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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024100-10-NL

Enrollment

100

Registered

2010-11-24

Start date

2011-03-28

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

None listed

Interventions

Trade Name: Catapresan Product Name: Catapresan Product Code: RVG 06055 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. Time of maximal post-operative pain. Amount of escape medication used. Time of use.	—

Countries

Netherlands

Outcome results