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Intranasal Sedation With Dexmedetomidine

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ClinicalTrials.gov Identifier: NCT03251222
Recruitment Status : Unknown
Verified August 2017 by Iztok Potocnik, University Medical Centre Ljubljana.
Recruitment status was:  Recruiting
First Posted : August 16, 2017
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Iztok Potocnik, University Medical Centre Ljubljana

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.


Condition or disease Intervention/treatment Phase
Conscious Sedation Drug: Dexmedetomidine Other: Placebo - Concentrate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Sedation With Dexmedetomidine for Vitroretinal Procedures
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine group
Patients who will receive Dexmedetomidine intranasal prior the sedation with remifentanil
Drug: Dexmedetomidine
Intranasal aplication of dexmedetomidine

Placebo Comparator: Placebo Concentrate
Patients will recive 0.9% NaCl
Other: Placebo - Concentrate
Intranasal aplication of 0.9% NaCl
Other Name: Placebo




Primary Outcome Measures :
  1. remifentanil consuption [ Time Frame: duration of the procedure ]
    the consuption of remifentanil requiered to reach the appropriate sedation will be meassured


Secondary Outcome Measures :
  1. Oxigen Saturation [ Time Frame: duration of the procedure ]
    Oxigen Saturation measured with pulse oxymetry


Other Outcome Measures:
  1. BIS- bispectral index [ Time Frame: duration of the procedure ]
    Depth of the sedation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: patients who will be operated on the eye (vitreoretinal interventions) patients with ASA status 1-3

-

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251222


Contacts
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Contact: Iztok Potocnik, PHD 0038615228191 iztokpotocnik@gmail.com
Contact: Jasmina Markovic-Bozic, PHD 00386152218191 jasmina.markovic1@gmail.com

Locations
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Slovenia
UMCLjubljana, CD of Anaesthesiology and Intensive Therapy Recruiting
Ljubljana, Slovenia, 1000
Contact: Vesna Novak Jankovic, MD, PROF    +38615222930    vnovakjankovic@gmail.com   
Principal Investigator: Iztok Potocnik, MD, PHD         
Sub-Investigator: Jasmina Markovic-Bozic, MD, PHD         
Sub-Investigator: Dragana Markovic, MD         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Study Chair: Vesna Novak-Jankovic, PROF UMCLjubljana, KOAIT

Publications of Results:

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Responsible Party: Iztok Potocnik, M.D., PHD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03251222    
Other Study ID Numbers: UKC-OCKL1
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Keywords provided by Iztok Potocnik, University Medical Centre Ljubljana:
conscious sedation, vitroretinal procedures
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action