Effects of Opipramol as an Evening Anaesthesiologic Premedication

Abstract

To date, opipramol has not been examined within the context of evening premedication in anaesthesiology. A suitable drug for such an application should induce anxiolytic and sleep-favouring effects. Due to its pharmacological properties, one would expect opipramol to lead to these effects. In order to test this possibility, 72 female patients were randomly assigned to 50 mg opipramol, 100 mg opipramol, or placebo (n = 24 patients per group) in the evening prior to surgery in a double-blind trial. Effects were recorded in the morning prior to the operation by means of self-rating questionnaires, regarding the patients’ current subjective state and their judgement of the quality of sleep during the night before. The self-rating was done by the Multidimensional Mood Inventory BSKE (EWL), by use of the Multidimensional Somatic Symptom List (MSKL), and by use of the Würzburg Sleep Questionnaire. Further dependent variables were heart rate and blood pressure. Opipramol significantly improved sleep quality. Especially the frequency of awakening at night was reduced. These effects could be observed predominantly after 100 mg opipramol. At this dosage, inner excitement was reduced as well. The autonomic variables remained uninfluenced. There were no adverse events and no hints for interactions with anaesthesiology.

Opipramol Improves Subjective Quality of Sleep the Night Prior to Surgery: Confirmatory Testing of a Double-Blind, Randomized Clinical Trial

“…All items are rated on 5-point scales. The reliability of this scale is considered good (Cronbach's ␣ = 0.82-0.86) [4] . The items 'time till falling asleep', 'feelings when lying awake at night' and 'feeling fit in the morning' were analyzed as single items.…”

“…To record the current somatic state, the Multidimensional Somatic Symptom List (MKSL) by Erdmann and Janke [28] was implemented. All self-rating methods proved to be reliable in describing the somatic and psychic state prior to surgery and are described in detail in earlier publications [4,29,30] .…”

“…Calculation of sample size depends on results of Gerlach et al [4] who found that 100 mg opipramol improves quality of sleep with an effect size of d = 0.51. We assumed the effect would be stronger at a dose of 150 mg opipramol.…”

“…Improvement of sleep quality may be regarded as an aim of premedication [4] . Restful pre-operative sleep the night before surgery is linked to autonomic stabilization on the patient [5] .…”

“…In a randomized placebo-controlled trial, Gerlach et al [4] applied 50 mg opipramol or 100 mg opipramol to patients in the evening prior to surgery. Effects were recorded in the morning prior to the operation by means of self-rating questionnaires, regarding the patients' current subjective state and their judgement of the quality of sleep during the night before.…”