Pediatric Anesthesia ISSN 1155-5645
ORIGINAL ARTICLE
The effects of bispectral index monitoring on hemodynamics and recovery profile in developmentally delayed pediatric patients undergoing dental surgery Mehmet Sargin, Mehmet Selcuk Uluer & Sadık Ozmen The Clinic of Anesthesiology and Reanimation, Konya Training and Research Hospital, Konya, Turkey
What is already known
• Potential beneficial effects of BIS monitorization on recovery profile are known both in children and in adults. However, no information related to this topic in developmentally delayed children is present.
What this article adds
• BIS guided anesthesia reduced recovery times after dental surgery in children with developmental delay. Implications for translation
• Routine BIS monitoring may be beneficial due to its favorable effects on the recovery profile in developmentally delayed pediatric patients.
Keywords bispectral index monitoring; hemodynamics; recovery profile; developmentally delayed pediatric patients; dental surgery Correspondence Mehmet Sargin, MD, The Clinic of Anesthesiology and Reanimation, Konya Training and Research Hospital, 42090 Konya, Turkey Email: [email protected] Section Editor: Andrew Davidson Accepted 14 April 2015 doi:10.1111/pan.12692
950
Summary Background: General anesthesia is often preferred for dental surgery or rehabilitation in developmentally delayed pediatric patients. Bispectral index monitoring is used to monitor the depth of anesthesia and to ensure early recovery. However, studies on the topic in developmentally delayed pediatric patients are limited. Aim: To evaluate the effects of Bispectral Index Scale (BIS) on hemodynamics and recovery profile in developmentally delayed pediatric patients undergoing dental surgery. Methods: Forty children between the ages of 6–16 years were studied in this prospective and randomized study. The children were randomized into two groups. In Group 1 (n = 20), general anesthesia was maintained with 1–2 minimum alveolar concentration (MAC) of sevoflurane in oxygen by standard practice. In Group 2 (n = 20), the depth of anesthesia was monitored by BIS. BIS values were continuously recorded from awake status to tracheal extubation. The duration of the surgical procedure, anesthesia, postanesthesia care unit (PACU) stay was noted. To evaluate recovery profile, time to spontaneous ventilation, extubation, open eyes, and PACU discharge were also noted. Results: There were significant differences between recovery times and Noncommunicating Children’s Pain Checklist – Postoperative Version (NCCPCPV) scores of two groups. Time to spontaneous ventilation [Difference in means (95% CI); 3.17 (1.79–4.54) P < 0.001], extubation [Difference in means (95% CI); 3.13 (1.66–4.60) P < 0.001], open eyes [Difference in means (95% CI); 3.97 (2.34–5.59) P < 0.001], and PACU stay time [Difference in means (95% CI); 23.55 (18.08–29.01) P < 0.001] were significantly shorter in Group 2. © 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 950–955
M. Sargin et al.
BIS monitoring in developmentally delayed pediatric patients
Conclusion: In conclusion, results suggest that routine BIS monitoring may be beneficial due to its favorable effects on the recovery profile in developmentally delayed pediatric patients.
