Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy
Randomised, double-blind, parallel-group Phase IV trial (n=60) comparing adjunctive IV ketamine 0.5 mg/kg versus saline combined with sevoflurane induction during ECT in patients with major depression.
Detailed Description
Parallel-group randomised trial comparing sevoflurane induction plus a single IV bolus of ketamine 0.5 mg/kg versus sevoflurane plus saline during ECT; groups described as Group SK and Group SS.
Primary measurements include motor and EEG seizure durations and haemodynamic responses (MAP and HR) recorded at baseline, post-induction, and at 0, 1, 3 and 10 minutes after seizure end.
Study Arms & Interventions
Sevoflurane + Ketamine
experimentalSevoflurane induction (8% until loss of consciousness) followed by IV ketamine 0.5 mg/kg bolus (Group SK; n≈29).
Interventions
- Ketamine0.5 mg/kgvia IV• single dose
IV bolus 0.5 mg/kg given after induction
- Placebovia Inhalation• single dose
Sevoflurane 8% for induction until loss of consciousness, then discontinued
Sevoflurane + Saline
inactiveSevoflurane induction (8% until loss of consciousness) followed by IV saline placebo bolus (Group SS; n≈30).
Interventions
- Placebovia Inhalation• single dose
Sevoflurane 8% for induction until loss of consciousness, then discontinued
- Placebovia IV• single dose
Isotonic saline IV bolus as placebo
Participants
Inclusion Criteria
- Inclusion Criteria:
- Major depressive patients
Exclusion Criteria
- Exclusion Criteria:
- Pregnancy
- Have a history of myocardial infarction in the previous six months
- Atrial fibrillation or flutter
- Heart block
- Unregulated hypertension
- Cerebrovascular diseases
- A known drug allergy
Study Details
- StatusUnknown status
- PhasePhase IV
- Typeinterventional
- DesignRandomizeddouble Blind
- Target Enrollment60 participants
- TimelineStart: 2014-07-01End: 2014-10-01
- Compounds
- Topic