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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03251222
Other study ID # UKC-OCKL1
Secondary ID
Status Recruiting
Phase Phase 4
First received August 2, 2017
Last updated August 11, 2017
Start date January 1, 2017
Est. completion date March 1, 2018

Study information

Verified date August 2017
Source University Medical Centre Ljubljana
Contact Iztok Potocnik, PHD
Phone 0038615228191
Email iztokpotocnik@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 1, 2018
Est. primary completion date December 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
Intranasal aplication of dexmedetomidine
Other:
Placebo - Concentrate
Intranasal aplication of 0.9% NaCl

Locations

Country Name City State
Slovenia UMCLjubljana, CD of Anaesthesiology and Intensive Therapy Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (6)

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 protoco — View Citation

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 — View Citation

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 — View Citation

Martinez-Simon A, Cacho-Asenjo E, Hernando B, Honorato-Cia C, Naval L, Panadero A, Nuñez-Cordoba JM. Loading dose of Dexdor(®) and optimal sedation during oral and maxillofacial ambulatory surgery procedures: An observational study. Rev Esp Anestesiol Rea — View Citation

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. — View Citation

Xu J, Deng XM, Yang D, Wei LX, Zhi J, Xu WL, Liu JH. Comparison of Sedative Effects of Two Spray Administration of Intranasal <br/>Dexmedetomidine Doses for Premedication in Children. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2016 Oct 10;38(5):563-567. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other BIS- bispectral index Depth of the sedation duration of the procedure
Primary remifentanil consuption the consuption of remifentanil requiered to reach the appropriate sedation will be meassured duration of the procedure
Secondary Oxigen Saturation Oxigen Saturation measured with pulse oxymetry duration of the procedure
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