An interventional study of Maltodextrin carbohydrate drink and Sugar water in Respiratory Aspiration, Hyperglycemia and Inflammation, sponsored by Udayana University. Recruiting at 1 site in Indonesia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Udayana University · Not applicable, Interventional, and Supportive care
Before surgery, patients are asked to fast so the stomach is empty and stomach contents cannot enter the lungs during anesthesia. Long fasting is uncomfortable and can raise blood sugar and stress responses in older adults. Giving a carbohydrate drink up to 2 hours before surgery is part of enhanced recovery (ERAS) programs. It is not clear whether a maltodextrin drink or sugar water leaves less fluid in the stomach of older patients.
This randomized, double-blind study enrolls patients aged 60 years and older who are having elective lower limb orthopedic surgery under spinal or epidural anesthesia at Prof. Ngoerah General Hospital in Denpasar, Indonesia. Participants are assigned by chance to drink 400 mL of either a maltodextrin carbohydrate drink or sugar water 2 hours before anesthesia. The amount of fluid in the stomach is measured with bedside ultrasound before the drink and 2 hours after it. Blood glucose is measured before the drink, 2 hours after it and 6 hours after surgery. The neutrophil-lymphocyte ratio, a blood marker of inflammatory stress, is compared before surgery and 6 hours after surgery.
The results are intended to show which drink is better suited to older surgical patients and to support safer and more comfortable fasting practice.
Design. Double-blind, parallel-group randomized controlled trial with two arms and a 1:1 allocation ratio. Participants are recruited consecutively and allocated by computer-assisted block randomization. Setting: Central Surgical Installation and inpatient wards, Prof. Dr. I.G.N.G. Ngoerah General Hospital, Denpasar, Bali.
Procedure. Eligible patients are selected from the elective operating list the day before surgery and give written informed consent. All patients fast from solid food for 6 hours. In the reception area, age, sex, height, weight, body mass index, last meal and fasting duration are recorded. Baseline gastric ultrasound (right lateral decubitus, curvilinear probe) and capillary blood glucose are measured, and a blood sample for neutrophil and lymphocyte counts is taken. The participant then drinks 400 mL of the assigned drink within 15 to 30 minutes, 2 hours before anesthesia. Two hours later gastric ultrasound and blood glucose are repeated by the same operator. Anesthesia is neuraxial: spinal bupivacaine heavy 0.5% 10 to 12.5 mg at L3-L4, or epidural bupivacaine up to 0.25% in 10 to 12 mL. Six hours after the end of surgery, blood glucose and a complete blood count are repeated. Surgery type, duration and blood loss are taken from the electronic medical record.
Masking. The drinks are served in identical, opaque, unbranded, closed containers labeled A or B, with the same volume, temperature and timing, and drunk through a straw. The participant, the ultrasound operator who collects the data, and the data analyst do not know the allocation. The person who prepares and hands over the drinks knows it. The drinks differ in taste and appearance, so masking of participants relies on the opaque containers.
Hypothesis. The primary hypothesis is one-sided: gastric volume 2 hours after the maltodextrin drink is lower than after sugar water. The hypotheses for blood glucose and neutrophil-lymphocyte ratio are two-sided.
Sample size. The planned sample is 62 participants (31 per arm). The calculation used blood glucose as the driving outcome (28 per group, alpha 0.05, power 80%) plus 10% allowance for dropout.
Safety. Adverse events (allergy, nausea, bloating, regurgitation, hypotension, bradycardia) are managed by the anesthesia team, recorded, and reported to the hospital patient safety committee and the ethics committee.
Analysis. Normality is tested with Kolmogorov-Smirnov and variance homogeneity with Levene. Two groups are compared with the independent t-test or Mann-Whitney test. Repeated measurements use repeated-measures ANOVA or the Friedman test. Confounders are examined by stratification and a general linear model. Software: IBM SPSS Statistics 29.
1,111 studies on the registry are indexed under Respiratory Aspiration; 219 are open to participants now.
This study's planned enrollment of 62 is above the median of 42 across 897 interventional studies indexed under Respiratory Aspiration.
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Exclusion Criteria:
Participants drink 400 mL (4 packs of 100 mL) of a ready-to-drink clear maltodextrin carbohydrate beverage (Maltodex, about 200 kcal) within 15 to 30 minutes, 2 hours before anesthesia, after 6 hours of fasting from solid food. The drink is served in an opaque coded container with a straw.
Dietary Supplement: Maltodextrin carbohydrate drink
Participants drink 400 mL of clear sugar water made with about 50 g of sucrose (table sugar) in drinking water (about 200 kcal) within 15 to 30 minutes, 2 hours before anesthesia, after 6 hours of fasting from solid food. The drink is served in an opaque coded container with a straw, identical to the other arm.
Dietary Supplement: Sugar water
400 mL (4 x 100 mL) of ready-to-drink clear maltodextrin beverage (Maltodex, PT Finusoprima Farma Internasional). Per 100 mL: 50 kcal, 13 g carbohydrate of which 4 g sugars, 15 mg sodium, vitamin A and zinc at 15% of daily value each. Single dose, drunk within 15 to 30 minutes, 2 hours before anesthesia. Unlike the comparator it contains added vitamin A and zinc.
Also known as: Maltodex
400 mL of clear solution prepared by the hospital nutrition installation by dissolving about 50 g of sucrose (table sugar) in drinking water to a final volume of 400 mL (about 200 kcal, no fat, no protein). Single dose, drunk within 15 to 30 minutes, 2 hours before anesthesia.
Also known as: Sucrose solution
Gastric volume 2 hours after carbohydrate loading
Gastric volume in mL estimated from bedside antral ultrasound in the right lateral decubitus position using the Perlas formula: volume (mL) = 27.0 + 14.6 x right-lateral antral cross-sectional area (cm2) - 1.28 x age (years). One operator, blinded to allocation.
Time frame: 2 hours after finishing the study drink, before anesthesia
Change in blood glucose from before loading to 2 hours after loading
Capillary blood glucose in mg/dL measured with an Accu-Chek glucometer before the drink and 2 hours after it.
Time frame: Before the drink and 2 hours after the drink
Change in neutrophil-lymphocyte ratio from before surgery to 6 hours after surgery
Neutrophil-lymphocyte ratio calculated from the complete blood count differential (Sysmex XN-3000) of the last preoperative sample and a sample taken 6 hours after the end of surgery.
Time frame: Last preoperative sample and 6 hours after the end of surgery
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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