| Methods |
Design: three group parallel trial
Purpose: examine the relationship between quality of sleep the night before surgery and several biochemical cerebro‐spinal fluid indicators |
| Participants |
Patients: in‐patients in need of surgery
Baseline comparability: yes (age, sex, weight, height) |
| Interventions |
Placebo: tablet with no midazolam or temazepam
Untreated: no tablet
Experimental:
‐tablet with midazolam
‐tablet with temazepam
(Co‐intervention: no) |
| Outcomes |
Quality of sleep
Concentrations of 3,4‐dihydroxyphenylglycol,
3‐methoxy‐4‐hydroxyphenylglycol, 3,4‐dihydroxyphenylacetic acid, homovanillic acid, tryptophan, 5‐hydroxyindoleacetic acid and cortisol |
| Notes |
Relevant outcome data not accessible: data lost (personal communication Irjala J) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'... the anaesthetist (J.I.) was not aware of the groupings' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
Relevant outcome data not accessible: data lost (personal communication Irjala J) |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 35 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
