Clonidine as an adjuvant to prolong local anaesthesia in ophthalmic surgery with cryocoagulation. A randomized, controlled, patient-masked trial. - Retrobulbar clonidine

Phase 1

Active, not recruiting

• Conditions: - Rhegmatogenous retinal detachment requiring cryocoagulation and episcleral explant.- Glaucoma requiring cryocoagulation of the ciliary body.

• Registration Number: EUCTR2010-024100-10-NL
• Lead Sponsor: The Rotterdam Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-24
• Study Completion: 2013-05-03
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

- Age = 18 years.
- Informed consent.
- Rhegmatogenous retinal detachment requiring cryocoagulation and episcleral explant.
- Glaucoma requiring cryocoagulation of the ciliary body.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
- Cerebrovascular disease, heart failure, coronary insufficiency, occlusive peripheral vascular disorder.
- Lapp lactase deficiency or glucose-galactose malabsorption.
- Bipolar disorder.
- All (other) contraindications and warnings mentioned in the Summary of Product Characteristics of Catapresan.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the beneficial effect of a single dose of 150 µg clonidine as an adjuvant to chirocaine in retrobulbar block.;Secondary Objective: To obtain an estimate of the pharmacokinetic properties of clonidine after retrobulbar injection.;Primary end point(s): Maximal pain level.<br>Time of maximal post-operative pain. <br>Amount of escape medication used.<br>Time of use.<br>