Caudal Versus Intravenous Magnesium Sulfate In The Prevention OF Emergence Agitation After Sevoflurane Anesthesia For Lower Abdominal Surgeries In Children.
试验速览
- 阶段
- 不适用
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Number of Participants With sevoflurane-agitation are Assessed by Pediatric anesthesia emergency delirium scale (PAED) in 3 groups caudal versus intravenous magnesium sulfate infusions or caudal block alone
研究概览
简要总结
Sevoflurane is the agent of choice for induction and maintenance of day care anesthesia in children and has a wide acceptance among pediatric anesthesiologists.
Emergence agitation (EA) is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery, e.g. sevoflurane Magnesium sulfate is a non anesthetic N-methyl-D-aspartate receptor antagonist, Regional anesthetic techniques have major two benefits which are lowering anesthetic requirements intraoperatively and providing adequate postoperative pain relief.
Magnesium sulfate is an adjuvant that alters the perception and duration of pain by serving as an antagonist of N-methyl-D-aspartate glutamate receptors. Caudal injection of bupivacaine with magnesium sulfate in pediatric patients after inguinoscrotal operations provided adequate postoperative analgesia without producing many side effects. Caudal block with local anesthetic with or without adjuvants may prevent emergence agitation with effective postoperative pain management.
- So the aim of this study is to compare the efficacy of caudal versus intravenous magnesium sulfate infusions in controlling emergence agitations after inhalational sevoflurane anesthesia in children who will undergo lower abdominal surgeries.
Participants and methods
All participants will receive caudal block with bupivacaine 0.25% 1mg/kg dialed in 10 cm saline.
The participants will be divided to 3 groups
- Bupivacaine group (B group) (group 1) N = 31 :-
- Magnesium sulfate caudal group (MC group) (group 2) N = 31 :-
- Magnesium sulfate I.V group (MV group) (group 3) N = 31 :-
Postoperative assessment in the ( PACU):-
- The oxygen saturation (SO2), heart rate (HR), and mean arterial pressure (MAP) are monitored by the observer blinded to group allocation on admission and 10 mins till discharge (0, 10, 20, 30, 40, 50, 60mints, time of discharge) from the PACU.
- Emergence agitations (Pediatric anesthesia emergency delirium scale (PAED) The presence of Emergence agitation and its severity will be measured using (PAED).
The presence of Pain and its severity will be measured using FLACC scale.
- Time of first postoperative administration of fentanyl in mints
- Modified Aldrete score :- The discharge from the PACU will be measured using Modified Aldrete score.
详细描述
Participants and methods All participants will receive caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
The participants will be divided to 3 groups
- Bupivacaine group (B group) (group 1) N = 31 :- The participants will receive caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
- I.V injection of 10 cm saline over 10 mins then, followed by I.V infusion 50 cm saline with rate 10-20 ml/h according to child weight.
- Magnesium sulfate caudal group (MC group) (group 2) N = 31 :- The participants will receive caudal block with bupivacaine 0.25% 1mg/kg plus Magnesium sulfate 50 mg diluted in 10 cm saline.
- I.V injection of 10 cm saline over 10 mins then, followed by I.V infusion of 50 cm saline with rate 10-20 ml/h according to child weight.
- Magnesium sulfate I.V group (MV group) (group 3) N = 31 :- The participants will receive caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The group allocation is concealed in sealed, opaque envelopes, which are not opened until participant consent has been obtained. The participants, their anesthetists, and staff providing postoperative care are blinded to group assignment. The drugs are prepared in equal aliquots with code numbers. Closed envelop will be used
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants undergoing lower abdominal surgeries
排除标准
- •All participants with:-
- •history of developmental delay,
- •mental retardation,
- •psychological disorders or
- •Epilepsy which can make observational pain intensity assessment difficult,
- •a known or suspect coagulopathy,
- •a known allergy to any of the study drugs and
- •any signs of infection at the site of the proposed caudal block.
研究组 & 干预措施
Bupivacaine (B group)
caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
- I.V injection of 10 cm saline over 10 mins then, I.V infusion 50 cm saline with rate 10-20 ml/h according to child weight.
干预措施: Bupivacaine (Drug)
Magnesium sulfate caudal (MC group)
caudal block with bupivacaine 0.25% 1mg/kg + Magnesium sulfate 50 mg diluted in 10 cm saline.
- I.V injection of 10 cm saline over 10 mins then, I.V infusion of 50 cm saline with rate 10-20 ml/h according to child weight.
干预措施: Bupivacaine (Drug)
Magnesium sulfate caudal (MC group)
caudal block with bupivacaine 0.25% 1mg/kg + Magnesium sulfate 50 mg diluted in 10 cm saline.
- I.V injection of 10 cm saline over 10 mins then, I.V infusion of 50 cm saline with rate 10-20 ml/h according to child weight.
干预措施: Magnesium sulfate 50mg (Drug)
Magnesium sulfate I.V (M V group)
caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
- I.V injection of Magnesium sulfate 30mg/kg diluted in 10 cm saline over 10 mins then, I.V infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mg/kg/h.
干预措施: Bupivacaine (Drug)
Magnesium sulfate I.V (M V group)
caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
- I.V injection of Magnesium sulfate 30mg/kg diluted in 10 cm saline over 10 mins then, I.V infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mg/kg/h.
干预措施: Magnesium sulfate 30 mg (Drug)
结局指标
主要结局
Number of Participants With sevoflurane-agitation are Assessed by Pediatric anesthesia emergency delirium scale (PAED) in 3 groups caudal versus intravenous magnesium sulfate infusions or caudal block alone
时间窗: up to 96 weeks
(PAED). 1. The child makes eye contact with care giver 2. The child's actions are purposeful 3. The child is aware of his/her surroundings 4. The child is restless 5. The child is inconsolable * Items 1, 2 and 3 are scored: 4 = not at all, 3 = just a little, 2 quite a bit, 1 = very much, 0 = extremely. * Items 4 and 5 are scored: 0 = not at all, 1 = just a little, 2 = quite a bit, 3 = very much, 4 = extremely. * minimal score 0 maximal score 20 * It will be monitored on admission and every 10 mins till discharge from the PACU (0, 10, 20, 30, 40, 50, 60 mins, time of discharge). PAED score ≥ 10 fentanyl 1micg/kg I V will be given, repeated after 10 min if still agitated, with a maximum total dose of 2 micg/kg. (PAED) score ≥ 10 will be considered to be a diagnostic endpoint for agitation.
次要结局
- Number of Participants With Pain and its severity will be measured using FLACC in 3 groups caudal versus intravenous magnesium sulfate infusions or caudal block alone after inhalational sevoflurane anesthesia in children(up to 96 weeks)
- The discharge from the post anesthetic care unit will be measured using Modified Aldrete score after inhalational sevoflurane anesthesia in children in 3 groups(up to 96 weeks)
研究者
Marwa Ibrahim Abdo
Lecturer of anesthesia and surgical intensive care- principal investigator
Mansoura University