Toshiyuki Hijikata1, Takahiro Mihara, Nobuhito Nakamura, Takaaki Miwa, Koui Ka, Takahisa Goto. 1. From the Department of Anaesthesiology, Itabashi Chuo Medical Centre (TH); Department of Anaesthesiology, Kanagawa Children's Medical Centre (TH, TM, NN, TM, KK); and Department of Anaesthesiology and Critical Care Medicine, Yokohama City University Graduate School of Medicine (TM, KK, TG).
Abstract
BACKGROUND: Emergence agitation is common in children recovering from general anaesthesia. The prevention of emergence agitation remains an important challenge in the field of paediatric anaesthesia. OBJECTIVE: We aimed to examine the effectiveness of electrically stimulating the heart 7 (HT7) acupuncture site with a peripheral nerve stimulator (PNS) during surgery, for preventing emergence agitation in paediatric patients recovering from general anaesthesia. DESIGN: A double-blind, randomised, controlled, parallel-group trial. SETTING:Kanagawa Children's Medical Centre, Yokohama, Japan. PATIENTS: One hundred and twenty patients aged 18 to 96 months (American Society of Anesthesiologists physical status I or II) undergoing minor elective surgery under general anaesthesia withsevoflurane. INTERVENTION: Patients were randomly assigned to either undergo bilateral stimulation of HT7 with two PNS devices (1 Hz, 50 mA) during surgery (Group HT7) or a control group that did not undergo electrical stimulation of HT7 during surgery. MAIN OUTCOME MEASURES: The primary outcome was the incidence of emergence agitation evaluated in the postanaesthesia care unit (PACU) using the Paediatric Anaesthesia Emergence Delirium scale. The secondary outcomes were the time from operation completion to tracheal extubation, PACU stay duration and postoperative pain scores. RESULTS: The incidence of emergence agitation was significantly lower in the HT7 group compared with the control group (31.7 vs. 56.7%, respectively; P = 0.010). The risk ratio was 0.56 (95% confidence interval 0.36 to 0.86) and the number needed to treat was 4 (95% confidence interval 3 to 13). There were no statistically significant differences between groups in time from operation completion to tracheal extubation, PACU stay duration or postoperative pain. CONCLUSION: Bilateral electrical stimulation of HT7 using two PNS devices significantly decreases the incidence of emergence agitation. TRIAL REGISTRATION: UMIN Clinical Trial Registry (registry number: UMIN000011704).
RCT Entities:
BACKGROUND:Emergence agitation is common in children recovering from general anaesthesia. The prevention of emergence agitation remains an important challenge in the field of paediatric anaesthesia. OBJECTIVE: We aimed to examine the effectiveness of electrically stimulating the heart 7 (HT7) acupuncture site with a peripheral nerve stimulator (PNS) during surgery, for preventing emergence agitation in paediatric patients recovering from general anaesthesia. DESIGN: A double-blind, randomised, controlled, parallel-group trial. SETTING: Kanagawa Children's Medical Centre, Yokohama, Japan. PATIENTS: One hundred and twenty patients aged 18 to 96 months (American Society of Anesthesiologists physical status I or II) undergoing minor elective surgery under general anaesthesia with sevoflurane. INTERVENTION: Patients were randomly assigned to either undergo bilateral stimulation of HT7 with two PNS devices (1 Hz, 50 mA) during surgery (Group HT7) or a control group that did not undergo electrical stimulation of HT7 during surgery. MAIN OUTCOME MEASURES: The primary outcome was the incidence of emergence agitation evaluated in the postanaesthesia care unit (PACU) using the Paediatric Anaesthesia Emergence Delirium scale. The secondary outcomes were the time from operation completion to tracheal extubation, PACU stay duration and postoperative pain scores. RESULTS: The incidence of emergence agitation was significantly lower in the HT7 group compared with the control group (31.7 vs. 56.7%, respectively; P = 0.010). The risk ratio was 0.56 (95% confidence interval 0.36 to 0.86) and the number needed to treat was 4 (95% confidence interval 3 to 13). There were no statistically significant differences between groups in time from operation completion to tracheal extubation, PACU stay duration or postoperative pain. CONCLUSION: Bilateral electrical stimulation of HT7 using two PNS devices significantly decreases the incidence of emergence agitation. TRIAL REGISTRATION: UMIN Clinical Trial Registry (registry number: UMIN000011704).