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

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ClinicalTrials.gov Identifier: NCT03897985
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Tracking Information
First Submitted Date March 29, 2019
First Posted Date April 1, 2019
Last Update Posted Date April 3, 2019
Estimated Study Start Date May 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2019)
Correlation of anesthesia depth measured by Narcotrend TM and quality of ECT treatment [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03897985 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measurement of Anaesthesia-depth Trough Narcotrend TM in Patients Undergoing Electro-Convulsion-Therapy (ECT)- Influence of Anasthesia Depth on Quality of Convulsion
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient sceduled for elective ECT for the Treatment of severe deppression
Condition Anesthesia
Intervention Device: Narcotrend TM
Measurement of anesthesia depth
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 29, 2019)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ASA (American Society of Anesthesiologists) Physical Satus I-3
  • >18 years < 90 years
  • Signed informed consent

Exclusion Criteria:

  • Refusal of the patient
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03897985
Other Study ID Numbers Narcotrend-ECT Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Medical University Innsbruck
Study Sponsor Medical University Innsbruck
Collaborators Not Provided
Investigators Not Provided
PRS Account Medical University Innsbruck
Verification Date March 2019