; Dexmedetomidine; Saline Solution; Propofol; Remifentanil; Vecuronium Bromide

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 8, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 11, 2014

Record last verified: 2014-07