A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients

Forced-air warming, midazolam or control prevention of anxiety as measured by a 100-mm visual analog scale in patients presenting for elective non-cardiac surgery.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000272392

Enrollment

120

Registered

2008-05-29

Start date

2008-08-07

Completion date

2009-04-03

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We tested the hypothesis that pre-operative forced-air warming is as effective for anxiolysis as intravenous midazolam, using a blinded, placebo controlled factorial design. One hundred and twenty patients were randomly assigned to cotton blanket and saline injection (n = 30), forced-air warmer and saline injection (n = 30), midazolam 30 lg.kg)1 and cotton blanket (n = 30), and forced-air warmer and midazolam 30 lg.kg)1 (n = 30). Patients completed visual analogue scales for anxiety and thermal comfort, and the State-Trait Anxiety Inventory, at baseline and after 20 min. The estimated effect of midazolam on visual analogue scores for anxiety was )10 (95% CI )3 to )18; p = 0.007) and on state anxiety was )5 (95% CI )7 to )4; p = 0.03). Warming had no influence on visual analogue scores for anxiety (p = 0.50) or state anxiety (p = 0.33), but its estimated effect on thermal comfort was +23 (95% CI 19–27; p < 0.0001). There was no interaction between midazolam and warming. Pre-operative warming was not equivalent to midazolam for anxiolysis and cannot be recommended solely for this purpose.

Interventions

Reassurance, cotton blanket, saline injection (2 ml at time 0); Reassurance, cotton blanket, midazolam injection (0.3 mg/kg i.v. at time 0); Reassurance, forced-air warming blanket, midazolam injection (0.3 mg/kg at time 0). Reassurance and cotton blanket or forced air warming blanket applied from time 0 to time 20. Study conducted in the 20 minutes prior to induction of anaesthesia.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Patients aged between 18 and 70 years, male and female Presenting for elective surgery Requiring general anaesthesia American Society of Anesthesiologists' physical status score 1-3

Exclusion criteria

Cardiothoracic and intracranial surgery Day case surgery Pre-existing anxiety disorder Patients on psychotropic drugs preoperatively Febrile patients T > 37.5 degrees Celsius Allergy to midazolam Obstructive Sleep Apnoea diagnosed on sleep study

Outcome results