Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Chronic (long-term) pain is any pain that has lasted for more than 12 weeks. It is estimated that as many as 20% of adults in Europe experience moderate to severe chronic pain in their lifetime. Often special exercises (physiotherapy) and medications can help ease chronic pain; however some people require more drastic measures. In some cases of severe chronic pain, implanting (placing inside of the body) a neuromodulation device may be recommended. Neuromodulation is a treatment where electrical signals are used to directly stimulate the nervous system (usually the spinal cord), by blocking pain signals. Although once the device is in place it can be very effective at relieving pain, the procedure itself is very painful and so patients are usually sedated. Propofol is a commonly used sedative, as it starts working and wears off very quickly. Propofol, however, can have harmful side effects, such as affecting the heart rate, blood pressure or respiratory system (breathing). It has been suggested that dexmedetomidine could be used as an alternative to propofol, as it is safer for the heart and respiratory system. This medication is often used in operations where the patient is awake, and so using it in neuromodulation implantation could help the patient feel more comfortable in the procedure. The aim of this study is to find out whether patients feel more comfortable and satisfied when dexmedetomidine is used compared to propofol.

Who can participate?
Adults who are suitable for a neuromodulation device implant.

What does the study involve?
Patients are randomly allocated into one of two groups. In the first group, patients are sedated using dexmedetomidine before the procedure. For the second group, patients are sedated using propofol before the procedure. Participants in both groups are given the pain relieving drug remifentanil throughout the procedure, and any negative effects of the medication are noted. Participants complete a questionnaire 24 hours after surgery to find out how well they thought the sedative used worked.

What are the possible benefits and risks of participating?
A potential benefit for participants in the dexmedetomidine group is that it may prove to be safer than propofol and so the risk of complications is lower. Risks of participating include the standard risks associated with surgery and sedation.

Where is the study run from?
Erasmus Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
February 2015 to December 2017

Who is funding the study?
Erasmus Medical Center (Netherlands)

Who is the main contact?
1. Miss Feline ter Bruggen (Public)
2. Professor Frank Huygen (Scientific)

Trial website

Contact information



Primary contact

Miss Feline ter Bruggen


Contact details

's-Gravendijkwal 230
3015 CE



Additional contact

Prof Frank Huygen


Contact details

's-Gravendijkwal 230
3015 CE

Additional identifiers

EudraCT number

2015-000964-33 number

Protocol/serial number


Study information

Scientific title

Dexmedetomidine versus propofol in awake implantation of neuromodulative systems



Study hypothesis

The objective of this study is to assess the overall patient satisfaction with the awake implantation of a neuromodulative system comparing dexmedetomidine with propofol (standard) as a sedative.

Ethics approval

Medical Ethical Committee Erasmus Medical Center, 17/09/2015, ref: NL5275507815

Study design

Single-centre randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Chronic pain


A randomisation list is provided by a statisticus. There are two treatment arms, one is the propofol arm and the other is the dexmedetomidine arm. The total duration of treatment is approximately 3 hours for the implantation of a neuromodulative system. The follow-up involves a patient satisfaction questionnaire, patient comfort score, measurement of hemodynamic data and respiration at 24 hours after surgery before the patient is going home.

Intervention type



Not Applicable

Drug names

1. Dexmedetomidine
2. Propofol

Primary outcome measure

Patient satisfaction during surgery, measured by using the Patient Sedation Satisfaction Index (PSSI) at 24 hours after surgery.

Secondary outcome measures

1. Hemodynamics (Mean arterial pressure, systolic blood pressure, diastolic blood pressure, heart rate) are measured before surgery, every 5 minutes during surgery and 24 hours after surgery
2. Respiration (SpO2) is measured by a peripheral saturation measurement before surgery, every 5 minutes during surgery and 24 hours after surgery
3. Sedation is measured using the Ramsey sedation score (RSS) before surgery, every 5 minutes during surgery and 24 hours after surgery
4. Pain is measured using the numeric rating score (NRS) before surgery, every 5 minutes during surgery and 24 hours after surgery
5. Complications are noted during and after surgery from medical observations
6. Cost-effectivity analysis measures the costs of medicine and patient satisfaction during surgery and 24 hours after surgery
7. Patients comfort and operators comfort is measured by using a comfort score 24 hours after surgery
8. The number of adjustments of dexmedetomidine or propofol titration is noted during surgery by using a count system

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Aged between 18 and 65 years.
2. Indication for implantation of a neuromodulative system

Participant type


Age group




Target number of participants


Total final enrolment


Participant exclusion criteria

1. Hypersensitivity of active part of one of any of the excipients
2. AV-blok (II or III)
3. Acute cerebrovascular disease
4. Pregnancy
5. Acute epilepsy
6. Severe liver dysfunction
7. Use of a beta blocker
8. Use of medications causing hypotension or bradycardia.
9. Psychologically unstable
10. Communication problem
11. Heart rate <60bpm
12. Allergy for soya or peanuts
13. Heart failure
14. Severe heart disease
15. Electroconvulsive therapy (ECT)
16. ASA III, IV, V

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Erasmus University Medical Center
's-Gravendijkwal 230
3015 CE

Sponsor information


Erasmus Medical Center

Sponsor details

's-Gravendijkwal 230
3015 CE

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Erasmus Medisch Centrum

Alternative name(s)

Erasmus Medical Center, Erasmus MC

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)



Results and Publications

Publication and dissemination plan

Publication of results in a peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2019 results in: (added 16/01/2020)

Publication citations

Additional files

Editorial Notes

16/01/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 09/04/2019: Internal review. 28/08/2018: IPD sharing statement added. 11/07/2018: The following changes were made to the trial record: 1. The overall trial end date was changed from 01/12/2017 to 20/04/2018. 2. The intention to publish date was changed from 31/12/2017 to 01/09/2018.