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Center for the Advancement of Perioperative Health® and the Departments of Anesthesiology, Pediatrics, and Child Psychiatry at Yale University School of Medicine, New Haven, CT and the Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon
Address correspondence and reprint requests to Zeev N. Kain, MD, MBA, Department of Anesthesiology, Yale University School of Medicine, 333 Cedar Street, New Haven, CT 06510. Address e-mail to kain{at}biomed.med.yale.edu.
| Abstract |
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| Introduction |
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| Methods |
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An investigator called the subjects the night before surgery, obtained initial consent, and asked each subject to bring a favorite CD to the hospital. The patients were also told that they may or may not have the opportunity to listen to the CD. Substitution was provided for patients without access to a CD. On the morning of surgery, demographic data were obtained, baseline sedation was assessed using the observational Observers Assessment of Alertness/Sedation Scale (OAA/S) (5), and baseline anxiety was assessed via self-report with the State-Trait Anxiety inventory (STAI) (6). A validated, reliable, Arabic version of the STAI was used for Lebanese subjects (Psychological Assessment Resources, Inc, Odessa, FL).
The research team consisted of a nonblinded member who randomized participants and administered the intervention and a blinded member who assessed outcomes only. The principal investigator led the investigation in both countries and the same protocol was applied in both sites. Patients were randomized into three groups. Ambient OR noise was controlled for via occlusive headphones in each group as follows:
After randomization and before surgery, the nonblinded researcher placed the CD player in an opaque box specially constructed to assure the blindness of the outcome assessor and connected the occlusive headphones. After administration of a spinal anesthetic and confirmation of an adequate dermatomal level of anesthesia, subjects received an IV dose of 1 µg/kg fentanyl citrate and 0.5 mg/kg propofol over 5 min. A sedation pump (Bard Ambulatory PCA, North Reading, MA) set to deliver 30 mg of propofol as often as every 5 min was connected to all patients.
Next, the nonblinded researcher placed the occlusive headphones and the assigned intervention was delivered. Vital signs (arterial blood pressure [BP], heart rate [HR], Spo2), propofol consumption, and OAA/S score were documented every 5 min by the blinded researcher. An external power switch was connected to the opaque box and power was temporarily turned off before each OAA/S was determined to assure blindness of the outcomes assessor. Duration of postanesthesia care unit (PACU) length of stay was also recorded.
The primary end-point of this study was propofol requirements in the various study groups. Sample size was computed a priori for the three groups using analysis of variance estimates.1 A previous investigation by our laboratory indicated that intraoperative propofol requirements for patients undergoing urological procedures under spinal anesthesia is approximately 1.6 ± 0.4 mg/min (1). Assuming a moderate/large effect size of 0.45 and a two-tailed
of 0.05, 30 participants in each of the 3 groups would yield power of about 0.90, sufficient to identify group differences. One-way analysis of variance with Scheffé post hoc analysis was used for continuous analyses and
2 for categorical analysis. Comparisons were considered significant if P < 0.05.
| Results |
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Next, we compared Yale New Haven Hospital data (n = 36) to American University of Beirut Medical Center data (n = 54). We found that, regardless of group assignment, patients at American University of Beirut Medical Center used less propofol as compared with patients at Yale New Haven Hospital (0.005 ± 0.001 mg · kg1 · min1 versus 0.017 ± 0.003; P = 0.001). Patients in the music group required less propofol at both centers (Table 2).
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The range of OAA scores was 14 during the surgical procedure and there were no group differences (P = not significant). No patient in this study experienced a critical respiratory event (defined as Spo2<90%) and all values of HR and BP were within normal limits. Finally, PACU times did not differ among groups (98 ± 45 min versus 110 ± 56 min versus 119 ± 64 min; P = not significant).
| Discussion |
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Although two previous investigations report that intraoperative music decreases sedative requirements in patients undergoing regional anesthesia (1,2), it was unclear if this decrease was attributable to the music or to the elimination of ambient OR noise. Dropping a surgical instrument into a bowl in the OR can produce noise levels of up to 80 dB (very loud to uncomfortably loud). Moreover, because sound is measured on a logarithmic scale, sudden noise as little as 30 dB above background noise may cause an immediate startle response with sympathetic activation (8). Thus, although decreases in sensory input during surgery may result in decreased sedative requirements, the results of the current study indicate that there is no such effect and that merely blocking the sensory overload of the OR with the use of white noise does not decrease sedative requirements. However, although previous studies show that ORs are noisy (3,4), in this study there was no measurement of ambient OR noise nor was there a patient assessment of the OR noise and environment. This is a clear limitation of the current study.
Previously, Cruise et al. (7) randomized patients to hear relaxing suggestions, white noise, OR noise, or relaxing music via headphones. The investigators found no differences in anxiety levels among groups at any time. Differences were noted in systolic BP but not in other vital signs. However, patients were more satisfied with their experience if they heard relaxing music rather than relaxing suggestions, white noise, or OR noise.
Of particular interest is our finding that Lebanese patients required less propofol than did American patients. An article examining anesthetic requirements of two different ethnic groups found that African blacks recovered more slowly from propofol than did Caucasians (9). The relationship between recovery time and overall propofol requirements remains unclear, and further investigation into this issue is warranted.
In conclusion, we have found that intraoperative music decreases sedative requirements in patients who undergo surgery under spinal anesthesia while controlling for OR ambient noise.
| Footnotes |
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Supported, in part, by the National Institutes of Health grants NICHD, R01HD3700702 (to Dr. Kain).
Accepted for publication November 23, 2004.
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This article has been cited by other articles:
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J. MacLaren and Z. N. Kain A Comparison of Preoperative Anxiety in Female Patients with Mothers of Children Undergoing Surgery Anesth. Analg., March 1, 2008; 106(3): 810 - 813. [Abstract] [Full Text] [PDF] |
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