Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

Phase 4

Terminated

• Conditions: Anxiety
• Interventions: Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM; Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED; Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY

• Registration Number: NCT00928772
• Lead Sponsor: University of Oklahoma

Brief Summary

Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.

Detailed Description

CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.

Study Timeline

• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Study Start: 2009-07
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2017-04
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-04-20
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• Patients of both genders between 50 and 90 years old scheduled for an outpatient "first eye" cataract phacoemulsification with topical anesthesia.
• ASA classification I II and III

Exclusion Criteria

• ASA classification IV (patients with a chronic or severe disease).
• Hypersensitivity to midazolam or benzodiazepines
• acute narrow-angle glaucoma
• untreated open-angle glaucoma
• Patients with any sort of psychiatric or neurological disorder
• Patients on anti-anxiety medication
• Patients who have demand-type pacemakers installed before 1999* *Note: These are the exclusions listed for liability purposes by Alpha-Stim. There are no FDA exclusions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alpha-Stim intervention	CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM	One hour Alpha-Stim intervention with sham midazolam
Placebo	NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED	No Alpha-Stim and only topical anesthetics
Sham Alpha-Stim with midazolam	MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY	Sham Alpha-Stim intervention with real midazolam administration

Primary Outcome Measures

Name	Time	Method
Anxiety During Cataract Surgery Under Topical Anesthesia	during the cataract surgery up to30 minutes	Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.

Secondary Outcome Measures

Name	Time	Method
Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia	during cataract surgery up to 30 minutes	VAS from 0 to 10 with 10 being maximal discomfort percieved
Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia	during cataract surgery up to 30 minutes
Heart Rate During Cataract Surgery Under Topical Anesthesia	during cataract surgery up to 30 minutes

Trial Locations

Locations (1)

Oklahoma City VA Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States