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

Postoperative Confusion Clinical Trial

Official title:

Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients -a Single-center, Randomized ,Double-blinded and Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02134093
• Other study ID #: Tangdu sedation
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 29, 2014
• Last updated: July 9, 2014
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2014
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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 .

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Confusion

Intervention

Drug:
• Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium
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)
• Dexmedetomidine
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.
• Normal saline
Continuous pump infusion normal saline with identical volume of dexmedetomidine.
• Maintenance of anesthesia , propofol, remifentanil,vecuronium
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Postoperative anxiety	Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales	one day before operation, first day after operation	No
Secondary	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	No
Secondary	Bleeding volume		At the beginning of operation,at the end of operation,up to 24 hours	No
Secondary	Total volume of fluid		At the beginning of operation,at the end of operation,up to 24 hours	No
Secondary	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	No
Secondary	The total dose of anaesthetic drugs		At the beginning of surgery,at the end of surgery,up to 24 hours	No
Secondary	The total dose of analgesic drugs		During perioperative period,up to 7 days	No
Secondary	Blood pressure		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	No
Secondary	Oxygen saturation		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	No
Secondary	End-tidal carbon dioxide		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	No
Secondary	Operation duration		At the beginning of surgery,at the end of surgery,up to 24 hours	No