Clonidine as an adjuvant to prolong local anaesthesia in ophthalmic surgery with cryocoagulation. A randomized, controlled, double-blind trial.
Phase 3
Completed
- Conditions
- Rhegmatogenous retinal detachment & glaucoma requiring cryocoagulation10015917
- Registration Number
- NL-OMON36352
- Lead Sponsor
- Oogziekenhuis Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
Inclusion Criteria
- Age >= 18 years.
- Informed consent.
- Rhegmatogenous retinal detachment requiring cryocoagulation and episcleral explant.
- Glaucoma requiring cryocoagulation of the ciliary body.
Exclusion Criteria
- Hypersensitivity to clonidine or any other ingredients in the product.
- Severe bradyarrhythmia as a result of sick sinus syndrome or 2nd or 3rd degree AV block.
- Use of oral clonidine.
- Lapp lactase deficiency or glucose-galactose malabsorption.
- Bipolar disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Maximal pain level, time of maximal post-operative pain, amount of escape<br /><br>medication used, time of use.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Serum level of clonidine at 30, 60, 90 and 240 minutes after retrobulbar<br /><br>injection, and at postoperative day. </p><br>