Introduction General anesthesia is often preferred in developmentally delayed pediatric patients when undergoing dental rehabilitation or surgery due to the lack of cooperation. The most significant problem associated with general anesthesia is the determination and monitoring of the depth of anesthesia, for which the Bispectral Index Scale (BIS) has been used widely. The BIS is displayed number between 0 and 100, with 45–65 being suitable for surgical anesthesia. Bispectral Index Scale monitoring is used not only to prevent intraoperative awakening or awareness but also to provide an accurate titration of the anesthesia agents to promote faster recovery from anesthesia (1–4). Many clinical studies have shown that the administration of anesthetic agents under the guidance of BIS monitoring has allowed for more effective drug use, faster recovery from anesthesia, shorter time to extubation, and better recovery (5,6). There is however a lack of evidence for effectiveness sin children that are departmentally delayed. There are few, if any, clinical studies on the use of BIS in the pediatric population and in developmentally delayed pediatric patients, and although number of studies of pediatric patients in this regard is increasing, there is still paucity of publications regarding the BIS monitoring of developmentally delayed pediatric patients. We evaluated the effects of BIS monitoring on the recovery profile in developmentally delayed pediatric patients undergoing dental surgery in this prospective, randomized, and controlled trial. Materials and methods Institutional ethics committee approval and written consent from the legal guardian of each patient were obtained for the study. The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12614000890639). Forty children between the ages of 6–16 year, ASA physical status I, II and III, scheduled to undergo dental rehabilitation under general anesthesia, were studied in this prospective and randomized study. Patients with moderate (7) developmental delay were enrolled in this study. The extent of developmental delay in all patients was obtained from the previous medical reports given by pediatric neurologists working in state hospitals. © 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 950–955
The children were randomized, by using a computergenerated block randomization, into two groups. In Group 1 (control) (n = 20), BIS monitoring was not performed, and general anesthesia was maintained with 1–2 MAC of sevoflurane in oxygen by standard practice. In Group 2 (BIS directed) (n = 20), the depth of anesthesia was monitored by the BIS (BIS VISTA, Aspect Medical) and BIS scores were maintained between 45 and 65 by titrated sevoflurane. All patients were expected to fast 6–8 h before dental surgery, and no one was premedicated. Routine monitors (consisting of a pulse oximeter, 3-lead ECG, and a non-invasive blood pressure cuff, and BIS monitoring only Group 2) were applied. Baseline measurements were obtained and 3 min of preoxygenation was performed before the induction of general anesthesia. In both groups, general anesthetic management consisted of face mask inhalation induction with sevoflurane 8% in oxygen and then intravenous (i.v.) catheter was placed. Intravenous rocuronium 0.6 mgkg 1 was given to facilitate tracheal intubation. After making sure that all four TOF responses of the adductor pollicis disappeared, intubation (with an appropriately sized nasotracheal tube) was then performed. After induction, volume controlled mechanical ventilation [tidal volume adjusted to 6–8 mlkg 1 with no application of positive end expiratory pressure and respiratory rates were adjusted to achieve an endtidal carbon dioxide (ETCO2) of 30–35 mm Hg.] was initiated. Anesthesia was maintained using sevoflurane in an oxygen ⁄ air mixture and remifentanil (0.25 lgkg 1min 1). When mean blood pressure (MBP) varied by more than 20% from the baseline, the infusion rate of crystalloid solution was increased. If this was not sufficient, the inspired anesthetic concentration was reduced and anesthesia was maintained in this way in Group 1. In Group 2, anesthesia was maintained by BIS scores between 45 and 65. Paracetamol (10 mgkg 1) were given i.v. to attenuate postoperative pain. While BIS score, heart rate (HR), MBP, oxygen saturation (SpO2), ETCO2, and TOF values were monitored continuously, they were recorded at the following times; basal, after induction, after intubation, at the start of surgery, every 10 min during surgery, at the end of surgery, after extubation, and during eye opening in response to verbal stimulus or painful pinching. Remifentanil infusion was stopped and all patients were weaned of sevoflurane as the surgery neared con951
