Trial Outcomes & Findings for Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia (NCT NCT02733757)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Within 10 minutes before the surgery procedure

Results posted on

2020-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Sub-Tenon's Group Control 2% Lidocaine without epinephrine	Sub-Tenon's Group Clonidine 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine	Peribulbar Group Control 2% Lidocaine without epinephrine	Peribulbar Group Clonidine 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine
Overall Study STARTED	20	20	20	20
Overall Study COMPLETED	20	20	20	20
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sub-Tenon's Group Control n=20 Participants 2% Lidocaine without epinephrine	Sub-Tenon's Group Clonidine n=20 Participants 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine	Peribulbar Group Control n=20 Participants 2% Lidocaine without epinephrine	Peribulbar Group Clonidine n=20 Participants 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine	Total n=80 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 12 • n=5 Participants	60 years STANDARD_DEVIATION 13 • n=7 Participants	64 years STANDARD_DEVIATION 14 • n=5 Participants	62 years STANDARD_DEVIATION 12 • n=4 Participants	63 years STANDARD_DEVIATION 13 • n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	51 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	29 Participants n=21 Participants

PRIMARY outcome

Timeframe: Within 10 minutes before the surgery procedure

Outcome measures

Outcome measures
Measure	Sub-Tenon's Group Control n=20 Participants 2% Lidocaine without epinephrine	Sub-Tenon's Group Clonidine n=20 Participants 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine	Peribulbar Group Control n=20 Participants 2% Lidocaine without epinephrine	Peribulbar Group Clonidine n=20 Participants 2% Lidocaine without epinephrine plus clonidine 1 µg/kg Clonidine: Clonidine 1 µg/kg plus 2% lidocaine
Intraocular Pressure (IOP)	18 mmHg Standard Deviation 3	16 mmHg Standard Deviation 4	19 mmHg Standard Deviation 3	16 mmHg Standard Deviation 4

Adverse Events

Sub-Tenon's Group Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sub-Tenon's Group Clonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peribulbar Group Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peribulbar Group Clonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Renato Gomez

Universidade federal de Minas Gerais

Phone: 553134099760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place