Anaesthesia for patients scheduled for retinal cryocoagulation and episcleral explant, or cryocoagulation of ciliary body.
Conditions
Interventions
The investigational product of this study is clonidine, which will be used as an adjuvant in retrobulbar block. The efficacy of clonidine will be compared with a control group.
Group 1: Retrobulbar,
Group 2: Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml + clonidine 150 µg in 1 ml.
Sponsors
Oogziekenhuis Rotterdam (OZR)
Postbus 70030
3000 LM, Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ≥ 18 years; 2. Informed consent; 3. Rhegmatogenous retinal detachment requiring cryocoagulation and episcleral explant; 4. Glaucoma requiring cryocoagulation of the ciliary body.
Exclusion criteria
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; 3. Use of oral clonidine; 4. Lapp lactase deficiency or glucose-galactose malabsorption; 5. Bipolar disorder; 6. History of renal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maximal pain level (VAS-score); 2. Time of maximal post-operative pain; 3. Amount of escape medication used; 4. Time of use. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics of clonidine will be investigated in 4 men and 4 women; 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. | — |
Contacts
Public ContactM. Górniak
The Rotterdam Eye Hospital / Rotterdam Ophthalmic Institute PO Box 70030
Outcome results
None listed