M. Sargin et al.
BIS monitoring in developmentally delayed pediatric patients
clusion (when started control of bleeding). Hence, when the surgery ended, it coincided with the sevoflurane being turned off. Sugammadex (2 mgkg 1) was used for neuromuscular recovery in all patients when anesthesic agents were turned off. When neuromuscular recovery was completed and adequate depth of breathing was reached (after the return of adequate ventilator drive, tidal volume >6 mlkg 1, respiratory rate >12 per min, normal breathing patterns and good oxygenation [SpO2 > 98%]) tracheal extubation was done. Following tracheal extubation, patients were cared for in the postanesthesia care unit (PACU). In the PACU, the criteria for discharge (which included consciousness, normal vital signs, no pain, and no nausea or vomiting) were the same for all patients. All patients discharged from the PACU according to the customary guidelines practiced in the institution. Discharge from PACU decision was given by an anesthesiologist blinded to groups. For measuring pain, Non-communicating Children’s Pain Checklist – Postoperative Version (NCCPC-PV) (8) was used in PACU. The NCCPC-PV was designed to be used for children, aged 3–18 years, who are unable to speak because of cognitive (mental/ intellectual/developmentally) impairments or disabilities. The NCCPC-PV was designed to be used without training by parents and caregivers, or by other adults who are not familiar with a specific child. NCCPC-PV consists of seven chapters (vocal, social, facial, activity, body and limbs, physiological). A total score of 11 or more indicates a child has moderate to severe pain. And a total score of 6–10 indicates a child has mild pain. The pain scores of patients were assessed with 10-min intervals while patients stayed in PACU, and maximum NCCPC-PV score was recorded. A total Score of 7 or more indicates a child has pain and a nonsteroidal anti-inflammatory drug were given i.v. to attenuate pain. The duration of the surgical procedure, anesthesia (time of induction to time of discontinuation of anesthetic agents), and PACU stay was noted. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), extubation (the time between anesthetic discontinuation and extubation), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching), and PACU discharge was also noted. Our study was designed to have a 90% power at the 95% significance level to detect a 50% decrease in the time to extubation when the BIS monitoring used as reported by Messieha et al. (9). On the basis of a preliminary study evaluating time to extubation, we calcu952
lated that 16 patients for each groups and total 40 patients were required. Statistical analyses were performed with SPSS 15.0 software (SPSS Institute, Chicago, IL, USA). Parametric data were tested with Student’s t test and presented as means and standard deviation, as means and standard error of the means, accordingly. Categorical data were analyzed with the two-tailed Pearson’s v2 test and are given as numbers. A P-value
ORIGINAL ARTICLE
The effects of bispectral index monitoring on hemodynamics and recovery profile in developmentally delayed pediatric patients undergoing dental surgery Mehmet Sargin, Mehmet Selcuk Uluer & Sadık Ozmen The Clinic of Anesthesiology and Reanimation, Konya Training and Research Hospital, Konya, Turkey
What is already known
• Potential beneficial effects of BIS monitorization on recovery profile are known both in children and in adults. However, no information related to this topic in developmentally delayed children is present.
What this article adds
• BIS guided anesthesia reduced recovery times after dental surgery in children with developmental delay. Implications for translation
• Routine BIS monitoring may be beneficial due to its favorable effects on the recovery profile in developmentally delayed pediatric patients.
Keywords bispectral index monitoring; hemodynamics; recovery profile; developmentally delayed pediatric patients; dental surgery Correspondence Mehmet Sargin, MD, The Clinic of Anesthesiology and Reanimation, Konya Training and Research Hospital, 42090 Konya, Turkey Email: [email protected] Section Editor: Andrew Davidson Accepted 14 April 2015 doi:10.1111/pan.12692
950
Summary Background: General anesthesia is often preferred for dental surgery or rehabilitation in developmentally delayed pediatric patients. Bispectral index monitoring is used to monitor the depth of anesthesia and to ensure early recovery. However, studies on the topic in developmentally delayed pediatric patients are limited. Aim: To evaluate the effects of Bispectral Index Scale (BIS) on hemodynamics and recovery profile in developmentally delayed pediatric patients undergoing dental surgery. Methods: Forty children between the ages of 6–16 years were studied in this prospective and randomized study. The children were randomized into two groups. In Group 1 (n = 20), general anesthesia was maintained with 1–2 minimum alveolar concentration (MAC) of sevoflurane in oxygen by standard practice. In Group 2 (n = 20), the depth of anesthesia was monitored by BIS. BIS values were continuously recorded from awake status to tracheal extubation. The duration of the surgical procedure, anesthesia, postanesthesia care unit (PACU) stay was noted. To evaluate recovery profile, time to spontaneous ventilation, extubation, open eyes, and PACU discharge were also noted. Results: There were significant differences between recovery times and Noncommunicating Children’s Pain Checklist – Postoperative Version (NCCPCPV) scores of two groups. Time to spontaneous ventilation [Difference in means (95% CI); 3.17 (1.79–4.54) P < 0.001], extubation [Difference in means (95% CI); 3.13 (1.66–4.60) P < 0.001], open eyes [Difference in means (95% CI); 3.97 (2.34–5.59) P < 0.001], and PACU stay time [Difference in means (95% CI); 23.55 (18.08–29.01) P < 0.001] were significantly shorter in Group 2. © 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 950–955
