NCT03897985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
Last Updated

September 3, 2020

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

March 29, 2019

Last Update Submit

September 1, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Correlation of anesthesia depth measured by Narcotrend TM and quality of ECT treatment

    1 day

Interventions

Narcotrend TMDEVICE

Measurement of anesthesia depth

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient sceduled for elective ECT for the Treatment of severe deppression

You may qualify if:

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

You may not qualify if:

  • Refusal of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Austria

Location

Related Publications (1)

  • Gasteiger L, Heil M, Horner E, Andexer J, Kemmler G, Hausmann A, Lederer W. Relationship Between Anesthesia Depth and Quality of Seizures in Patients Undergoing Electroconvulsive Therapy: A Prospective Observational Study. J ECT. 2022 Mar 1;38(1):62-67. doi: 10.1097/YCT.0000000000000792.

    PMID: 34519686DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 1, 2019

Study Start

May 1, 2019

Primary Completion

February 12, 2020

Study Completion

February 12, 2020

Last Updated

September 3, 2020

Record last verified: 2019-03

Locations

AU(1)