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The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery

Primary Purpose

Cognitive Ability, General, Brain Injury

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Induction of anesthesia

Intubation

Sevoflurane, remifentanil ,vecuronium

Dexmedetomidine

Placebo

About this trial

This is an interventional treatment trial for Cognitive Ability, General

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent
Scheduled for elective abdominal surgery
Age≥65 yrs
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
American society of anesthesia classification I~III
Expected time of surgery is more than 4 hours -

Exclusion Criteria:

Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg；
Serious cardiac,liver,kidney,lung, endocrine disease or sepsis.
Allergy to trial drug or other contraindication；
Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation
History of mental illness and cerebral vascular disease
History of unstable angina or myocardial infarction
Education level<7 yrs
Factors existed that affect cognition assessment such as language, visual sense,auditory sense disorders.
Abuse of narcotic analgesia or suspected;
Neuromuscular diseases;
Mentally unstable or has a mental illness;
Pregnant or breast-feeding women;
Attended other trial past 30 days; -

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dexmedetomidine

Normal saline

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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-α)、interleukin-6（IL-6）,interleukin-10（IL-10) is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA)

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).

Heart rate

Heart rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

Depth of anesthesia

Bispectral index(BIS) monitor are performed every 15 min from the induction of anesthesia to the right moment of extubation.

Recovery of anesthesia

Time of anesthetic ceased,time of call to open eyes,time to extubation, time to leave the PACU are recorded.

Central venous pressure(CVP)

Central venous pressure(CVP) are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

Blood pressure

systolic blood pressure, Diastolic blood pressure are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

Respiration rate

Respiration rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

Pulse blood oxygen saturation

Pulse blood oxygen saturation are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

Number of Participants with Serious and Non-Serious Adverse Events

Full Information

NCT ID

NCT02123355

First Posted

April 20, 2014

Last Updated

April 24, 2014

Sponsor

Shaanxi Provincial People's Hospital

Collaborators

Chinese Medical Association

1. Study Identification

Unique Protocol Identification Number

NCT02123355

Brief Title

The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 2014 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shaanxi Provincial People's Hospital

Collaborators

Chinese Medical Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Ability, General, Brain Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine

Arm Type

Experimental

Arm Description

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

Arm Title

Normal saline

Arm Type

Sham Comparator

Arm Description

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

Intervention Name(s)

Induction of anesthesia

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Intubation

Intervention Description

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

Drug

Intervention Name(s)

Sevoflurane, remifentanil ,vecuronium

Intervention Description

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

Intervention Name(s)

Dexmedetomidine

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in cognitive function at 7 days

Description

Time Frame

Baseline, the 7th day after the surgery

Secondary Outcome Measure Information:

Title

Brain injury assessment

Description

Time Frame

From entering the operating room to 48 hours after the surgery

Title

Inflammatory responsive assessment

Description

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).

Time Frame

From entering the operating room to 48 hours after the surgery

Title

Heart rate

Description

Heart rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.

Time Frame