AnesthesiaPhase 2NCT02733757
Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia
A Phase 2 study testing Clonidine in people with Anesthesia, run by Federal University of Minas Gerais.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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)
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Clonidine
- Keywords
- Clonidine, Sub-Tenon's and Peribulbar block, IOP, OPP, OPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
Also called Atensine
Clonidine 1 µg/kg plus 2% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Sub-Tenon's group control | No intervention | 2% Lidocaine without epinephrine |
| Sub-Tenon's group clonidine | Experimental | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Receives: Drug: Clonidine |
| Peribulbar group control | No intervention | 2% Lidocaine without epinephrine |
| Peribulbar group clonidine | Experimental | 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Measured: Within 10 minutes before the surgery procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startMay 2013
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Espirito Santo
- Responsible party
- Principal investigator, Renato Santiago Gomez, Federal University of Minas Gerais
- Investigators
- Sigmar Cabral, PhD, Principal investigator, Federal University of Espírito Santo, VitóriaRenato Gomez, PhD, Study director, Federal University of Minas Gerais, Belo Horizonte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733757
- Sponsor's protocol ID
- CAAE - 03409512.2.0000.5149
- Status last verified
- Aug 2020
- First submitted
- 15 Mar 2016
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Pianka P, Weintraub-Padova H, Lazar M, Geyer O. Effect of sub-Tenon's and peribulbar anesthesia on intraocular pressure and ocular pulse amplitude. J Cataract Refract Surg. 2001 Aug;27(8):1221-6. doi: 10.1016/s0886-3350(01)00797-0.
PubMed 11524193Watkins R, Beigi B, Yates M, Chang B, Linardos E. Intraocular pressure and pulsatile ocular blood flow after retrobulbar and peribulbar anaesthesia. Br J Ophthalmol. 2001 Jul;85(7):796-8. doi: 10.1136/bjo.85.7.796.
PubMed 11423451Cabral SA, Carraretto AR, Brocco MC, Abreu Baptista JF, Gomez RS. Effect of clonidine added to lidocaine for sub-Tenon's (episcleral) anesthesia in cataract surgery. J Anesth. 2014 Feb;28(1):70-5. doi: 10.1007/s00540-013-1660-2.
PubMed 23797624
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02733757
- Acronym / sponsor ID
- CAAE - 03409512.2.0000.5149
- Conditions
- Anesthesia
- Keywords
- Clonidine, Sub-Tenon's and Peribulbar block, IOP, OPP, OPA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Federal University of Espirito Santo
- Study start
- May 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sub-Tenon's group control | No intervention | –2% Lidocaine without epinephrine |
| Sub-Tenon's group clonidine | Experimental | Drug: Clonidine2% Lidocaine without epinephrine plus clonidine 1 µg/kg |
| Peribulbar group control | No intervention | –2% Lidocaine without epinephrine |
| Peribulbar group clonidine | Experimental | Drug: Clonidine2% Lidocaine without epinephrine plus clonidine 1 µg/kg |
Who may qualify
- Ages
- 30 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with communication difficulties
- Allergic to any medication protocol
- Chronic therapy with clonidine
- In use of antihypertensive medication
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClonidineAlso: AtensineClonidine 1 µg/kg plus 2% lidocaine | Drug | Peribulbar group clonidine, Sub-Tenon's group clonidine |
Primary outcome
Intraocular Pressure (IOP)
Time frame: Within 10 minutes before the surgery procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11524193Pianka P, Weintraub-Padova H, Lazar M, Geyer O. Effect of sub-Tenon's and peribulbar anesthesia on intraocular pressure and ocular pulse amplitude. J Cataract Refract Surg. 2001 Aug;27(8):1221-6. doi: 10.1016/s0886-3350(01)00797-0.
- Background: PubMed 11423451Watkins R, Beigi B, Yates M, Chang B, Linardos E. Intraocular pressure and pulsatile ocular blood flow after retrobulbar and peribulbar anaesthesia. Br J Ophthalmol. 2001 Jul;85(7):796-8. doi: 10.1136/bjo.85.7.796.
- Background: PubMed 23797624Cabral SA, Carraretto AR, Brocco MC, Abreu Baptista JF, Gomez RS. Effect of clonidine added to lidocaine for sub-Tenon's (episcleral) anesthesia in cataract surgery. J Anesth. 2014 Feb;28(1):70-5. doi: 10.1007/s00540-013-1660-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigmar Cabral, PhD principal investigator
Federal University of Espírito Santo, Vitória
Renato Gomez, PhD study director
Federal University of Minas Gerais, Belo Horizonte
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonidine in people with Anesthesia, run by Federal University of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (IOP) (time frame: Within 10 minutes before the surgery procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02733757, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.