M. Sargin et al.
BIS monitoring in developmentally delayed pediatric patients
Conclusion: In conclusion, results suggest that routine BIS monitoring may be beneficial due to its favorable effects on the recovery profile in developmentally delayed pediatric patients.
Introduction General anesthesia is often preferred in developmentally delayed pediatric patients when undergoing dental rehabilitation or surgery due to the lack of cooperation. The most significant problem associated with general anesthesia is the determination and monitoring of the depth of anesthesia, for which the Bispectral Index Scale (BIS) has been used widely. The BIS is displayed number between 0 and 100, with 45–65 being suitable for surgical anesthesia. Bispectral Index Scale monitoring is used not only to prevent intraoperative awakening or awareness but also to provide an accurate titration of the anesthesia agents to promote faster recovery from anesthesia (1–4). Many clinical studies have shown that the administration of anesthetic agents under the guidance of BIS monitoring has allowed for more effective drug use, faster recovery from anesthesia, shorter time to extubation, and better recovery (5,6). There is however a lack of evidence for effectiveness sin children that are departmentally delayed. There are few, if any, clinical studies on the use of BIS in the pediatric population and in developmentally delayed pediatric patients, and although number of studies of pediatric patients in this regard is increasing, there is still paucity of publications regarding the BIS monitoring of developmentally delayed pediatric patients. We evaluated the effects of BIS monitoring on the recovery profile in developmentally delayed pediatric patients undergoing dental surgery in this prospective, randomized, and controlled trial. Materials and methods Institutional ethics committee approval and written consent from the legal guardian of each patient were obtained for the study. The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12614000890639). Forty children between the ages of 6–16 year, ASA physical status I, II and III, scheduled to undergo dental rehabilitation under general anesthesia, were studied in this prospective and randomized study. Patients with moderate (7) developmental delay were enrolled in this study. The extent of developmental delay in all patients was obtained from the previous medical reports given by pediatric neurologists working in state hospitals. © 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 950–955
The children were randomized, by using a computergenerated block randomization, into two groups. In Group 1 (control) (n = 20), BIS monitoring was not performed, and general anesthesia was maintained with 1–2 MAC of sevoflurane in oxygen by standard practice. In Group 2 (BIS directed) (n = 20), the depth of anesthesia was monitored by the BIS (BIS VISTA, Aspect Medical) and BIS scores were maintained between 45 and 65 by titrated sevoflurane. All patients were expected to fast 6–8 h before dental surgery, and no one was premedicated. Routine monitors (consisting of a pulse oximeter, 3-lead ECG, and a non-invasive blood pressure cuff, and BIS monitoring only Group 2) were applied. Baseline measurements were obtained and 3 min of preoxygenation was performed before the induction of general anesthesia. In both groups, general anesthetic management consisted of face mask inhalation induction with sevoflurane 8% in oxygen and then intravenous (i.v.) catheter was placed. Intravenous rocuronium 0.6 mgkg 1 was given to facilitate tracheal intubation. After making sure that all four TOF responses of the adductor pollicis disappeared, intubation (with an appropriately sized nasotracheal tube) was then performed. After induction, volume controlled mechanical ventilation [tidal volume adjusted to 6–8 mlkg 1 with no application of positive end expiratory pressure and respiratory rates were adjusted to achieve an endtidal carbon dioxide (ETCO2) of 30–35 mm Hg.] was initiated. Anesthesia