Insulin ResistanceNCT06319144
Effect of Intravenous 5% Dextrose Infusion During Recovery from Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy
A study testing 5% glucose and 0.9% sodium chloride solution in people with Insulin Resistance and Postoperative Nausea and Vomiting, run by Weifang Medical University at 1 site in China.
Trial summary
The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Insulin Resistance, Postoperative Nausea and Vomiting, Quality of Recovery
- What is being tested?
- 5% glucose and 0.9% sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 22 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who meet the indications for painless gastrointestinal endoscopy and are aged 18 to 79 years.
- The patient or his/her guardian or immediate family members gave informed consent;
- American Society of Anesthesiology (ASA) anesthesia risk classification ≤ grade III.
Who cannot join
- Patients with contraindications to sedation/anesthesia for gastrointestinal endoscopy: e.g., severe hepatic and renal dysfunction, cardiac insufficiency;
- Patients receiving chemotherapy and opioid treatment; patients with a history of sleep apnea hypoventilation syndrome;
- Intravenous nutritional support within 8 hours prior to the examination;
- Patients diagnosed with type I or type II diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period.
- Being tested
- 5% glucose, 0.9% sodium chloride solution
- Keywords
- Glucose injection Solution, PONV
- Medical subject headings
- Insulin Resistance, Postoperative Nausea and Vomiting, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% glucoseOther
Also called 5% dextrose, 5% Glucose and sodium chloride injection
Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU.
0.9% sodium chloride solutionOther
Patients in the control group were infused intravenously with 0.9% sodium chloride solution in the PACU.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator. Receives: Other: 5% glucose |
| Control group | Active comparator | Patients in the control group were infused intravenously with 0.9% sodium chloride solution (500 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator. Receives: Other: 0.9% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative blood glucose 30min
A fingertip blood glucose concentration of <3.9 mmol/L was used as a diagnostic criterion for hypoglycemia. Severity and incidence of hypoglycemia at 0.5 hours Preoperative.
Measured: Measurements taken 0.5 hours Preoperative.
Postoperative blood glucose 2h
A fingertip blood glucose concentration of <3.9 mmol/L was used as a diagnostic criterion for hypoglycemia. Severity and incidence of hypoglycemia at 2 hours postoperatively.
Measured: Measured at 2 hours postoperatively.
Dizziness level
The Visual Analogue Scale(VAS) was used to assess the degree of postoperative dizziness in patients undergoing painless gastroenteroscopy.
Measured: Approximately 15min after surgery
Dizziness level
The visual analogue scale (VAS) was used to assess the degree of postoperative dizziness in patients undergoing painless gastroenteroscopy.
Measured: Measured at 0.5 hours postoperatively.
Postoperative nausea and vomiting
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 0.5 hours postoperatively.
Measured: Measured at 0.5 hours postoperatively.
Postoperative nausea and vomiting
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 0.5 hours postoperatively.
Measured: Measured at 2 hours postoperatively.
Secondary outcomes (2)
Anesthesia awakening time
The clinical routine defines the time of awakening from anesthesia as the time between the cessation of anesthesia administration and the opening of the patient's eyes on call.
Measured: Approximately 30min after surgery
Quality of postoperative recovery (QoR40)
The QoR-40 scale provides a true and valid reflection of the impact of various factors on the quality of postoperative recovery.
Measured: Approximately 24hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start15 Mar 2024
- Primary completion20 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weifang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Cheng, Weifang Medical University
- Investigators
- Lin Cheng, B.S, Principal investigator, Weifang People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319144
- Sponsor's protocol ID
- KYLL20240306-1
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2024
- Last updated
- 14 Mar 2025
- 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous 5% Dextrose Infusion During Recovery from Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT06319144
- Acronym / sponsor ID
- KYLL20240306-1
- Keywords
- Glucose injection Solution, PONV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Weifang Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 19 Mar 2024 (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.
The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Other: 5% glucosePatients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator. |
| Control group | Active comparator | Other: 0.9% sodium chloride solutionPatients in the control group were infused intravenously with 0.9% sodium chloride solution (500 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who meet the indications for painless gastrointestinal endoscopy and are aged 18 to 79 years.
- The patient or his/her guardian or immediate family members gave informed consent;
- American Society of Anesthesiology (ASA) anesthesia risk classification ≤ grade III.
Key exclusion criteria (4 listed)
- Patients with contraindications to sedation/anesthesia for gastrointestinal endoscopy: e.g., severe hepatic and renal dysfunction, cardiac insufficiency;
- Patients receiving chemotherapy and opioid treatment; patients with a history of sleep apnea hypoventilation syndrome;
- Intravenous nutritional support within 8 hours prior to the examination;
- Patients diagnosed with type I or type II diabetes.
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 |
|---|---|---|
| 5% glucoseAlso: 5% dextrose, 5% Glucose and sodium chloride injectionPatients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU. | Other | Experimental group |
| 0.9% sodium chloride solutionPatients in the control group were infused intravenously with 0.9% sodium chloride solution in the PACU. | Other | Control group |
Primary outcome
Preoperative blood glucose 30min
Time frame: Measurements taken 0.5 hours Preoperative.
A fingertip blood glucose concentration of <3.9 mmol/L was used as a diagnostic criterion for hypoglycemia. Severity and incidence of hypoglycemia at 0.5 hours Preoperative.
Postoperative blood glucose 2h
Time frame: Measured at 2 hours postoperatively.
A fingertip blood glucose concentration of <3.9 mmol/L was used as a diagnostic criterion for hypoglycemia. Severity and incidence of hypoglycemia at 2 hours postoperatively.
Dizziness level
Time frame: Approximately 15min after surgery
The Visual Analogue Scale(VAS) was used to assess the degree of postoperative dizziness in patients undergoing painless gastroenteroscopy.
Dizziness level
Time frame: Measured at 0.5 hours postoperatively.
The visual analogue scale (VAS) was used to assess the degree of postoperative dizziness in patients undergoing painless gastroenteroscopy.
Postoperative nausea and vomiting
Time frame: Measured at 0.5 hours postoperatively.
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 0.5 hours postoperatively.
Postoperative nausea and vomiting
Time frame: Measured at 2 hours postoperatively.
The Index of Nausea and Vomiting and Retching (INVR) was used in this study. The scale consists of 8 items with 3 dimensions, which can quantify the number of occurrences, duration and severity of symptoms. The scale is scored using the Likert method, with a total of 32 points on a 5-point scale ranging from 0 to 4. The higher the score, the more severe the symptoms of nausea, vomiting, and dry heaving (entries 1, 6, and 7 are reverse scored). According to the score, nausea, vomiting and dry heaving symptoms can be categorized into five grades: 0, I, II, III and IV, and grade ≥I means that the symptom occurs. The severity and incidence of PONV at 0.5 hours postoperatively.
2 secondary outcomes
Anesthesia awakening time
Time frame: Approximately 30min after surgery
Quality of postoperative recovery (QoR40)
Time frame: Approximately 24hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- 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. This study is not recruiting at the moment.
Lin Cheng, B.S principal investigator
Weifang People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% glucose and 0.9% sodium chloride solution in people with Insulin Resistance and Postoperative Nausea and Vomiting, run by Weifang Medical University at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 14 Mar 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative blood glucose 30min (time frame: Measurements taken 0.5 hours Preoperative.). The study lists 6 primary outcomes in all. 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 Mar 2025.