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

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClicnicalTrials.gov, ID: NCT02955680. Registered on 2 November 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2164-4) contains supplementary material, which is available to authorized users.