Trial Outcomes & Findings for Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety (NCT NCT00928772)
NCT ID: NCT00928772
Last Updated: 2017-04-20
Results Overview
Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
115 participants
Primary outcome timeframe
during the cataract surgery up to30 minutes
Results posted on
2017-04-20
Participant Flow
Participant milestones
| Measure |
Alpha-Stim Intervention
One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION
|
Sham Alpha-Stim With Midazolam
Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
|
Placebo
No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
38
|
|
Overall Study
COMPLETED
|
39
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety
Baseline characteristics by cohort
| Measure |
Alpha-Stim Intervention
n=39 Participants
One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION
|
Sham Alpha-Stim With Midazolam
n=38 Participants
Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
|
Placebo
n=38 Participants
No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
50-90 years
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during the cataract surgery up to30 minutesAnxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.
Outcome measures
| Measure |
Alpha-Stim Intervention
n=39 Participants
One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION
|
Sham Alpha-Stim With Midazolam
n=38 Participants
Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
|
Placebo
n=38 Participants
No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
|
|---|---|---|---|
|
Anxiety During Cataract Surgery Under Topical Anesthesia
|
3.19 units on a scale
Interval 1.0 to 8.0
|
2.96 units on a scale
Interval 1.0 to 9.0
|
4.10 units on a scale
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: during cataract surgery up to 30 minutesVAS from 0 to 10 with 10 being maximal discomfort percieved
Outcome measures
| Measure |
Alpha-Stim Intervention
n=39 Participants
One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION
|
Sham Alpha-Stim With Midazolam
n=38 Participants
Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
|
Placebo
n=38 Participants
No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
|
|---|---|---|---|
|
Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia
|
2.58 units on a scale
Interval 1.0 to 7.0
|
2.66 units on a scale
Interval 1.0 to 8.0
|
2.79 units on a scale
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: during cataract surgery up to 30 minutesOutcome measures
| Measure |
Alpha-Stim Intervention
n=39 Participants
One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION
|
Sham Alpha-Stim With Midazolam
n=38 Participants
Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
|
Placebo
n=38 Participants
No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
|
|---|---|---|---|
|
Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia
|
99.5 mmHg
Interval 74.6 to 135.3
|
99.8 mmHg
Interval 66.7 to 126.3
|
104.5 mmHg
Interval 79.0 to 124.5
|
SECONDARY outcome
Timeframe: during cataract surgery up to 30 minutesOutcome measures
| Measure |
Alpha-Stim Intervention
n=39 Participants
One hour Alpha-Stim intervention with sham midazolam
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION
|
Sham Alpha-Stim With Midazolam
n=38 Participants
Sham Alpha-Stim intervention with real midazolam administration
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
|
Placebo
n=38 Participants
No Alpha-Stim and only topical anesthetics
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
|
|---|---|---|---|
|
Heart Rate During Cataract Surgery Under Topical Anesthesia
|
64.6 Beats per minute
Interval 53.0 to 88.0
|
65.4 Beats per minute
Interval 48.0 to 80.0
|
67.9 Beats per minute
Interval 47.0 to 98.0
|
Adverse Events
Alpha-Stim Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Alpha-Stim With Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place