CRAPO: Clonidine - Ropivacaine in Peribulbar Anesthesia

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT01963299

Collaborator

(none)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

35.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Aug 16, 2013

Actual Primary Completion Date :

Oct 7, 2013

Actual Study Completion Date :

Oct 7, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia [up to 1 hour]

Secondary Outcome Measures

Time to achieve akinesia [up to 1 hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon	Dijon		France	21

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT01963299

Other Study ID Numbers:

GIRARD-BERTRAND 2013

First Posted:

Oct 16, 2013

Last Update Posted:

Jan 10, 2019

Last Verified:

Jan 1, 2019

Additional relevant MeSH terms:

Clonidine

Ropivacaine

Study Results

No Results Posted as of Jan 10, 2019