The timing and dose of dexmedetomidine on postoperative delirium

ISRCTN	ISRCTN85517037
DOI	https://doi.org/10.1186/ISRCTN85517037
Secondary identifying numbers	N/A

Submission date: 02/02/2018
Registration date: 06/02/2018
Last edited: 05/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Cheol Lee
Scientific

Wonkwang University Hospital
Muwang-ro 895
Iksan
54538
Korea, South

Phone	+82 63 859 1564
Email	ironyii@wku.ac.kr

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	No participant information sheet available
Scientific title	The effect of the timing and dose of dexmedetomidine on postoperative delirium in elderly patients after laparoscopic major non-cardiac surgery
Study objectives	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(s)	Institutional review board of Wonkwang University Hospital, 05/04/2016, ref: Registration No. 3001
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)	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 study start date	01/02/2016
Completion date	10/06/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	354
Key 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
Key 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
Date of first enrolment	01/05/2016
Date of final enrolment	30/05/2017

Locations

Countries of recruitment

Korea, South

Study participating centre

Wonkwang University Hospital

Muwang-ro 895
Iksan
54538
Korea, South

Sponsor information

Wonkwang University Hospital
Hospital/treatment centre

Muwang-ro 895
Iksan
54538
Korea, South

"ROR"	https://ror.org/0183m5185

Funders

Funder type

University/education

Wonkwang University
Private sector organisation / Universities (academic only)

Location: Korea, South

Results and Publications

Intention to publish date	30/07/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Plans to publish in the Journal of Clinical Anesthesia.
IPD sharing plan	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.