Intranasal Sedation With Dexmedetomidine
1 other identifier
interventional
40
1 country
1
Brief Summary
For patients with eye surgery and shorter surgery, sedation is a well-established method in preserved consciousness and has been successfully used for several years. We have also developed and published a valid protocol (1). Remifentanil is used in intravenous infusion for sedation and anxiolysis. Remifentanil is a descriptive analgesic, which also works partially anxiolytically. In eye surgery, it is important that the patient cooperates during the operation and should not be ashamed, as injury to the eye could occur, because the vitrectomes are performed with a fine intraocular endoscopic technique, in which the operator inserts his instruments through the whiteness into the eye. For this reason, we have not yet added additional sedatives (for example, midazolam), which is very unpredictable as regards sedation. Remifentanil is also very unpredictable and it is very difficult to control it during the operation so that the patient is saturated with satisfaction. Lately, dexmedetomidine has been successfully used in sedation for other areas of surgery (eg neurosurgery, maxillofacial surgery, ORL). It is a safe, proven, active substance with alpha 2 agonistic effect, which has not yet been used in the field of ocular surgery and has not yet published articles in this field. The substance is very suitable because it works mildly sedative and at the same time analgesic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 2, 2017
CompletedFirst Posted
Study publicly available on registry
August 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedAugust 16, 2017
August 1, 2017
11 months
August 2, 2017
August 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
remifentanil consuption
the consuption of remifentanil requiered to reach the appropriate sedation will be meassured
duration of the procedure
Secondary Outcomes (1)
Oxigen Saturation
duration of the procedure
Other Outcomes (1)
BIS- bispectral index
duration of the procedure
Study Arms (2)
Dexmedetomidine group
EXPERIMENTALPatients who will receive Dexmedetomidine intranasal prior the sedation with remifentanil
Placebo Concentrate
PLACEBO COMPARATORPatients will recive 0.9% NaCl
Interventions
Intranasal aplication of 0.9% NaCl
Eligibility Criteria
You may not qualify if:
- patients who will not want to be operated in the sedation but in general anesthesia
- poor general condition (ASA\> 3)
- with severe cardiac disease (NYHA\> 3)
- with severe pulmonary obstructive disease (FEV1 \<40%)
- neurological diseases
- psychiatric patients
- patients receiving regular psychotropic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMCLjubljana, CD of Anaesthesiology and Intensive Therapy
Ljubljana, 1000, Slovenia
Related Publications (6)
Ohashi Y, Baghirzada L, Sumikura H, Balki M. Erratum to: Remifentanil for labor analgesia: a comprehensive review. J Anesth. 2017 Feb;31(1):160. doi: 10.1007/s00540-016-2269-z. No abstract available.
PMID: 27770212RESULTDas S, Al-Mashani A, Suri N, Salhotra N, Chatterjee N. Combination of Continuous Dexmedetomidine Infusion with Titrated Ultra-Low-Dose Propofol-Fentanyl for an Awake Craniotomy. Sultan Qaboos Univ Med J. 2016 Aug;16(3):e347-51. doi: 10.18295/squmj.2016.16.03.014. Epub 2016 Aug 19.
PMID: 27606116RESULTMartinez-Simon A, Cacho-Asenjo E, Hernando B, Honorato-Cia C, Naval L, Panadero A, Nunez-Cordoba JM. Loading dose of Dexdor(R) and optimal sedation during oral and maxillofacial ambulatory surgery procedures: An observational study. Rev Esp Anestesiol Reanim. 2017 Apr;64(4):206-213. doi: 10.1016/j.redar.2016.08.005. Epub 2016 Nov 5. English, Spanish.
PMID: 27825666RESULTXu J, Deng XM, Yang D, Wei LX, Zhi J, Xu WL, Liu JH. Comparison of Sedative Effects of Two Spray Administration of Intranasal Dexmedetomidine Doses for Premedication in Children. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2016 Oct 10;38(5):563-567. doi: 10.3881/j.issn.1000-503X.2016.05.013.
PMID: 27825415RESULTGhai B, Jain K, Saxena AK, Bhatia N, Sodhi KS. Comparison of oral midazolam with intranasal dexmedetomidine premedication for children undergoing CT imaging: a randomized, double-blind, and controlled study. Paediatr Anaesth. 2017 Jan;27(1):37-44. doi: 10.1111/pan.13010. Epub 2016 Oct 13.
PMID: 27734549RESULTBonanno LS, Pierce S, Badeaux J, FitzSimons JJ. Effectiveness of preoperative intranasal dexmedetomidine compared with oral midazolam for the prevention of emergence delirium in pediatric patients undergoing general anesthesia: a systematic review protocol. JBI Database System Rev Implement Rep. 2016 Aug;14(8):70-9. doi: 10.11124/JBISRIR-2016-003059.
PMID: 27635747RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Vesna Novak-Jankovic, PROF
UMCLjubljana, KOAIT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PHD
Study Record Dates
First Submitted
August 2, 2017
First Posted
August 16, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
August 16, 2017
Record last verified: 2017-08