| 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 |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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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 |
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Scientific Title of Study
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Evaluation of the effects of a preoperative carbohydrate drink on postoperative vomiting in paediatric strabismus surgery: a randomised controlled observer blinded trial |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
|
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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 |
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institue of Medical Sciences, New Delhi |
Approved |
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Regulatory Clearance Status from DCGI
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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, |
|
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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 |
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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.
|
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| 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. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Outcome Assessor Blinded |
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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 |
|
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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. |
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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" |
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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 |
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Publication Details
|
None |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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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:
- 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.
- Hill LT, Miller MGA. Carbohydrate loading in the preoperative setting. S Afr Med J 2015; 105:173–4.
- Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg . 2017;152:292–8.
- 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.
- 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.
- 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.
- Apfelbaum JL, Caplan RA, Connis RT, Epstein BS, Nickinovich DG, Warner 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.
- 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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