The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery

NCT ID: NCT02123355

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-08-31

Brief Summary

The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and POCD is also correlated with many other factors such as type of surgery, the duration of anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in geriatrics is important.

Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the prolonged surgery.

The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive function at prolonged surgery in geriatrics in geriatrics.

Conditions

Cognitive Ability, General; Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexmedetomidine

Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.

Group Type: EXPERIMENTAL

Induction of anesthesia

Intervention Type: DRUG

Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection

Intubation

Intervention Type: PROCEDURE

After muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35\~40 mmHg，pulse oxygen saturation is more than 95%.

Sevoflurane, remifentanil ,vecuronium

Intervention Type: DRUG

Sevoflurane（1%-2%）is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently.

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.

Normal saline

Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.

Group Type: SHAM_COMPARATOR

Induction of anesthesia

Intervention Type: DRUG

Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection

Intubation

Intervention Type: PROCEDURE

After muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35\~40 mmHg，pulse oxygen saturation is more than 95%.

Sevoflurane, remifentanil ,vecuronium

Intervention Type: DRUG

Sevoflurane（1%-2%）is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently.

Placebo

Intervention Type: DRUG

Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.

Interventions

Induction of anesthesia

Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection

Intervention Type: DRUG

Intubation

After muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35\~40 mmHg，pulse oxygen saturation is more than 95%.

Intervention Type: PROCEDURE

Sevoflurane, remifentanil ,vecuronium

Sevoflurane（1%-2%）is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently.

Intervention Type: DRUG

Dexmedetomidine

Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.

Intervention Type: DRUG

Placebo

Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent

2. Scheduled for elective abdominal surgery

3. Age≥65 yrs

4. Weight is within the range of ±20% of standard weight [standard weight=Height(cm)-80)×70﹪ for male and(Height(cm)-70)×60﹪] for female

5. American society of anesthesia classification I~III

6. Expected time of surgery is more than 4 hours -

Exclusion Criteria

1. Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg；

2. Serious cardiac,liver,kidney,lung, endocrine disease or sepsis.

3. Allergy to trial drug or other contraindication；

4. Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation

5. History of mental illness and cerebral vascular disease

6. History of unstable angina or myocardial infarction

7. Education level<7 yrs

8. Factors existed that affect cognition assessment such as language, visual sense,auditory sense disorders.

9. Abuse of narcotic analgesia or suspected;

10. Neuromuscular diseases;

11. Mentally unstable or has a mental illness;

12. Pregnant or breast-feeding women;

13. Attended other trial past 30 days; -

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

Sponsors

Chinese Medical Association

NETWORK

Sponsor Role: collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang Li

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SPPHA01

Identifier Type: -

Identifier Source: org_study_id