NCT02733757

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

August 25, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

March 15, 2016

Results QC Date

August 11, 2020

Last Update Submit

August 11, 2020

Conditions

Anesthesia

Keywords

ClonidineSub-Tenon's and Peribulbar blockIOPOPPOPA

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP)

    Within 10 minutes before the surgery procedure

Study Arms (4)

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

Drug: Clonidine

Peribulbar group control

NO INTERVENTION

2% Lidocaine without epinephrine

Peribulbar group clonidine

EXPERIMENTAL

2% Lidocaine without epinephrine plus clonidine 1 µg/kg

Drug: Clonidine

Interventions

ClonidineDRUG

Clonidine 1 µg/kg plus 2% lidocaine

Also known as: Atensine
Peribulbar group clonidineSub-Tenon's group clonidine

Eligibility Criteria

Age30 Years - 86 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 11524193BACKGROUND

  • Watkins 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.

    PMID: 11423451BACKGROUND

  • Cabral 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.

    PMID: 23797624BACKGROUND

MeSH Terms

Interventions

ClonidineDiazepam

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr Renato Gomez
Organization
Universidade federal de Minas Gerais
renatogomez2000@yahoo.com.br
553134099760

Study Officials

  • Sigmar Cabral, PhD

    Federal University of Espírito Santo, Vitória

    PRINCIPAL INVESTIGATOR

  • Renato Gomez, PhD

    Federal University of Minas Gerais, Belo Horizonte

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of surgery department of the medical school of the Federal University of Minas Gerais

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 11, 2016

Study Start

May 1, 2013

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

August 25, 2020

Results First Posted

August 25, 2020

Record last verified: 2020-08