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Intranasal Sedation With Dexmedetomidine

Intranasal Sedation With Dexmedetomidine for Vitroretinal Procedures

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03251222
Enrollment
40
Registered
2017-08-16
Start date
2017-01-01
Completion date
2018-03-01
Last updated
2017-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation

Keywords

conscious sedation, vitroretinal procedures

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.

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.

Interventions

DRUGDexmedetomidine

Intranasal aplication of dexmedetomidine

Intranasal aplication of 0.9% NaCl

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
remifentanil consuptionduration of the procedurethe consuption of remifentanil requiered to reach the appropriate sedation will be meassured

Secondary

MeasureTime frameDescription
Oxigen Saturationduration of the procedureOxigen Saturation measured with pulse oxymetry

Other

MeasureTime frameDescription
BIS- bispectral indexduration of the procedureDepth of the sedation

Countries

Slovenia

Contacts

Primary ContactIztok Potocnik, PHD
iztokpotocnik@gmail.com0038615228191
Backup ContactJasmina Markovic-Bozic, PHD
jasmina.markovic1@gmail.com00386152218191

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026