Conscious SedationPhase 4NCT03251222
Intranasal Sedation With Dexmedetomidine
A Phase 4 study testing Dexmedetomidine in people with Conscious Sedation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2017to 1 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
UMCLjubljana, CD of Anaesthesiology and Intensive Therapy
Ljubljana, 1000
Vesna Novak Jankovic, MD, PROF, +38615222930, vnovakjankovic@gmail.com
Iztok Potocnik, MD, PHD
About this study
Official title: Intranasal Sedation With Dexmedetomidine for Vitroretinal Procedures
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.
Read the detailed description
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 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
- Conscious Sedation
- Being tested
- Dexmedetomidine, Placebo - Concentrate
- Keywords
- conscious sedation, vitroretinal procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intranasal aplication of dexmedetomidine
Placebo - ConcentrateOther
Also called Placebo
Intranasal aplication of 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Patients who will receive Dexmedetomidine intranasal prior the sedation with remifentanil Receives: Drug: Dexmedetomidine |
| Placebo Concentrate | Placebo comparator | Patients will recive 0.9% NaCl Receives: Other: Placebo - Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
remifentanil consuption
the consuption of remifentanil requiered to reach the appropriate sedation will be meassured
Measured: duration of the procedure
Secondary outcomes (1)
Oxigen Saturation
Oxigen Saturation measured with pulse oxymetry
Measured: duration of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Jan 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iztok Potocnik, University Medical Centre Ljubljana
- Investigators
- Vesna Novak-Jankovic, PROF, Study chair, UMCLjubljana, KOAIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251222
- Sponsor's protocol ID
- UKC-OCKL1
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27770212Das 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.
PubMed 27606116Martinez-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.
PubMed 27825666Xu 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.
PubMed 27825415Ghai 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.
PubMed 27734549Bonanno 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.
PubMed 27635747
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Sedation With Dexmedetomidine for Vitroretinal Procedures
- ClinicalTrials.gov ID
- NCT03251222
- Acronym / sponsor ID
- UKC-OCKL1
- Conditions
- Conscious Sedation
- Keywords
- conscious sedation, vitroretinal procedures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients who will receive Dexmedetomidine intranasal prior the sedation with remifentanil |
| Placebo Concentrate | Placebo comparator | Other: Placebo - ConcentratePatients will recive 0.9% NaCl |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineIntranasal aplication of dexmedetomidine | Drug | Dexmedetomidine group |
| Placebo - ConcentrateAlso: PlaceboIntranasal aplication of 0.9% NaCl | Other | Placebo Concentrate |
Primary outcome
remifentanil consuption
Time frame: duration of the procedure
the consuption of remifentanil requiered to reach the appropriate sedation will be meassured
1 secondary outcome
Oxigen Saturation
Time frame: duration of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Results publication: PubMed 27770212Ohashi 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.
- Results publication: PubMed 27606116Das 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.
- Results publication: PubMed 27825666Martinez-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.
- Results publication: PubMed 27825415Xu 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.
- Results publication: PubMed 27734549Ghai 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.
- Results publication: PubMed 27635747Bonanno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vesna Novak-Jankovic, PROF study chair
UMCLjubljana, KOAIT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Conscious Sedation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iztok Potocnik, PHD (0038615228191, iztokpotocnik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remifentanil consuption (time frame: duration of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251222, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.