跳至主要内容
临床试验/CTRI/2018/01/011361
CTRI/2018/01/011361招募中不适用

Evaluation of the effects of a preoperative carbohydrate drink on postoperative vomiting in paediatric strabismus surgery: a randomised controlled observer blinded trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年4月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
To evaluate the effects of a 10 ml/kg, 12.5% carbohydrate drink given 2 hours preoperatively on postoperative nausea and vomiting in the first 24 hours in patients undergoing paediatric strabismus surgery as compared to children taking sips of water upto 2 hours preoperatively

研究概览

简要总结

Postoperative nausea and vomiting (PONV) continues to be a major concern after paediatric strabismus surgery with the incidence ranging from 8.9% and 42%. It is defined as any episode of nausea, vomiting or retching during the first 24-hour period after surgery.(1)

The cause of PONV after strabismus surgery is complex and depends on several factors like patient characteristics, type of surgery, anaesthetic technique, postoperative pain and perioperative fluid therapy. In exploring more treatment options and with the idea to provide maximum perioperative satisfaction to the patients, the idea of a multimodal approach that included preoperative carbohydrate ingestion was considered.

The typical physiological response to surgery includes release of stress hormones and cytokines induced hyperglycemic and catabolic metabolic profile. The nutritional compromise due to fasting worsens this response. (2)

Preoperative carbohydrate loading is an integral part of the ERAS (Enhanced Recovery After Surgery) recommendation as part of the multimodal approach to reduce the patients’ length of stay and perioperative complications in patients undergoing colorectal surgery.(3)

One of the recommended methods of control of stress induced hyperglycemia and catabolic state is the provision of isotonic, carbohydrate containing clear fluids until 2 hours preoperatively so that the patients are in a metabolically fed state. The principle is the provision of an energy containing liquid meal that will result in insulin secretion necessary to alter the fasted metabolic state. (2)Carbohydrate loading will also reduce the preoperative thirst and hunger providing an overall subjective satisfaction and thereby reducing preoperative anxiety.

There is some evidence that administration of carbohydrates in the perioperative period reduces incidence of postoperative nausea and vomiting (PONV) in adults undergoing short surgical procedures such as laparoscopic cholecystectomy under general anaesthesia.(4-6)

Though literature supports administration of clear fluids to paediatric patients upto 2 hours prior to general anaesthesia, there is no clarity on whether carbohydrate loading with complex carbohydrates as recommended in the ERAS protocol would benefit paediatric patients undergoing surgery under GA, especially highly emetogenic surgeries such as strabismus surgery.(7, 8)

The surmise of the present study is that patients undergoing highly emetogenic strabismus surgery if given carbohydrate containing clear fluids orally as opposed to sips of non-carbohydrate containing clear fluids till 2 hours preoperatively, will be in a metabolically better fed state, resulting in less preoperative anxiety, faster awakening with lesser incidence of pain and PONV in the postoperative period.

The primary objective of this study will be to ascertain incidence of PONV in the first 24 hours after strabismus surgery in children getting oral preoperative carbohydrate (maltodextrin) containing fluid (10ml/kg or 1.25gm/kg maltodextrin) as compared to children being fasted and administered oral sips of clear water till 2 hours preoperatively which is what is usually done in our hospital.

References:

  1. Oh AY, Kim JH, Hwang JW, Do SH, Jeon YT. Incidence of postoperative nausea and vomiting after paediatric strabismus surgery with sevoflurane or remifentanil-sevoflurane. Br J Anaesth .2010 ;104:756–60.
  2. Hill LT, Miller MGA. Carbohydrate loading in the preoperative setting. S Afr Med J 2015; 105:173–4.
  3. Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg . 2017;152:292–8.
  4. Yilmaz N, Cekmen N, Bilgin F, Erten E, Ozhan MÖ, Coşar A. Preoperative carbohydrate nutrition reduces postoperative nausea and vomiting compared to preoperative fasting. J Res Med Sci . 2013;18:827–32.
  5. Hausel J, Nygren J, Thorell A, Lagerkranser M, Ljungqvist O. Randomized clinical trial of the effects of oral preoperative carbohydrates on postoperative nausea and vomiting after laparoscopic cholecystectomy. Br J Surg. 2005;92:415–21.
  6. Singh BN, Dahiya D, Bagaria D, Saini V, Kaman L, Kaje V, et al. Effects of preoperative carbohydrates drinks on immediate postoperative outcome after day care laparoscopic cholecystectomy. SurgEndosc. 2015;29:3267–72.
  7. Apfelbaum JLCaplan RAConnis RTEpstein BSNickinovich DGWarner MA. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures. Anesthesiology. 2011;114:495–511.
  8. Smith I, Kranke P, Murat I, Smith A, O’SullivanG, Soreide E, et al. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011; 28:556–69.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • 1.Paediatric patients of age 5-15 years sheduled to undergo strabismus surgery on two or more muscles under general anaesthesia.
  • 2.Patients should be of American Society of Anaesthesiologist physical status 1 or 2.

排除标准

  • 1.Children with Gastroesophageal reflux disease (GERD) 2.Children diagnosed with diabetes 3.Children with bulbar muscle involvement resulting in difficulty in swallowing 4.Children with cognitive impairment (clinical assessment)or impairment of verbal communication/speech.
  • 5.Children with a medical history of any psychiatric illness.
  • 6.Parent or child s refusal to participate in the study.

结局指标

主要结局

To evaluate the effects of a 10 ml/kg, 12.5% carbohydrate drink given 2 hours preoperatively on postoperative nausea and vomiting in the first 24 hours in patients undergoing paediatric strabismus surgery as compared to children taking sips of water upto 2 hours preoperatively

时间窗: To evaluate postoperative nausea and vomiting in the first 24 hours following strabismus (squint) surgery

次要结局

  • Postoperative anxiety after surgery after the patient is fully awake in the post anaesthesia care unit (PACU)(After surgery, once patient is fully awake.)
  • Gastric antral volume(2 hours after ingestion of fluid)
  • Time to awakening (achieving Aldrete score 9/10)(After stopping propofol total intravenous anaesthesia.)
  • Preoperative anxiety in the preoperative area(Prior to surgery)
  • Time to re-feeding after surgery(in the postoperative period.)
  • Perioperative insulin resistance(Prior to surgery and immediately after surgery.)
  • Post operative pain in the first 24 hours.(0-2 hours, 2-6 hours, 6-24 hours.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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