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Clonidine als toevoeging voor de verlenging van pijnbestrijding bij oogoperaties.

Completed
Conditions
Anaesthesia for patients scheduled for retinal cryocoagulation and episcleral explant, or cryocoagulation of ciliary body.
Registration Number
NL-OMON25087
Lead Sponsor
Oogziekenhuis Rotterdam (OZR)Postbus 700303000 LM, Rotterdam
Brief Summary

Górniak M, Proost JH, Veckeneer M, Mulder VC, Wubbels RJ. Clonidine as an adjuvant to prolong local analgesia in conventional scleral buckle surgery. J Ocul Pharmacol Ther. 2014; Sep 4 [Epub ahead of print]. PubMed PMID: 25188774

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
108
Inclusion Criteria

1. Age ≥ 18 years;

2. Informed consent;

Exclusion Criteria

1. Hypersensitivity to clonidine or any other ingredients in the product;

2. Severe bradyarrhythmia as a result of sick sinus syndrome or 2nd or 3rd degree AV block;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Maximal pain level (VAS-score);<br /><br>2. Time of maximal post-operative pain;<br /><br>3. Amount of escape medication used;<br /><br>4. Time of use.
Secondary Outcome Measures
NameTimeMethod
1. Pharmacokinetics of clonidine will be investigated in 4 men and 4 women;<br /><br>2. Serum level of clonidine (LC-MS/MS) at 30, 60, 90 and 240 minutes after retrobulbar injection, and at postoperative day. Detection limit will be at least 0.1 µg/l.
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