Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2017-01-01
2018-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation
NCT04815265
Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli
NCT01076790
Effects of Two Different Sedation Regimes on Auditory Evoked Potentials and Electroencephalogram (EEG)
NCT00641563
Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and Ropivacaine
NCT04697537
Controlled Sedation for Cataract Surgery
NCT03401606
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Remifentanil is currently used for intravenous infusion for analgesia and anxiolysis. Remifentanil is an opioid analgesic, which also works partially anxiolytically. It has been studied in detail for postnatal analgesia (2). 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 and a rapidly shallow sedation can pass into the deeper. Remifentanil is also very unpredictable and it is very difficult to control it during the operation, so that the patient is satisfactorily analgesized at all times, but still co-operable.
Recently, dexmedetomidine (3-5) has been successfully used in other areas of surgery (eg neurosurgery, maxillofacial surgery, ORL) and intensive sedation therapies. 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 (3).
Dexmedetomidine is predominantly administered intravenously, and intranasal administration (6-8) has also been established in pediatric patients.
We decided to use intranasal use because it is simple, safe and suitable for such treatments because intravenous dexmedetomidine could not be administered because it should be given enough time before surgery (at least 40 min) because otherwise the appropriate effect . Patients for such operations will enter the operating room directly from the departments on foot and dexmedetomidine could not be started earlier, as it is not possible to provide adequate control in the department. A sedentary patient would also not be able to walk into an operational one, which would greatly complicate and also increase logistics.
The study is applicable, as it will provide objective indicators, which type of sedation is most effective and safe for vitreoretinal interventions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dexmedetomidine group
Patients who will receive Dexmedetomidine intranasal prior the sedation with remifentanil
Dexmedetomidine
Intranasal aplication of dexmedetomidine
Placebo Concentrate
Patients will recive 0.9% NaCl
Placebo - Concentrate
Intranasal aplication of 0.9% NaCl
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexmedetomidine
Intranasal aplication of dexmedetomidine
Placebo - Concentrate
Intranasal aplication of 0.9% NaCl
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Medical Centre Ljubljana
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Iztok Potocnik
M.D., PHD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vesna Novak-Jankovic, PROF
Role: STUDY_CHAIR
UMCLjubljana, KOAIT
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UMCLjubljana, CD of Anaesthesiology and Intensive Therapy
Ljubljana, , Slovenia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Das 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.
Martinez-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.
Xu 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.
Ghai 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.
Bonanno 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UKC-OCKL1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.