BackgroundEmergence 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/designThis 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.DiscussionThis 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 registrationClicnicalTrials.gov, ID: NCT02955680. Registered on 2 November 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2164-4) contains supplementary material, which is available to authorized users.

BackgroundSore throat is common after tracheal intubation. Water can be used to lubricate tracheal tubes, but its benefit has not been validated. We thus did a randomised non-inferiority trial to test the hypothesis that a tube lubricated with water does not reduce sore throat after tracheal intubation.MethodsWe randomized female or male patients (n = 296) undergoing surgery in the ears or eyes to receive either a tube lubricated with water or a tube without lubrication for intubation. We assessed sore throat at 0, 2, 4, and 24 h after surgery; pharyngeal injury at 2 and 24 h after surgery; and respiratory infections within 7 days after surgery. For the incidence of sore throat within 24 h after surgery (primary outcome), the two-sided 90% confidence interval of the risk difference was compared with the prespecified non-inferiority margin of 15%. Other outcomes were analyzed with two-sided superiority tests.ResultsThe incidence of sore throat within 24 h after surgery was 80/147 (54.4%) in the non-lubricated tube group and 83/149 (55.7%) in the water-lubricated tube group (risk difference -1.3%, 90% confidence interval -10.9% to 8.3%). Because the confidence interval was below the non-inferiority margin, the incidence of sore throat was not higher in the non-lubricated tube group than in the water-lubricated tube group. There was no significant association between groups in the sore throat, pharyngeal injury, and respiratory infection at each assessment time.ConclusionsThe tube lubricated with water did not reduce sore throat and pharyngeal injury after tracheal intubation compared to the tube without lubrication.

BackgroundAccording to several studies investigating the relationship between muscle activity and electroencephalogram results, reversal of neuromuscular blockade (NMB) may affect depth of anesthesia indices. Therefore, we investigated the effect of pyridostigmine on these indices via spectral entropy.MethodsFifty-six patients scheduled for thyroidectomy or parotidectomy were included in this study and randomized into two groups. At the start of skin suturing, the desflurane concentration was adjusted to 4.2 vol% in both groups. Following this, the pyridostigmine group (group P, n = 28) was administered pyridostigmine 0.2 mg/kg mixed with glycopyrrolate 0.04 mg/kg, while the control group (group C, n = 28) received normal saline. Entropy values (response entropy [RE] and state entropy [SE]), train of four (TOF) ratio, and end-tidal desflurane concentration were recorded from point of drug administration to 15 minutes post-drug administration.ResultsMean RE values at 15 minutes, when the maximum effect of pyridostigmine was anticipated, showed a statistically significant difference between groups (53.8 ± 10.5 in group P and 48.0 ± 8.8 in group C; P = 0.030). However, mean SE at 15 minutes showed no significant difference between the two groups (P = 0.066). At 15 minutes, there were significant differences in the TOF ratio between the two groups (P < 0.001).ConclusionsNMB reversal by pyridostigmine significantly increased RE values but not SE values. This finding suggests that spectral entropy may be a useful alternative tool for monitoring anesthetic depth during recovery from anesthesia in the presence of electromyogram activity.

BackgroundWater is known to have lubricating properties, thus it is used for lubrication of tracheal tubes to reduce airway injuries caused by intubation. However, there is no definite evidence to substantiate the beneficial effects of lubricating tracheal tubes using water for attenuating airway injuries. Moreover, the lubrication pretreatment may cause contamination of the tube, leading to respiratory infections. Therefore, this trial aims to assess whether no pretreatment of tracheal tubes does not increase post-intubation airway complications as compared with water lubrication of tubes.Methods/designThis is a prospective, double-blind, single-center, parallel-arm, noninferiority, randomized controlled trial to be conducted in participants aged 20–80 years who are undergoing elective surgery under general anesthesia with orotracheal intubation. Participants are randomly assigned into one of two groups depending on whether intubation is performed using a tracheal tube lubricated with water (n = 150) or without any pretreatment (n = 150). The primary outcome is the incidence of sore throat at 0, 2, 4, and 24 h after surgery, which is analyzed with a noninferiority test. The secondary outcomes are the incidence and severity of postoperative hoarseness, oropharyngeal injuries, and respiratory infections.DiscussionBecause we hypothesized that lubricating tracheal tubes using water has no advantage in reducing airway injuries associated with intubation, we will compare the incidence of sore throat, which is the most common complaint after intubation, in a noninferiority manner. This is the first randomized controlled trial to investigate the possibly beneficial or harmful effects of lubricating tracheal tubes using water before intubation. We expect that this trial will provide useful evidence to formulate a protocol for preparing tracheal tubes before intubation.Trial registrationThis trial is registered at ClinicalTrials.gov on 1 July 2015 (NCT02492646)Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1699-0) contains supplementary material, which is available to authorized users.