Delirium, Postoperative
Conditions
Keywords
Delirium, Dexmedetomidine, Adult Patients, Elective Major Surgery, General Anesthesia
Brief summary
Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.
Detailed description
After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery.
Interventions
DRUGPlacebo
Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
DRUGDexmedetomidine
Dexmedetomidine 0.1\ 0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ASA physical status class I-III * Aged 60 years or above * Elective major surgery under general anesthesia
Exclusion criteria
* ASA-PS\>=IV * Aged under 60 yr old * Body mass index (BMI) \>30 * Neurologic disease * Cardiac surgery and neurologic surgery * Anticonvulsant drugs * Chronic analgesics intake * Participating in the investigation of another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | every 8 hours within 24 postoperative hours | Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic parameters | every 5min during operation and every 15min during PACU stay | Heart frequency, systolic blood pressure, diastolic blood pressure |
| incidence of postoperative nausea and vomiting | 24 postoperative hours | incidence of postoperative nausea and vomiting |
| Length of PACU stay | during PACU stay | Length of PACU stay (min) |
| Postoperative delirium | 1st, 2nd, 3rd postoperative days | Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours |
| Postoperative Stroke | 1st, 2nd, 3rd, 7th postoperative days | Postoperative Stroke will be determined by National Institute of Health stroke scale (NIHSS score). |
| quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS) | 24 postoperative hours | quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS) |
Countries
China
Contacts
Primary ContactWei Mei, M.D.
Backup ContactYuke Tian, M.D.
Outcome results
None listed