TM TradeMark: Measurement of Anaesthesia-depth Trough Narcotrend TM in Patients Undergoing Electro-Convulsion-Therapy (ECT)- Influence of Anasthesia Depth on Quality of Convulsion

• Sponsor: Medical University Innsbruck (Other)
• Overall Status: Completed
• CT.gov ID: NCT03897985
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 9.4
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (>15sec), the sympathic response and the postictal EEG-suppression.

For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. The goal is to find an anaesthesia-depth that is needed for the well-being of the patient and allows a good ECT.

In daily routine the dose of anesthetic agents and the assesment of anesthesia-depth is based on the subjective estimation of the anesthetist and also on ealier interventions.

The aim of the study is to assess any correlation between measured anesthesia-depth using the Narcotrend TM and the Quality of the ECT.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: Narcotrend TM

Study Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Measurement of Anaesthesia-depth Trough Narcotrend TM in Patients Undergoing Electro-Convulsion-Therapy (ECT)- Influence of Anaesthesia Depth on Quality of Convulsion - A Non-Intervention Trial
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Feb 12, 2020
• Actual Study Completion Date: Feb 12, 2020

Outcome Measures

Primary Outcome Measures

1. Correlation of anesthesia depth measured by Narcotrend TM and quality of ECT treatment [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• ASA (American Society of Anesthesiologists) Physical Satus I-3

• 18 years < 90 years

• Signed informed consent

Exclusion Criteria:

• Refusal of the patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Innsbruck	Innsbruck		Austria

Sponsors and Collaborators

• Medical University Innsbruck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT03897985
• Other Study ID Numbers: Narcotrend-ECT Study
• First Posted: Apr 1, 2019
• Last Update Posted: Sep 3, 2020
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Seizures

Study Results

No Results Posted as of Sep 3, 2020