Effect of Intravenous 5% Dextrose Infusion During Recovery from Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy

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 Overview

• Status: Completed
• Conditions: Insulin Resistance; Postoperative Nausea and Vomiting; Dizzyness; Quality of Recovery
• Intervention / Treatment: Other: 5% glucose; Other: 0.9% sodium chloride solution

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Weifang, Shandong, China, 261041
      • Lin Cheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. patients who meet the indications for painless gastrointestinal endoscopy and are aged 18 to 79 years.
2. The patient or his/her guardian or immediate family members gave informed consent;
3. American Society of Anesthesiology (ASA) anesthesia risk classification ≤ grade III.

Exclusion Criteria:

1. Patients with contraindications to sedation/anesthesia for gastrointestinal endoscopy: e.g., severe hepatic and renal dysfunction, cardiac insufficiency;
2. Patients receiving chemotherapy and opioid treatment; patients with a history of sleep apnea hypoventilation syndrome;
3. Intravenous nutritional support within 8 hours prior to the examination;
4. Patients diagnosed with type I or type II diabetes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental group; 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.	Other: 5% glucose; Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU.; Other Names: 5% dextrose; 5% Glucose and sodium chloride injection
Active Comparator: Control group; 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.	Other: 0.9% sodium chloride solution; Patients in the control group were infused intravenously with 0.9% sodium chloride solution in the PACU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurements taken 0.5 hours Preoperative.
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 at 0.5 hours postoperatively.
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 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.	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 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 at 2 hours postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Approximately 24hours after surgery

Collaborators and Investigators

• Sponsor: Weifang Medical University
• Investigators: Principal Investigator: Lin Cheng, B.S, Weifang People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 22, 2024

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: PONV; Glucose injection Solution
• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Metabolic Diseases; Signs and Symptoms, Digestive; Glucose Metabolism Disorders; Sensation Disorders; Hyperinsulinism; Nausea; Vomiting; Postoperative Nausea and Vomiting; Insulin Resistance; Dizziness
• Other Study ID Numbers: KYLL20240306-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No