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CTRI Number  CTRI/2018/01/011361 [Registered on: 16/01/2018] Trial Registered Prospectively
Last Modified On: 31/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare effect of giving carbohydrate containing drink 2 hours before surgery as compared to sips of plain water till 2 hour prior to surgery in children undergoing squint surgery 
Scientific Title of Study   Evaluation of the effects of a preoperative carbohydrate drink on postoperative vomiting in paediatric strabismus surgery: a randomised controlled observer blinded trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjolie Chhabra 
Designation  Professor Anaesthesiology 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 5013, 5th floor, Teaching block, AIIMS, New Delhi
Ansari Nagar, New Delhi
Central
DELHI
110029
India 
Phone  9810104383  
Fax  01126588641  
Email  anjolie5@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhavana Karayat 
Designation  Junior Resident Anaesthesiology  
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 5011, 5th floor, Teaching block, AIIMS, New Delhi
Ansari Nagar, New Delhi
Central
DELHI
110029
India 
Phone  01126593212  
Fax  01126588641  
Email  bhavanakayarat27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anjolie Chhabra 
Designation  Professor Anaesthesiology 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 5013, 5th floor, Teaching block, AIIMS, New Delhi
Ansari Nagar, New Delhi
Central
DELHI
110029
India 
Phone  9810104383  
Fax  01126588641  
Email  anjolie5@hotmail.com  
 
Source of Monetary or Material Support
Modification(s)  
All India Institute of Medical Sciences, Ansari nagar, New Delhi 
Fujifilm Sonsite India Private Limited 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Indian Council of Medical Research  V. Ramalingaswami Bhawan, Ansari Nagar, Postbox-4911, New Delhi-110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjolie Chhabra  Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi  OT Complex and Wards, Dr Rajendra Prasad Centre for Ophthalmic Sciences, Ansari Nagar, AIIMS, New Delhi
Central
DELHI 
00919810104383
01126588641
anjolie5@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institue of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Children aged 5-15 years old scheduled to undergo strabismus surgery on 2 or more muscles under general anaesthesia, (1) ICD-10 Condition: H509||Unspecified strabismus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1   Group 1 will be asked to ingest 10 ml/kg of 12.5 % maltodextrin containing carbohydrate drink 2 hours prior to surgery. 
Comparator Agent  Group 2  Group 2 will be given 10ml/kg of water and instructed to take sips of water as and when the child desires over a period of time from 12 midnight upto 2 hours prior to surgery. If a child desires more water in the prescribed time it will be provided. Any water remaining in the bottle or extra water consumed will be measured so as to determine the volume of water ingested by the child upto 2 hours prior to surgery 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  To evaluate postoperative nausea and vomiting in the first 24 hours following strabismus (squint) surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Gastric antral volume   2 hours after ingestion of fluid 
Preoperative anxiety in the preoperative area   Prior to surgery 
Time to awakening (achieving Aldrete score 9/10)  After stopping propofol total intravenous anaesthesia. 
Postoperative anxiety after surgery after the patient is fully awake in the post anaesthesia care unit (PACU)  After surgery, once patient is fully awake. 
Time to re-feeding after surgery  in the postoperative period. 
Post operative pain in the first 24 hours.  0-2 hours, 2-6 hours, 6-24 hours. 
Perioperative insulin resistance  Prior to surgery and immediately after surgery. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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.
 
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