Understanding How Anaesthesia Affects ECT Outcomes

NCT03105245 | Completed Phase 3

• 1 other identifier: HREC16952
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine how anaesthetic technique affects ECT outcomes. Specifically, the investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus, and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a recording of brain activity during ECT and is used to judge the quality of a seizure and to guide individual patient dosing).

Conditions

Depression

Keywords

electroconvulsive therapy; anaesthesia

Outcome Measures

Primary Outcomes (1)

• EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al

  EEG quality will be rated manually for each ECT treatment undertaken by a participant until the conclusion of their ECT course. This rating will be done using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al - low dose lignocaine added to propofol does not attenuate the response to electroconvulsive therapy; Journal of Affective Disorders, 2010; 126: 330-333

  Outcome measures will be collected immediately after each ECT treatment from the first treatment until the end of the ECT course, an estimated total of four to six weeks for most participants

Study Arms (4)

Short time interval + Normal ventilation

ACTIVE COMPARATOR

Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Short time interval + Hyperventilation

ACTIVE COMPARATOR

Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Long time interval + Normal ventilation

ACTIVE COMPARATOR

Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Long time interval + Hyperventilation

ACTIVE COMPARATOR

Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)

Interventions

Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) OTHER

The intervention in this study is the time interval between anaesthetic administration and ECT stimulus

Long time interval + Hyperventilation; Long time interval + Normal ventilation; Short time interval + Hyperventilation; Short time interval + Normal ventilation

Eligibility Criteria

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

You may qualify if:

• Patients treated with a course of ECT

You may not qualify if:

• Use of non-standard anaesthetic agents in ECT (e.g. ketamine)

Sponsors & Collaborators

• The University of New South Wales: lead
• Wesley Mission: collaborator

Study Sites (1)

Wesley Hospital Kogarah

Sydney, New South Wales, 2217, Australia

Location

MeSH Terms

Conditions

Depression

Interventions

Electroconvulsive Therapy; Anesthetics; Thiopental

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Colleen Loo, MBBS

  The University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and the outcome assessor (analysing EEGs) will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Each participant will receive all four treatment conditions in randomly allocated sequence during their ECT course. That is, participants will receive either short or long anaesthetic-ECT stimulus time interval treatments, and normal or hyperventilation treatments - this results in four possible combinations, which individual participants will cycle through in random order during their ECT course (e.g. short-hyperventilation, long-normal ventilation, short-normal ventilation, long-hyperventilation).

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: April 7, 2017
• Study Start: March 15, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)