The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery

Brain Injury Clinical Trial

Official title:

The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery,A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02123355
• Other study ID #: SPPHA01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 20, 2014
• Last updated: April 24, 2014
• Start date: August 2014
• Est. completion date: August 2014

Study information

• Verified date: April 2014
• Source: Shaanxi Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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; -

Study Design

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

Related Conditions & MeSH terms

• Brain Injury
• Cognitive Ability, General

Intervention

Drug:
• Induction of anesthesia
Midazolam 0.05 mg/kg?Propofol 1.0 mg/kg?Sufentanyl 3µg/kg?Victracurium 0.1 mg/kg sequential intravenous injection

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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shaanxi Provincial People's Hospital	Chinese Medical Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in cognitive function at 7 days	Modified Newman scale to assess the cognitive function, including five tests.; The quiet environment, enough daylight, no disturb is needed when the modified Newman scale is done. All the five tests are finished within 30 min.; all the score of each test of all the patients assessed before the surgery is calculated, then get the standard variation, the score of each subject of each test is compared with the standard deviation, if one or more stand deviation decrease, then the cognitive function is considered as deterioration .; When 2 or more of the tests is considered as deterioration, then the patients is diagnosed as Post Operation Cognitive Dysfunction (POCD).	Baseline, the 7th day after the surgery	Yes
Secondary	Brain injury assessment	2 ml blood sample is collected at 8 time points including before surgery,the right moment,2 hr and 4 hr after the induction, the right moment,12,24 and 48 hours after the surgery.; The serum level of C-reaction protein(CRP),tumor necrosis factor(TNF-a)?interleukin-6(IL-6),interleukin-10(IL-10) is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA)	From entering the operating room to 48 hours after the surgery	Yes
Secondary	Inflammatory responsive assessment	2 ml blood sample is collected at 8 time points including before surgery,the right moment,2 hr and 4 hr after the induction, the right moment,12,24 and 48 hours after the surgery.; The concentration of protein S100B(S100B)and neuron specific enolase (NSE)in serum is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA).	From entering the operating room to 48 hours after the surgery	Yes
Secondary	Heart rate	Heart rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.	From the induction of anesthesia to the right moment of extubation, up to 1 day.	Yes
Secondary	Depth of anesthesia	Bispectral index(BIS) monitor are performed every 15 min from the induction of anesthesia to the right moment of extubation.	From the induction of anesthesia to the right moment of extubation, up to 1 day.	No
Secondary	Recovery of anesthesia	Time of anesthetic ceased,time of call to open eyes,time to extubation, time to leave the PACU are recorded.	From the induction of anesthesia to the right moment of extubation, up to 1 day.	Yes
Secondary	Central venous pressure(CVP)	Central venous pressure(CVP) are monitored every 15 min from the induction of anesthesia to the right moment of extubation.	From the induction of anesthesia to the right moment of extubation, up to 1 day.	Yes
Secondary	Blood pressure	systolic blood pressure, Diastolic blood pressure are monitored every 15 min from the induction of anesthesia to the right moment of extubation.	From the induction of anesthesia to the right moment of extubation, up to 1 day.	Yes
Secondary	Respiration rate	Respiration rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.	From the induction of anesthesia to the right moment of extubation, up to 1 day.	Yes
Secondary	Pulse blood oxygen saturation	Pulse blood oxygen saturation are monitored every 15 min from the induction of anesthesia to the right moment of extubation.	From the induction of anesthesia to the right moment of extubation, up to 1 day.	Yes
Secondary	Number of Participants with Serious and Non-Serious Adverse Events		Up to 7 days	Yes