A Phase 2 interventional study of Clonidine in Anesthesia, sponsored by Federal University of Minas Gerais. Completed. Open to participants aged 30 Years to 86 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-25.
Sponsored by Federal University of Minas Gerais · Phase 2, Interventional, and Treatment
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.
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.
Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2% Lidocaine without epinephrine
2% Lidocaine without epinephrine plus clonidine 1 µg/kg
Drug: Clonidine
2% Lidocaine without epinephrine
2% Lidocaine without epinephrine plus clonidine 1 µg/kg
Drug: Clonidine
Clonidine 1 µg/kg plus 2% lidocaine
Also known as: Atensine
Intraocular Pressure (IOP)
Time frame: Within 10 minutes before the surgery procedure
| Milestone | Sub-Tenon's Group Control | Sub-Tenon's Group Clonidine | Peribulbar Group Control | Peribulbar Group Clonidine |
|---|---|---|---|---|
| Started | 20 | 20 | 20 | 20 |
| Completed | 20 | 20 | 20 | 20 |
| Not completed | 0 | 0 | 0 | 0 |
| mmHg | Sub-Tenon's Group Control | Sub-Tenon's Group Clonidine | Peribulbar Group Control | Peribulbar Group Clonidine |
|---|---|---|---|---|
| Intraocular Pressure (IOP) | 18 ± 3 | 16 ± 4 | 19 ± 3 | 16 ± 4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sub-Tenon's Group Control | — | 0/20 (0%) | 0/20 (0%) |
| Sub-Tenon's Group Clonidine | — | 0/20 (0%) | 0/20 (0%) |
| Peribulbar Group Control | — | 0/20 (0%) | 0/20 (0%) |
| Peribulbar Group Clonidine | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Sub-Tenon's Group Control | Sub-Tenon's Group Clonidine | Peribulbar Group Control | Peribulbar Group Clonidine | Total |
|---|---|---|---|---|---|
| Mean | 62 ± 12 | 60 ± 13 | 64 ± 14 | 62 ± 12 | 63 ± 13 |
| Sex: Female, Male(Participants) | Sub-Tenon's Group Control | Sub-Tenon's Group Clonidine | Peribulbar Group Control | Peribulbar Group Clonidine | Total |
|---|---|---|---|---|---|
| Female | 13 | 12 | 14 | 12 | 51 |
| Male | 7 | 8 | 6 | 8 | 29 |
No study locations are listed for this record.
Plan to share: Undecided
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Federal University of Minas Gerais