Respiratory AspirationCHO-GERIGASNCT07872683
Maltodextrin Versus Sugar Water Carbohydrate Loading and Gastric Volume in Geriatric Lower Limb Orthopedic Surgery
A study testing Maltodextrin carbohydrate drink and Sugar water in people with Respiratory Aspiration and Hyperglycemia, run by Udayana University at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Respiratory Aspiration, Hyperglycemia, Inflammation
- What is being tested?
- Maltodextrin carbohydrate drink and Sugar water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older with adequate cognitive function on brief cognitive screening
- ASA physical status II or III
- Elective lower extremity orthopedic surgery under neuraxial anesthesia
Who cannot join
- Emergency or urgent surgery
- Unstable hemodynamics
- Diagnosed gastrointestinal tract pathology
- History of bariatric surgery
- Dressing, wound cover or corset over the abdomen that prevents gastric ultrasound
- Use of a proton pump inhibitor, H2 antagonist or drug affecting gastrointestinal motility (for example metoclopramide, loperamide) in the past week
Show all 9Show fewer
- Unable to lie in the lateral decubitus position
- Body mass index below 19 or 35 kg/m2 and above
- Refuses to take part after informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Prof. Dr. I.G.N.G. Ngoerah General Hospital (RSUP Prof. Dr. I.G.N.G. Ngoerah)
Denpasar, Bali, 80114
Burhan MD, 08276222247, burhan.010@student.unud.ac.id
About this study
Official title: Comparison of Maltodextrin and Sugar Water Carbohydrate Loading on Gastric Volume in Geriatric Patients Undergoing Lower Extremity Orthopedic Surgery
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.
Read the detailed description
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.
- Conditions
- Respiratory Aspiration, Hyperglycemia, Inflammation
- Being tested
- Maltodextrin carbohydrate drink, Sugar water
- Keywords
- maltodextrin, carbohydrate loading, sugar water, gastric ultrasound, gastric volume, geriatric, enhanced recovery after surgery, neutrophil-lymphocyte ratio, blood glucose, neuraxial anesthesia
- Medical subject headings
- Respiratory Aspiration, Hyperglycemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maltodextrin carbohydrate drinkDietary supplement
Also called Maltodex
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.
Sugar waterDietary supplement
Also called Sucrose solution
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.
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin Carbohydrate Loading | Experimental | 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. Receives: Dietary Supplement: Maltodextrin carbohydrate drink |
| Sugar Water Carbohydrate Loading | Active comparator | 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. Receives: Dietary Supplement: Sugar water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours after finishing the study drink, before anesthesia
Secondary outcomes (2)
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.
Measured: 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.
Measured: Last preoperative sample and 6 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start27 Sep 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory AspirationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups, randomized 1:1 with computer-assisted block randomization. Each participant receives one drink once.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Collaborators
- RS Umum Pusat Sanglah, Denpasar
- Responsible party
- Principal investigator, Burhan, Udayana University
- Investigators
- Tjahya Aryasa, Sp.An-TI, Subsp.An.O.(K), Study chair, Rumah Sakit Umum Pusat Sanglah DenpasarI Made Prema Putra, Sp.An-TI, Study chair, Rumah Sakit Umum Pusat Sanglah DenpasarLalu Reza Aldira Akbar, MD, Principal investigator, Rumah Sakit Umum Pusat Sanglah Denpasar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872683
- Sponsor's protocol ID
- 2026.02.1.0818
- Other IDs
- 260805.358, 2754/UN14.2.2.VII.14/LT/2026
- Acronym
- CHO-GERIGAS
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maltodextrin and Sugar Water Carbohydrate Loading on Gastric Volume in Geriatric Patients Undergoing Lower Extremity Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07872683
- Acronym / sponsor ID
- CHO-GERIGAS / 2026.02.1.0818
- Conditions
- Respiratory Aspiration, Hyperglycemia, Inflammation
- Keywords
- maltodextrin, carbohydrate loading, sugar water, gastric ultrasound, gastric volume, geriatric, enhanced recovery after surgery, neutrophil-lymphocyte ratio
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Collaborators
- RS Umum Pusat Sanglah, Denpasar
- Study start
- 27 Sep 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups, randomized 1:1 with computer-assisted block randomization. Each participant receives one drink once.
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin Carbohydrate Loading | Experimental | Dietary Supplement: Maltodextrin carbohydrate drinkParticipants 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. |
| Sugar Water Carbohydrate Loading | Active comparator | Dietary Supplement: Sugar waterParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60 years or older with adequate cognitive function on brief cognitive screening
- ASA physical status II or III
- Elective lower extremity orthopedic surgery under neuraxial anesthesia
Key exclusion criteria (9 listed)
- Emergency or urgent surgery
- Unstable hemodynamics
- Diagnosed gastrointestinal tract pathology
- History of bariatric surgery
- Dressing, wound cover or corset over the abdomen that prevents gastric ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maltodextrin carbohydrate drinkAlso: Maltodex400 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. | Dietary supplement | Maltodextrin Carbohydrate Loading |
| Sugar waterAlso: Sucrose solution400 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. | Dietary supplement | Sugar Water Carbohydrate Loading |
Primary outcome
Gastric volume 2 hours after carbohydrate loading
Time frame: 2 hours after finishing the study drink, before anesthesia
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.
2 secondary outcomes
Change in blood glucose from before loading to 2 hours after loading
Time frame: Before the drink and 2 hours after the drink
Change in neutrophil-lymphocyte ratio from before surgery to 6 hours after surgery
Time frame: Last preoperative sample and 6 hours after the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tjahya Aryasa, Sp.An-TI, Subsp.An.O.(K) study chair
Rumah Sakit Umum Pusat Sanglah Denpasar
I Made Prema Putra, Sp.An-TI study chair
Rumah Sakit Umum Pusat Sanglah Denpasar
Lalu Reza Aldira Akbar, MD principal investigator
Rumah Sakit Umum Pusat Sanglah Denpasar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maltodextrin carbohydrate drink and Sugar water in people with Respiratory Aspiration and Hyperglycemia, run by Udayana University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burhan MD (+62 822 7622 2247, burhan.010@student.unud.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric volume 2 hours after carbohydrate loading (time frame: 2 hours after finishing the study drink, before anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.