Clinical trial NCT05308056: Depth of Anesthesia During Electroconvulsive Therapy
Official title: Depth of Anetshesia During Electroconvulsive Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mood Disorders
Psychotic Disorders
Keywords: General anesthesia
Electroencephalogram
Awareness
Depth of anesthesia
Depression
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted for ECT during the study period

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.

Detailed description: Background Electroconvulsive therapy (ECT) is an effective therapy for severe depression where an electric current is applied to the brain to induce an epileptic seizure (1). The success of ECT is dependent upon the degree and quality of epileptic activity (2). ECT is normally administered after administering a muscle relaxant to prevent the seizure activity from causing muculoskeletal injuries. To tolerate the muscle relaxant the entire procedure is performed under general anesthesia. Most hypnotics have anti-convulsant effects and therefore counteract the effects of ECT (3). This implies that deep anesthesia hinders an optimal treatment effect of ECT which is supported by observational data (4). This relation has been proven with lighter anesthesia measured through bispectral index (BIS) correlating to longer seizure duration (5). BIS is not optimized to estimate the depth of anesthesia under very dynamic anesthetic protocols as there is an inherent latency in the computation of the BIS value. Anesthesia for ECT generally consists only of induction and recovery with no stable anesthetic phase making BIS an inappropriate measure of anesthetic depth. Indices of anesthetic depth that are derived directly from the processed EEG-signal have a negligent latency and can therefore be used with more precision during anesthesia for ECT. Spectral edge frequency (SEF) is the frequency under which 95 % of the total amplitude of the EEG-signal is found and it decreases with increasing depths of anesthesia. The density spectral array (DSA) is a graphic representation of the frequency and amplitude of the EEG signal over time and it is possible to interpret the DSA in real time without extensive training. The SEF and DSA have not, to our knowledge, been previously tested during general anesthesia for ECT. In the postictal phase during recovery from ECT some patients become agitated and confused (6). This condition is not clearly defined in the literature but is commonly referred to as postictal agitation (PIA) and due to differing definitions the incidence is difficult to estimate. Incidences in the range of 10-20 % have been reported (7). In the post-operative period after cardiac surgery decreased regional cerebral oxygen saturation (SrcO2) has been linked to post-operative confusion (8). A possible link between decreased SrcO2 and PIA has not been studied before.

Aim

The aim of this research project is two-fold:

1. To study the relation between anesthetic depth measured with SEF and DSA and the quality of epileptic activity during ECT.
2. To study the relation between SrcO2 and PIA during ECT.

Hypotheses

1. Lighter depths of anesthesia as measured by SEF and DSA have a positive correlation with epileptic seizure quality during ECT.
2. SrcO2 during ECT has an inverse correlation with the incidence of PIA. Method Setting and recruitment The study will be performed at the ECT-unit of the university hospital in Örebro. General anesthesia is provided by a nurse specially trained in anesthesia and an anesthesiologist. ECT is provided by specially trained nurses and staff at the ECT-unit. Patients recover from the postictal phase in an adjacent recovery room. Patients undergoing ECT through the outpatient clinic will be recruited to the study.

Anesthetic protocol The protocol for anesthesia and ECT will be the same as is being used clinically at the ECT-unit. After preoxygenation anesthesia is induced using thiopental. After confirmation of adequate anesthetic depth (failure to respond to verbal command) suxamethonium is administered. Doses are chosen by the anesthesiologist. Patients are admitted to the recovery room when breathing spontaneously and can maintain a patent airway.

Data collection SEF and DSA will be measured continuously from before pre-oxygenation to admittance to the recovery room using a SedLine® (Masimo, Irvine, CA, USA) monitor. The monitor will be blinded during the procedure so as not to affect the staff in any way. SrcO2 will be measured using the same monitor during the same period. Data regarding the seizure duration will be gathered from the electronic patient records. The staff caring for the postictal patients will estimate the degree of PIA according to previously used numerical scale (9).Data will be presented as mean ± SD or median (IQR) according to their distribution. Statistical analysis will be performed using a logistic regression model adjusted for potential confounders such as type of psychiatric medication, age, bilateral or unilateral stimulation.

Eligibility criteria: Inclusion Criteria:

* Admitted for a course of ECT

Exclusion Criteria:

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

Primary outcomes:
measure: Change in spectral edge frequency
timeFrame: Monitored before, during and after ECT. Total monitoring time is apporximately 30 minutes per patient.
measure: Change in density spectral array
timeFrame: Monitored before, during and after ECT. Total monitoring time is approximately 30 minutes per patient.
measure: Duration of convulsive activity
timeFrame: Monitored immediately after administration of ECT.
measure: Postictal supression
timeFrame: Monitored immediately after administration of ECT.
measure: Need for restimulation
timeFrame: Monitored immediately after administration of ECT.
measure: Change in heart rate.
timeFrame: Monitored immediately after administration of ECT.
Secondary outcomes:
measure: Awareness
timeFrame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.
measure: Adverse effects of ECT
timeFrame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.
measure: Desaturation
timeFrame: Monitored immediately before pre-oxygenation, during the entire ECT and until the patient has recovered. Approximately 1 hours of total monitoring time.
measure: End-tidal CO2
timeFrame: During induction of general anesthesia
measure: Change in depressive symtoms
timeFrame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
measure: Clinical assessment of depth of anesthesia
timeFrame: Monitored immediately before pre-oxygenation, during the entire ECT and until the patient leaves the recovery ward. Approximately 1 hour of total monitoring time.
measure: Regional cerebral oxygen saturation
timeFrame: Before, during and after anesthesia and ECT
measure: Occurence of post-ictal agitation
timeFrame: Monitored in the recovery suite
measure: Change in quality of life
timeFrame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
measure: Change in illness severity
timeFrame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
state: Bok 1613
Study officials:
References:
citation: 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.
citation: 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.
citation: Zolezzi M. Medication management during electroconvulsant therapy. Neuropsychiatr Dis Treat. 2016 Apr 19;12:931-9. doi: 10.2147/NDT.S100908. eCollection 2016.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.