Comparison of the effects of inhalational anaesthetics and total intravenous anaesthesia on the incidence of emergence delirium in paediatric surgeries less than 3 hours duration
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To compare the incidence of Emergence Delirium between inhalational and intravenous anaesthestics given as maintenance of anaesthesia using PAED scale
研究概览
简要总结
The use of inhalational agents as maintenance is widely practiced in the world. Meanwhile the use of TIVA is also the best choice in paediatric anaesthesia. So it is always a debate for inhalational or tiva in management. Emergence agitation is the important issue in paediatric anaesthesia especially with inhalational agents. It may precipitate maladaptive behaviour, memory impairment also.Considering the pharmacological action of propofol, TIVA can be a good alternative in this. The ideal anaesthetic should be the one with rapid emergence and short stay in PACU without any side effects. The factors contributing to emergence delirium are multifactorial including age,perioperative anxiety,pain,personal character of patient,type of surgery,rapid awakening, and the anaesthetic agent used4 . Emergence delirium leads to increased chances of wound dehiscence ,damage to surgical repair,bleeding,pulling out of drain,iv access , physical self harm to child, delayed recovery and prolonged hospital stay. This behaviour is often difficult to manage by the caregivers and needs constant supervision and leads to parental dissatisfaction 5. Once emergence delirium has occurred ,it increases the recovery time in PACU,predisposes their parents or caregivers to anxiety and stress Chandler et al7 showed a lower incidence of ED after total intravenous anesthesia (TIVA) than that after SEVO anesthesia in children aged 2–6 years following strabismus surgery. Most studies shows the children with TIVA has shown reduced incidence of emergence agitation when compared to inhalational agents. In inhalational agent, sevoflurane has higher incidence than isoflurane. But the role of sevoflurane is needed as it is the induction agent of choice for pediatrics in whom securing iv line is not possible for intravenous induction as well as slow and irritant odour inhalataional agent isoflurane is also not practically used when the child is awake. In our routine practice in the institution, sevoflurane for induction and isoflurane for maintenance of anaesthesia is used.So the use of total intravenous anaesthesia in maintenance is not clearly studied yet in pediatric surgeries. Our study aims to compare the quality of recovery in terms of incidence of emergence delirium with the usage of inhalational agent-isoflurane and total intravenous anaesthesia with propofol in children undergoing surgical procedures with duration less than 3 hours.
All the children with ASA 1-2 with age group of 2 to 12 years who are undergoing surgeries – GI,genitourinary,limb surgeries with duration less than 3 hours will be recruited. Informed consent who fulfill the inclusion criteria will be obtained for participation in the study before the procedure. In the operating room standard ASA(American society of anaesthesiologists) monitors will be established – Spo2,ECG,NIBP,ETCO2,and bispectral index (BIS)monitor. Sealed envelopes are used for allocation with two groups. Group A will have isoflurane as maintenance and group B will have propofol for maintenance of anaesthesia. This is randomized controlled trial. The investigator will be blinded to the allocation. Both groups will have endotracheal intubation after administration with atracurium(0.5 mg/kg) and ventilated with tidal volume of 6-8 ml/kg. The endtidal carbondioxide is maintained between 30 and 35 by adjusting respiratory rate and tidal volume.
Group A (isoflurane group) In inhalational group, Mask induction was performed with mixture of N2O and O2 for 60 s followed by incremental increases in inspired sevoflurane. Following loss of consciousness, an intravenous line was established, fentanyl 0.5 mg/kg is given and then maintained with inhalational agent- isoflurane with its MAC will be maintained less than 0.9 .
Group B (TIVA group) In TIVA group Mask induction was performed with mixture of N2O and O2 for 60 s followed by incremental increases in inspired sevoflurane . Following loss of consciousness, an intravenous line was established, fentanyl 0.5mg/kg is given and then maintained with propofol infusion 100 – 250 mcg/kg/hr administered to achieve appropriate depth of anaesthesia indicated by BIS score of 40 to 60.
Once all the procedures were completed, the patients were extubated and transferred to the postanesthesia care unit (PACU). The data regarding post operative outcomes will be recorded by the recovery nurse who will be blinded to the anaesthetic methods. Quality of recovery,postoperative pain, postoperative nausea vomiting, and extubation time will be taken into record. The extubation time will be calculated as the time from the end of anesthesia to extubation of the nasotracheal tube. In the PACU,the time taken till the child shows appropriate response is noted. Also the patients will be evaluated at10 min intervals using the Aldrete scale. The Aldrete scoring system is used to clinically evaluate the physical status of patients recovering from general anesthesia. A score of 0–2 is given for each of the five categories (activity, circulation, consciousness, O2 saturation, and respiration) with a maximum score of 10. Recovery time will be calculated from the patient’s arrival to the PACU to the achievement of an Aldrete score of more than or equal to 9. The Pediatric Anesthesia Emergence Delirium (PAED) scale will be used to assess patients on the following five psychometric items: 1. the child makes eye contact with the caregiver; 2. the child’s actions are purposeful; 3. the child is aware of his or her surroundings; 4. the child is restless; and 5. the child is inconsolable. Items 1–3 are reversed scored as follows: 4-not at all; 3-just a little,2-quite a bit,1-very much,and 0-extremely. Items 4 and 5 are scored as follows- 0-not at all, 1-just a little,2-quite a bit,3-very much,and 4-extremely. The scores of each item are summed to obtain a total PAED score.2 ED increases directly with the total score. A PAED score of more than10 will signify the presence of emergence delirium. The Face, Legs, Activity, Cry, Consolability (FLACC) scale will be used to assess the postoperative pain. Responses in each category will be scored between 0 and 2, for a maximum total score of 10. A pain score is obtained by reviewing the descriptions of behavior in each of the FLACC categories and selecting the number that most closely matches the observed behavior. The numbers obtained for each category are added to obtain the total pain score, which will be between 0 and 10.10 Observational scoring was performed immediately after the patient was sufficiently alert to make purposeful movements. The same blinded nurse will monitor the children for 40 min in the PACU. The PAED and FLACC scores will be evaluated every 10 min during the observation period, and the highest scores will be recorded for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients undergoing elective Genitourinary, Gastrointestinal, Limb surgeries with less than 3 hours duration.
- •ASA physical status I, II.
排除标准
- •Patient refusal ASA physical status III or more Age less than 2 years and more than 12 years History of allergic to anaesthetic drugs.
结局指标
主要结局
To compare the incidence of Emergence Delirium between inhalational and intravenous anaesthestics given as maintenance of anaesthesia using PAED scale
时间窗: 2 hours
次要结局
- To compare the incidence of Nausea and Vomiting among two grups(To compare post operative Analgesia among two groups)
研究者
Jeno Shelton V
Christian Medical College Vellore
