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Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia

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ClinicalTrials.gov Identifier: NCT02733757
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
Federal University of Espirito Santo
Information provided by (Responsible Party):
Renato Santiago Gomez, Federal University of Minas Gerais

Brief Summary:
Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and peribulbar anesthesia.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Clonidine Phase 2

Detailed Description:
In this prospective randomized and double blind clinical study, involving 80 patients with ages from 30 to 86 years old, ASA I and II, both genders. The patients were randomly divided into 4 groups of 20 patients, and then were administered in control sub-Tenon's group 5 mL of 2% lidocaine with 1 mL of 0.9% sodium chloride solution; in sub-Tenon's group clonidine, 5 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. In the peribulbar anesthesia, the control group with 6 mL of 2% lidocaine and 1 mL of 0.9% sodium chloride solution, and peribulbar group clonidine, 6 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. Were evaluated the systemic hemodynamic variables; IOP and OPA measurements according the dynamic contour tonometer (DCT) and calculation of OPP, prior to the blockade (M0), and one (M1), five (5) and ten minutes (M10) after the injection of the anesthetic solutions. Complications related to the sub-Tenon's and peribulbar anesthesia were recorded.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Clonidine Added to Lidocaine in Sub-Tenon's and Peribulbar Anesthesia: Assessments of Intraocular Pressure (IOP), Ocular Perfusion Pressure (OPP) and Ocular Pulse Amplitude (OPA)
Study Start Date : May 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Sub-Tenon's group control
2% Lidocaine without epinephrine
Experimental: Sub-Tenon's group clonidine
2% Lidocaine without epinephrine plus clonidine 1 µg/kg
Drug: Clonidine
Clonidine 1 µg/kg plus 2% lidocaine
Other Name: Atensine

No Intervention: Peribulbar group control
2% Lidocaine without epinephrine
Experimental: Peribulbar group clonidine
2% Lidocaine without epinephrine plus clonidine 1 µg/kg
Drug: Clonidine
Clonidine 1 µg/kg plus 2% lidocaine
Other Name: Atensine




Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: Within 10 minutes before the surgery procedure ]
  2. ocular perfusion pressure (PPO) [ Time Frame: Within 10 minutes before the surgery procedure ]
  3. ocular pulse amplitude (OPA) [ Time Frame: Within 10 minutes before the surgery procedure ]


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Ages Eligible for Study:   30 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults between 30 and 86 years old
  • Both genders
  • Physical status ASA (American Society of Anesthesiologists) I and II
  • Cooperative patients undergoing cataract surgery by phacoemulsification

Exclusion Criteria:

  • Patients with communication difficulties
  • Allergic to any medication protocol
  • Chronic therapy with clonidine
  • In use of antihypertensive medication
  • Diabetes
  • Glaucoma
  • Previous surgery in the same eye
  • Abnormalities in coagulation

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): NCT02733757


Sponsors and Collaborators
Federal University of Minas Gerais
Federal University of Espirito Santo
Investigators
Principal Investigator: Sigmar Cabral, PhD Federal University of Espírito Santo, Vitória
Study Director: Renato Gomez, PhD Federal University of Minas Gerais, Belo Horizonte

Publications:
Responsible Party: Renato Santiago Gomez, Head of surgery department of the medical school of the Federal University of Minas Gerais, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02733757     History of Changes
Other Study ID Numbers: CAAE - 03409512.2.0000.5149
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Renato Santiago Gomez, Federal University of Minas Gerais:
Clonidine
Sub-Tenon's and Peribulbar block
IOP
OPP
OPA

Additional relevant MeSH terms:
Clonidine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents