To study the effect of two different amount of clear liquid ingestion on total volume of stomach, its emptying time (rate of clearing of fluid from stomach) and remaining volume (residual volume) in children undergoing elective surgery
- Conditions
- Other symptoms and signs concerning food and fluid intake,
- Registration Number
- CTRI/2019/02/017425
- Lead Sponsor
- AIIMS Jodhpur
- Brief Summary
*Background:* Perioperative pulmonary aspirationrisk increases with increased preoperative gastric volume; hence traditionally,patients are kept fasted overnight before surgery. Current guidelines recommend2-hours clear fluids fasting prior to anaesthesia. However, emerging evidencefavours allowing 3 mL/kg clear fluids up to 1-hour before anaesthesia. Wecompared the gastric volume and gastric emptying time after ingestion of 3mL/kg and 5 mL/kg of clear fluids.
*Methods:* Forty-four children were enrolledafter getting informed and written consent from parents. On the day of surgery,baseline gastric volume was estimated using ultrasound and patients wererandomly allocated in to two groups of equal number i.e. Group 3 and Group 5(patients received 3 mL/kg and 5 mL/kg 5% Dextrose respectively). Repeatedgastric ultrasound was done at every five-minutes interval until the gastricvolume reached at baseline. The primary objective of the study was to comparegastric volume and gastric emptying time while secondary objectives wereoccurrence of PONV, occurrence of irritability and parent’s satisfaction.
*Results:* The demographic profile,preoperative fasting duration and baseline gastric volume was comparablebetween groups. In both groups, compared to baseline the gastric volumeincreased significantly following fluid ingestion and then decreased exponentiallyto reach at baseline within 1-hour. The median (IQR) gastric emptying time andemptying t1/2 (minutes) in group 3 was 35.0 (28.75, 40.0) and 17.00(15.73, 21.50) respectively while in group 5 it was 40.0 (28.75, 45.0) and18.55 (15.98, 21.98) respectively (p=0.16 and p=0.44 respectively). The occurrence of nausea, vomiting andirritability as well as parent satisfaction were comparable between the groups(p>0.05).
*Conclusion:* As the gastric volume returned tobaseline within 1-hour even after ingesting 5mL/kg clear fluids, the preoperative fasting time can be reduced to 1-hour and childrencan be safely allowed to drink up to 5 mL/kg clear fluids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 44
belonging to ASA physical status class I or II, fasted as per guidelines and scheduled for elective surgery.
Children with gastrointestinal disease (gastro oesophageal reflux, hiatus hernia, or gastritis), presence of any major co-existing medical illness or congenital disorder, undergoing emergency surgery, violation of the prescribed fasting times, and refusing to drink prescribed clear fluid according to the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare time taken for the gastric volume to return at baseline after ingestion of two different quantities (3 and 5 ml/kg) of clear liquid and thereby to determine gastric emptying time and residual gastric volume. To compare time taken for the gastric volume to return at baseline after ingestion of two different quantities (3 and 5 ml/kg) of clear liquid and thereby to determine gastric emptying time and residual gastric volume.
- Secondary Outcome Measures
Name Time Method To compare incidence of nausea and vomiting. To compare incidence of irritability.
Trial Locations
- Locations (1)
AIIMS, Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
AIIMS, Jodhpur🇮🇳Jodhpur, RAJASTHAN, IndiaDr Sadik MohammedPrincipal investigator9414849733drmsadik@gmail.com