A comparison of sedative agents (propofol versus dexmedetomidine) in awake implantation of neuromodulative systems

Not Applicable

Completed

• Conditions: Chronic pain; Signs and Symptoms

• Registration Number: ISRCTN46302353
• Lead Sponsor: Erasmus Medical Center

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31321763 results (added 16/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-03
• Study Completion: 2018-04-20
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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