was maintained using sevoflurane in an oxygen ⁄ air mixture and remifentanil (0.25 lgkg 1min 1). When mean blood pressure (MBP) varied by more than 20% from the baseline, the infusion rate of crystalloid solution was increased. If this was not sufficient, the inspired anesthetic concentration was reduced and anesthesia was maintained in this way in Group 1. In Group 2, anesthesia was maintained by BIS scores between 45 and 65. Paracetamol (10 mgkg 1) were given i.v. to attenuate postoperative pain. While BIS score, heart rate (HR), MBP, oxygen saturation (SpO2), ETCO2, and TOF values were monitored continuously, they were recorded at the following times; basal, after induction, after intubation, at the start of surgery, every 10 min during surgery, at the end of surgery, after extubation, and during eye opening in response to verbal stimulus or painful pinching. Remifentanil infusion was stopped and all patients were weaned of sevoflurane as the surgery neared con951
M. Sargin et al.
BIS monitoring in developmentally delayed pediatric patients
clusion (when started control of bleeding). Hence, when the surgery ended, it coincided with the sevoflurane being turned off. Sugammadex (2 mgkg 1) was used for neuromuscular recovery in all patients when anesthesic agents were turned off. When neuromuscular recovery was completed and adequate depth of breathing was reached (after the return of adequate ventilator drive, tidal volume >6 mlkg 1, respiratory rate >12 per min, normal breathing patterns and good oxygenation [SpO2 > 98%]) tracheal extubation was done. Following tracheal extubation, patients were cared for in the postanesthesia care unit (PACU). In the PACU, the criteria for discharge (which included consciousness, normal vital signs, no pain, and no nausea or vomiting) were the same for all patients. All patients discharged from the PACU according to the customary guidelines practiced in the institution. Discharge from PACU decision was given by an anesthesiologist blinded to groups. For measuring pain, Non-communicating Children’s Pain Checklist – Postoperative Version (NCCPC-PV) (8) was used in PACU. The NCCPC-PV was designed to be used for children, aged 3–18 years, who are unable to speak because of cognitive (mental/ intellectual/developmentally) impairments or disabilities. The NCCPC-PV was designed to be used without training by parents and caregivers, or by other adults who are not familiar with a specific child. NCCPC-PV consists of seven chapters (vocal, social, facial, activity, body and limbs, physiological). A total score of 11 or more indicates a child has moderate to severe pain. And a total score of 6–10 indicates a child has mild pain. The pain scores of patients were assessed with 10-min intervals while patients stayed in PACU, and maximum NCCPC-PV score was recorded. A total Score of 7 or more indicates a child has pain and a nonsteroidal anti-inflammatory drug were given i.v. to attenuate pain. The duration of the surgical procedure, anesthesia (time of induction to time of discontinuation of anesthetic agents), and PACU stay was noted. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), extubation (the time between anesthetic discontinuation and extubation), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching), and PACU discharge was also noted. Our study was designed to have a 90% power at the 95% significance level to detect a 50% decrease in the time to extubation when the BIS monitoring used as reported by Messieha et al. (9). On the basis of a preliminary study evaluating time to extubation, we calcu952
lated that 16 patients for each groups and total 40 patients were required. Statistical analyses were performed with SPSS 15.0 software (SPSS Institute, Chicago, IL, USA). Parametric data were tested with Student’s t test and presented as means and standard deviation, as means and standard error of the means, accordingly. Categorical data were analyzed with the two-tailed Pearson’s v2 test and are given as numbers. A P-value
