Plain English Summary
Background and study aims
Delirium is a state of mental confusion that can occur after surgery. This is very common in elderly patients undergoing major surgery including cardiac surgery, and is a relatively frequent and serious complication. Previous studies have reported that sedation with the medication called dexmedetomidine (a medication that can reduce anxiety or used as a sedative) can be associated with a lower incidence, duration, and severity of postoperative delirium. The aim of this study is to examine three different types and timing of dexmedetomidine dosages on stress in older patients who are undergoing surgery.
Who can participate?
Adults aged 65 and older who are scheduled for a major non-cardiac surgery and will be undergoing general anesthesia.
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive dexmedetomidine from the start of anaesthesia to the end of the surgery. Those in the second group receive dexmedatomidine 15 minutes before the end of surgery. Those in the last group receive saline for 15 minutes before the end of surgery. Participants are assessed for their delirium for five days after surgery.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their symptoms. There are small risks of discomfort and bleeding when providing blood samples.
Where is the study run from?
Wonkwang University Hospital (South Korea)
When is the study starting and how long is it expected to run for?
February 2016 to June 2017
Who is funding the study?
Wonkwang University (South Korea)
Who is the main contact?
Professor Cheol Lee (Scientific)
ironyii@wku.ac.kr
Trial website
Contact information
Type
Scientific
Primary contact
Prof Cheol Lee
ORCID ID
Contact details
Wonkwang University Hospital
Muwang-ro 895
Iksan
54538
Korea
South
+82 63 859 1564
ironyii@wku.ac.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of the timing and dose of dexmedetomidine on postoperative delirium in elderly patients after laparoscopic major non-cardiac surgery
Acronym
Study hypothesis
Various dexmedetomidine dosage and timing regimens would vary the concentration of stress hormones and systemic inflammatory response to surgery. The changes in the concentrations of stress hormones and inflammatory mediators released in response to surgery would be affected the incidence and duration of postoperative delirium.
Ethics approval
Institutional review board of Wonkwang University Hospital, 05/04/2016, ref: Registration No. 3001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Patients >65 years of age undergoing laparoscopic major non-cardiac surgery under general anesthesia
Intervention
Participants are randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 3 treatment groups:
1. Group D1 receive dexmedetomidin in a 1 μg/kg bolus followed by 0.2 to 0.7 μg/kg/ h infusion from induction of anesthesia to the end of surgery
2. Group D2 receive dexmedetomidine in a 1 μg/kg diluted to a total volume of 10 mL in saline [0.9%] over a 10 min period) at 15 min before the end of surgery
3. Group S receive an equivalent volume of saline 15 minutes before the end of surgery.
Participants are blinded to the anesthetic agent; however, anesthesiologists and nurses are not because they needed to adjust the timing and dose of dexmedetomidine. The researchers who assess the outcomes are, however, blinded.
Participants are assessed for delirium for 5 days after surgery.
Intervention type
Drug
Phase
Drug names
Dexmedetomidine
Primary outcome measure
The incidence of delirium is mesaured using the confusion assessment method (CAM) for 5 days after surgery.
Secondary outcome measures
1. Duration of delirium is measured using the confusion assessment method (CAM) up to five days after surgery
2. Cortisol levels are measured using saliva samples at one and 24 hours after surgery
3. C-reactive protein (CRP), and cytokine (tumor necrosis factor [TNF]-alpha, interleukin [IL]-1β, IL-2, IL-6, IL-8, and IL-10) levels measured using blood samples at one and 24 hours after surgery
Overall trial start date
01/02/2016
Overall trial end date
10/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients > 65 years of age
2. Classified as class I or III according to the American Society of Anesthesiologists (ASA)
3. Scheduled for laparoscopic major non-cardiac surgery under general anesthesia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
354
Participant exclusion criteria
1. Patients with a history of kidney or liver disease
2. History of allergy to the drug being studied
3. Cognitive impairment
4. Use of antipsychotic alpha-2 agonists or antagonist medications
5. Use of anti-inflammatory drugs
Recruitment start date
01/05/2016
Recruitment end date
30/05/2017
Locations
Countries of recruitment
Korea, South
Trial participating centre
Wonkwang University Hospital
Muwang-ro 895
Iksan
54538
Korea, South
Funders
Funder type
University/education
Funder name
Wonkwang University
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Korea, South
Results and Publications
Publication and dissemination plan
Plans to publish in the Journal of Clinical Anesthesia.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at the Institutional Review Board for five years after finishing the study.
Intention to publish date
30/07/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list