Condition category
Surgery
Date applied
02/02/2018
Date assigned
06/02/2018
Last edited
05/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Wonkwang University Hospital

Sponsor details

Muwang-ro 895
Iksan
54538
Korea
South

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes