Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- The incidence of postoperative delirium
Overview
Brief Summary
Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing selective craniotomy.
- •Age ≥65 years.
- •Obtain written informed consent.
Exclusion Criteria
- •Operation time less than 2 hours.
- •Refusal to provide written informed consent.
- •Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
- •Allergic to the study drug.
- •Body mass index ≤18 or ≥ 30 kg/m
- •History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
- •History of traumatic brain injury or neurosurgery.
- •Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
- •Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
- •The functional neurosurgery.
Arms & Interventions
Placebo group
The placebo group patients will be received 0.9% saline intraoperatively.
Intervention: 0.9% saline (Drug)
DEX group
The DEX group patients will be received dexmedetomidine intraoperatively.
Intervention: Dexmedetomidine (Drug)
Outcomes
Primary Outcomes
The incidence of postoperative delirium
Time Frame: postoperative 5 day
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable. Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present. In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.
Secondary Outcomes
- Pain severity score(postoperative 5 day)
- The quality of recovery(postoperative 1 day)
- The quality of sleep(postoperative 3 day)
- Cognitive function(1 day before surgery and 5 days after surgery)
- Psychological health state(1 day before surgery and postoperative 5 day)
- The intraoperative data(The surgery day)
- Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications.(postoperative 5 day)
- 30-day all-cause mortality(postoperative 30 day)
- The physiological status(1 day before surgery)
- Electroencephalogram changes(The surgery day)
- Regional cerebral oxygen saturation changes(The surgery day)
Investigators
Yuming Peng
Deputy chief of Department of Anesthesiology
Beijing Tiantan Hospital