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Clonidine - Ropivacaine in Peribulbar Anesthesia (CRAPO)

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ClinicalTrials.gov Identifier: NCT01963299
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine.

The aim of the study is to prove that the association of Clonidine with Ropivacaine is more effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.

The principal interest of this association of drugs is that it procures faster and longer anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides greater comfort to the patient during and after the intervention.


Condition or disease Intervention/treatment Phase
Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia Drug: 5 ml Ropivacaine 10% + physiological saline Drug: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomised Double-blind Study to Compare Ropivacaine 10mg/mL Alone Versus Ropivacaine 10mg/mL Associated With Clonidine 1µg/kg for Peribulbar Anesthesia in Posterior Eye Surgery
Study Start Date : August 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ropivacaine alone group Drug: 5 ml Ropivacaine 10% + physiological saline
Experimental: Ropivacaine/Clonidine group Drug: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg



Primary Outcome Measures :
  1. Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia [ Time Frame: up to 1 hour ]

Secondary Outcome Measures :
  1. Time to achieve akinesia [ Time Frame: up to 1 hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who have given written informed consent
  • any adult patient about to undergo their first operation involving the posterior segment of the eye under peribulbar anaesthesia

Exclusion Criteria:

  • persons without National Health Insurance
  • pregnant or breast-feeding women, patients < 18, patients who cannot give their consent, patient's refusal of Loco-Regional Anesthesia, patients who cannot remain in dorsal decubitus dorsal for at least 1h
  • contra-indication for Loco-Regional Anesthesia
  • hypersensitivity to the study drugs (ropivacaine, clonidine), to the corresponding excipients or hypersensitivity to local anaesthetics other than amide-type ropivacaine.
  • disorders of periorbital or oculomotor sensitivity, patients with glaucoma, patients with chronic pain and on morphines
  • uncontrolled arterial hypertension, clonidine per os at home, arterial hypotension before the intervention (SAP < 90 mmHg)
  • Surgery for diabetic retinopathy, patients with unbalanced diabetes, eye with prior posterior segment surgery
  • Contra-indications mentioned on the summary of product characteristics for clonidine (known hypersensitivity to the active ingredients or one of its excipients, Heart rate below 60bpm, severe Bradycardia due to sinoatrial node disease or second or third degree atrioventricular block, Depression, Sultopride).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963299


Locations
France
CHU Dijon
Dijon, France, 21
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01963299     History of Changes
Other Study ID Numbers: GIRARD-BERTRAND 2013
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Clonidine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action