A comparison of sedative agents (propofol versus dexmedetomidine) in awake implantation of neuromodulative systems
| ISRCTN | ISRCTN46302353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46302353 |
| EudraCT/CTIS number | 2015-000964-33 |
| Secondary identifying numbers | NL52755.078.15 |
- Submission date
- 21/09/2015
- Registration date
- 03/12/2015
- Last edited
- 24/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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)
Contact information
Public
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
 ORCID ID |
0000-0002-8721-5949 |
|---|
Scientific
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Dexmedetomidine versus propofol in awake implantation of neuromodulative systems |
| Study acronym | DexMedPro |
| 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(s) | Medical Ethical Committee Erasmus Medical Center, 17/09/2015, ref: NL5275507815 |
| Condition | Chronic pain |
| Intervention | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2015 |
| Overall study end date | 20/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 72 |
| Participant inclusion criteria | 1. Aged between 18 and 65 years. 2. Indication for implantation of a neuromodulative system |
| 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 | 05/10/2015 |
| Recruitment end date | 05/10/2017 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rotterdam
3015 CE
Netherlands
Sponsor information
Hospital/treatment centre
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
| Website | www.erasmusmc.nl |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication of results in a peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr FFJA ter Bruggen (f.terbruggen@erasmusmc.nl) (SPSS dataset). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2019 | 16/01/2020 | Yes | No |
| Protocol file | version 3 | 14/08/2015 | 15/08/2022 | No | No |
Additional files
Editorial Notes
24/08/2022: IPD sharing statement added.
15/08/2022: Protocol file uploaded.
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.
