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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2820 |
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Date of registration:
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24/03/2011 |
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Primary sponsor: |
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Public title:
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Clonidine als toevoeging voor de verlenging van pijnbestrijding bij oogoperaties.
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Scientific title:
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Clonidine as an adjuvant to prolong local anaesthesia in ophthalmic surgery with cryocoagulation. A randomized, controlled, double-blind trial.
- NA |
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Date of first enrolment:
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1/5/2011 |
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Target sample size:
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108 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2820 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Not applicable; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.
Górniak |
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Address:
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The Rotterdam Eye Hospital /
Rotterdam Ophthalmic Institute
PO Box 70030
3000 LM
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 4017777 |
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Email:
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m.gorniak@oogziekenhuis.nl |
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Affiliation:
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Name:
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M.
Górniak |
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Address:
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The Rotterdam Eye Hospital /
Rotterdam Ophthalmic Institute
PO Box 70030
3000 LM
Rotterdam
The Netherlands |
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Telephone:
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+31 (0)10 4017777 |
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Email:
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m.gorniak@oogziekenhuis.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Anesthesia, Retinal cryocoagulation, Episcleral explant
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Intervention(s)
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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, Chirocaine 7.5 mg/ml: 3-5 ml;
Group 2: Retrobulbar, Chirocaine 7.5 mg/ml: 3-5 ml + clonidine 150 µg in 1 ml.
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Primary Outcome(s)
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1. Maximal pain level (VAS-score);
2. Time of maximal post-operative pain;
3. Amount of escape medication used;
4. Time of use.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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OZR-2010-17 / NL34843.078.10;
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Source(s) of Monetary Support
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Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
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