Anesthesia Clinical Trial
Official title:
The Effect of Intraoperative Music Listening on Sevoflurane Consumption and Recovery Parameters
NCT number | NCT02220452 |
Other study ID # | Sofia-Music |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | December 2024 |
- The perioperative period can be a significant source of psychological burden, anxiety and fear for patients - Both pharmacological and non-pharmacological methods have been proposed in order to alleviate perioperative stress - Music is one of the non-pharmacological methods which have been used in this context, with favorable effects both preoperatively and postoperatively - The attenuation of perioperative stress through music listening is probably due to the activation of emotional and cognitive processes that evoke feeling of pleasure and can distract patients' attention from fear and unpleasant thoughts related to the surgical procedure - Little information is available regarding the effect of intraoperative music listening on anesthetized, unconscious patients - There is a notion that general anesthesia does not completely abolish auditory perception and that some processing of intraoperative events can occur in unconscious patients, even in the absence of postoperative recall - The investigators hypothesis is that intraoperative music listening can decrease anesthetic requirements and reduce sevoflurane consumption in female patients subjected to abdominal hysterectomy for benign disease.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective hysterectomy for benign disease Exclusion Criteria: - hearing impairment - psychiatric disease (depression, dementia) - mental disability - concurrent treatment with medication known to affect anesthetic requirement, such as benzodiazepines, anticonvulsants, opioids, psychotropic drugs or alcohol |
Country | Name | City | State |
---|---|---|---|
Greece | Aretaieion University Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Aretaieion University Hospital |
Greece,
Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Human learning during general anaesthesia and surgery. Br J Anaesth. 1991 Feb;66(2):170-8. doi: 10.1093/bja/66.2.170. — View Citation
Bringman H, Giesecke K, Thorne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009 Jul;53(6):759-64. doi: 10.1111/j.1399-6576.2009.01969.x. Epub 2009 Apr 14. — View Citation
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Ganidagli S, Cengiz M, Yanik M, Becerik C, Unal B. The effect of music on preoperative sedation and the bispectral index. Anesth Analg. 2005 Jul;101(1):103-6, table of contents. doi: 10.1213/01.ANE.0000150606.78987.3B. — View Citation
Lindh A, Carlstrom K, Eklund J, Wilking N. Serum steroids and prolactin during and after major surgical trauma. Acta Anaesthesiol Scand. 1992 Feb;36(2):119-24. doi: 10.1111/j.1399-6576.1992.tb03436.x. — View Citation
Wang SM, Kulkarni L, Dolev J, Kain ZN. Music and preoperative anxiety: a randomized, controlled study. Anesth Analg. 2002 Jun;94(6):1489-94, table of contents. doi: 10.1097/00000539-200206000-00021. — View Citation
Zhang XW, Fan Y, Manyande A, Tian YK, Yin P. Effects of music on target-controlled infusion of propofol requirements during combined spinal-epidural anaesthesia. Anaesthesia. 2005 Oct;60(10):990-4. doi: 10.1111/j.1365-2044.2005.04299.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | sleep diary | a questionnaire will be used to assess the specific outcome measure and participants will be queried in the first postoperative morning | first postoperative night | |
Other | sleep diary | a questionnaire will be used to assess the specific outcome measure and participants will be queried in the second postoperative morning | second postoperative night | |
Primary | sevoflurane consumption during general anesthesia | the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined | change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours | |
Secondary | recall of postoperative events | a questionnaire will be used to assess the specific outcome measure | participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour | |
Secondary | recall of postoperative sounds | a questionnaire will be used to assess the specific outcome measure | participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour | |
Secondary | occurence of postoperative nausea or vomiting | a questionnaire will be used to assess the specific outcome measure | participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour | |
Secondary | intensity of postoperative pain | a verbal rating scale will be used to assess the specific outcome measure | participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour | |
Secondary | satisfaction from anesthesia | a verbal rating scale will be used to assess the specific outcome measure | participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour | |
Secondary | measurement of prolactin levels | during the time that patients are anesthetized, an approximate period of 2 hours |
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