An observational study in Mood Disorders and Psychotic Disorders, sponsored by Region Örebro County. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Region Örebro County · Observational
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.
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:
Hypotheses
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.
595 studies on the registry are indexed under Mood Disorders; 119 are open to participants now.
This study's enrollment of 37 is below the median of 180 across 147 observational studies indexed under Mood Disorders.
Browse Mood Disorders studies →Region Örebro County is the lead sponsor of 124 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients admitted for ECT during the study period
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients receiving routine ECT.
Device: Depth of anesthesia monitor, SedLine® (Masimo, Irvine, CA, USA)
The device monitors the patient's electroencephalogram using electrodes applied to the forehead.
Change in spectral edge frequency
The spectral edge frequency of the patients electroencephalogram
Time frame: 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
Time frame: 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.
Time frame: Monitored immediately after administration of ECT.
Postictal supression
Measures the degree of encephalographic supression directly following ECT
Time frame: 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.
Time frame: Monitored immediately after administration of ECT.
Change in heart rate.
Mesaures the increase in heart rate directly following ECT.
Time frame: Monitored immediately after administration of ECT.
Awareness
Patients will be asked if they can recall any part of the tratment from induction of anesthesia until administration of ECT.
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.
Adverse effects of ECT
Occurence of adverse effects following ECT, evaluated using the CRPS-memory questionnaire.
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s.
Desaturation
Occurence of saturation \<92 % at any point during anesthesia and ECT.
Time frame: 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
Measurement of end-tidal CO2
Time frame: During induction of general anesthesia
Change in depressive symtoms
Effect of ECT on patients' symptoms and quality of life. Evaluated using the self-asessed Montgomery Åsberg Depression Rating Scale (MADRS-S), 0-57 points. A higher score indicate more severe disease.
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Clinical assessment of depth of anesthesia
The treating anesthesiologist will be asked to asses the depth of anesthesia. The anesthesiologist is asked after induction of general anesthesia. The terms too heavily sedated, too lightly sedated and adequate level of sedation is used.
Time frame: Monitored immediately before pre-oxygenation, during the entire ECT and until the patient leaves the recovery ward. Approximately 1 hour of total monitoring time.
Regional cerebral oxygen saturation
Measured using near-infrared spectroscopy
Time frame: Before, during and after anesthesia and ECT
Occurence of post-ictal agitation
Registered in the recovery ward following ECT. A scale using three levels of agitation is used by the recovery staff. Higher scores indicate increasing levels of agitation.
Time frame: Monitored in the recovery suite
Change in quality of life
Effect of ECT on patients' symptoms and quality of life. Evaluated using EruroQol 5-Dimensions score (EQ-5D), each quiestion is scored 1-3 or 1-5 points. A higher score indicates worse health related problems.
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Change in illness severity
Effect of ECT on patients' symptoms and quality of life. Evaluated using Clinial global impressions scale (CGI), each question is scored 1-7 points. A higher score indicates higher illness severity.
Time frame: Patients are asked at a follow up visit approximately 1 week after a course of several ECT:s and before ECT.
Plan to share: Undecided
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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