Depth of Anesthesia During Electroconvulsive Therapy

NCT05308056 | Completed FDA Device

• 1 other identifier: 276915
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To describe anesthetic depth using spectal edge frequency (SEF) and density spectral array (DSA) and its relation to treatment effect of electroconvulsive therapy (ECT). Study design: Observational study Primary outcomes: SEF, DSA and treatment effect of ECT. Method: SEF and DSA si measured using a commercially available monitor for depth of anesthesia. Treatment effect of ECT will be evaluated using hemodynamic, electroencephalographic and clinical variables.

Conditions

Mood Disorders; Psychotic Disorders

Keywords

General anesthesia; Electroencephalogram; Awareness; Depth of anesthesia; Depression

Outcome Measures

Primary Outcomes (6)

• Change in spectral edge frequency

  The spectral edge frequency of the patients electroencephalogram

  Monitored before, during and after ECT. Total monitoring time is apporximately 30 minutes per patient.

• Change in density spectral array

  The density spectral array of the patients electroencephalogram

  Monitored before, during and after ECT. Total monitoring time is approximately 30 minutes per patient.

• Duration of convulsive activity

  Measures the duration of both motor and encephalographic convulsions directly following ECT.

  Monitored immediately after administration of ECT.

• Postictal supression

  Measures the degree of encephalographic supression directly following ECT

  Monitored immediately after administration of ECT.

• Need for restimulation

  Measures if there is a need for restimulation directly after evaluating the effect of an administered ECT.

  Monitored immediately after administration of ECT.

• Change in heart rate.

  Mesaures the increase in heart rate directly following ECT.

  Monitored immediately after administration of ECT.

Secondary Outcomes (10)

• Awareness

  Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.

• Adverse effects of ECT

  Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.

• Desaturation

  Monitored immediately before pre-oxygenation, during the entire ECT and until the patient has recovered. Approximately 1 hours of total monitoring time.

• End-tidal CO2

  During induction of general anesthesia

• Change in depressive symtoms

  Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.

Study Arms (1)

ECT-patients

Patients receiving routine ECT.

Device: Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA)

Interventions

Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA) DEVICE

The device monitors the patient's electroencephalogram using electrodes applied to the forehead.

ECT-patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted for ECT during the study period

You may qualify if:

• Admitted for a course of ECT

You may not qualify if:

• Not able to attach electrodes for measurement of depth of anesthesia due to eg. skin condition.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Universitetssjukhuset Örebro

Örebro, Bok 1613, 70116, Sweden

Location

Related Publications (8)

• UK ECT Review Group. Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis. Lancet. 2003 Mar 8;361(9360):799-808. doi: 10.1016/S0140-6736(03)12705-5.

  PMID: 12642045 BACKGROUND

• Minelli A, Abate M, Zampieri E, Gainelli G, Trabucchi L, Segala M, Sartori R, Gennarelli M, Conca A, Bortolomasi M. Seizure Adequacy Markers and the Prediction of Electroconvulsive Therapy Response. J ECT. 2016 Jun;32(2):88-92. doi: 10.1097/YCT.0000000000000274.

  PMID: 26397151 BACKGROUND

• Zolezzi M. Medication management during electroconvulsant therapy. Neuropsychiatr Dis Treat. 2016 Apr 19;12:931-9. doi: 10.2147/NDT.S100908. eCollection 2016.

  PMID: 27143894 BACKGROUND

• Kronsell A, Nordenskjold A, Bell M, Amin R, Mittendorfer-Rutz E, Tiger M. The effect of anaesthetic dose on response and remission in electroconvulsive therapy for major depressive disorder: nationwide register-based cohort study. BJPsych Open. 2021 Mar 23;7(2):e71. doi: 10.1192/bjo.2021.31.

  PMID: 33752777 BACKGROUND

• Guerrier G, Gianni MA. The effectiveness of BIS monitoring during electro-convulsive therapy: A systematic review and meta-analysis. J Clin Anesth. 2019 Dec;58:100-104. doi: 10.1016/j.jclinane.2019.05.006. Epub 2019 May 28.

  PMID: 31151038 BACKGROUND

• Li X, Cheng N, Deng Y, Du J, Zhang M, Guo Y, Hei Z. Incidence and risk factors for postictal delirium in patients after electroconvulsive therapy in China. Asian J Psychiatr. 2020 Oct;53:102361. doi: 10.1016/j.ajp.2020.102361. Epub 2020 Aug 25. No abstract available.

  PMID: 32890981 BACKGROUND

• Tsujii T, Uchida T, Suzuki T, Mimura M, Hirano J, Uchida H. Factors Associated With Delirium Following Electroconvulsive Therapy: A Systematic Review. J ECT. 2019 Dec;35(4):279-287. doi: 10.1097/YCT.0000000000000606.

  PMID: 31764452 BACKGROUND

• Eertmans W, De Deyne C, Genbrugge C, Marcus B, Bouneb S, Beran M, Fret T, Gutermann H, Boer W, Vander Laenen M, Heylen R, Mesotten D, Vanelderen P, Jans F. Association between postoperative delirium and postoperative cerebral oxygen desaturation in older patients after cardiac surgery. Br J Anaesth. 2020 Feb;124(2):146-153. doi: 10.1016/j.bja.2019.09.042. Epub 2019 Dec 18.

  PMID: 31862160 BACKGROUND

MeSH Terms

Conditions

Mood Disorders; Psychotic Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: April 1, 2022
• Study Start: April 19, 2022
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: March 30, 2023

Record last verified: 2022-02

Locations

SE (1)