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

NCT06319144 | Completed

• 1 other identifier: KYLL20240306-1
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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 and vomiting, and quality of recovery in the early postoperative period.

Conditions

Insulin Resistance; Postoperative Nausea and Vomiting; Quality of Recovery; Dizzyness

Keywords

Glucose injection Solution; PONV

Outcome Measures

Primary Outcomes (6)

• 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 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 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 Outcomes (2)

• Anesthesia awakening time

  Approximately 30min after surgery

• Quality of postoperative recovery (QoR40)

  Approximately 24hours after surgery

Study Arms (2)

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.

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.

Other: 0.9% sodium chloride solution

Interventions

5% glucose OTHER

Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU.

Also known as: 5% dextrose, 5% Glucose and sodium chloride injection

Experimental group

0.9% sodium chloride solution OTHER

Patients in the control group were infused intravenously with 0.9% sodium chloride solution in the PACU.

Control group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weifang Medical University: lead

Study Sites (1)

Lin Cheng

Weifang, Shandong, 261041, China

Location

MeSH Terms

Conditions

Insulin Resistance; Postoperative Nausea and Vomiting; Dizziness

Interventions

Glucose; Sodium Chloride

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Sensation Disorders; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lin Cheng, B.S

  Weifang People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research investigator

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 15, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 22, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)