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Effect of a mother’s recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial

Overview of attention for article published in Trials, September 2017
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Title
Effect of a mother’s recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial
Published in
Trials, September 2017
DOI 10.1186/s13063-017-2164-4
Pubmed ID
Authors

Seok Young Song, Sang Gyu Kwak, Eugene Kim

Abstract

Emergence delirium is a behavioral disturbance after general anesthesia in children and may distress both the patients and the primary caregivers, such as parents and medical staff, looking after the patients. Various medical and emotional interventions have been investigated to reduce emergence delirium; however, none are completely effective. This trial intends to assess whether the mother's recorded voice can reduce this adverse post-anesthesia event and facilitate arousal from general anesthesia. This is a prospective, double-blind, single-center, parallel-arm, superiority, randomized controlled trial to be conducted in participants aged 2-8 years who are undergoing elective surgery requiring general anesthesia. Participants will be randomly assigned to one of two groups: those who are stimulated to wake up by listening to their mother's recorded voice (maternal group, n = 33) or a stranger's voice (stranger group, n = 33) during anesthetic emergence. The primary outcome is the initial emergence delirium score in the post-anesthesia care unit (PACU). The secondary outcomes are hemodynamic parameters, including heart rate and mean blood pressure, the duration of time between the cessation of anesthetics and a BIS level of 60, 70 and 80, eye-opening or purposeful movement time, extubation time, total consumption of analgesics, PACU stay time, emergence delirium and pain scores during the PACU stay. This is the first randomized controlled trial to investigate the effect of a mother's recorded voice during emergence on the pediatric emergence profile after general anesthesia. It may provide prophylactic treatment options to decrease emergence delirium and enhance arousal from general anesthesia. ClicnicalTrials.gov, ID: NCT02955680 . Registered on 2 November 2016.

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Geographical breakdown

Country Count As %
Unknown 118 100%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 15 13%
Student > Master 15 13%
Student > Bachelor 13 11%
Student > Doctoral Student 6 5%
Researcher 4 3%
Other 14 12%
Unknown 51 43%
Readers by discipline Count As %
Medicine and Dentistry 23 19%
Nursing and Health Professions 15 13%
Psychology 9 8%
Neuroscience 5 4%
Unspecified 3 3%
Other 10 8%
Unknown 53 45%