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

Tang-Du Hospital

Status and phase: Unknown; Phase 4

Conditions: Postoperative Confusion

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02134093

Tangdu sedation

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium

Drug: Normal saline

Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium

High dose group, dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium

Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium

Drug: Dexmedetomidine

Low dose group, dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium

Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium

Drug: Dexmedetomidine