Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy

Research Investigator

This study is to explore the relationship between intravenous infusion of dextrose during emergence from anesthesia and the incidence of PONV in patients undergoing gynecology laparoscopy (GL).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Other: 5% glucose; Other: lactated ringers

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiang Liu, B.S; Phone Number: 17667192336; Email: Time1987fx@163.com

Study Locations

• China
  • Shandong
    • Weifang, Shandong, China, 265100
      • Recruiting
      • Jiang Liu
      • Contact: Jiang Liu, B.S; Phone Number: 17667192336; Email: Time1987fx@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. ASA I or II;
2. Performing gynecologic laparoscopic procedures under general anesthesia;

Exclusion Criteria:

1. age <18 or >75
2. severe hypertension,diabetes mellitus, significant hepatic or renal disease
3. inability to follow protocol
4. refusal to participant

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 (400 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
Active Comparator: Control group; Patients in the control group were infused intravenously with ringer lactate solution (400 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: lactated ringers; Patients in the control group were infused intravenously with lactated ringers (500 ml/h) in the PACU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting	The severity and incidence of PONV at 0.5 hours postoperatively.	Measured at 0.5 hours postoperatively.
Postoperative nausea and vomiting	The severity and incidence of PONV at 2 hours postoperatively.	Measured at 2 hours postoperatively.
Postoperative nausea and vomiting	The severity and incidence of PONV at 24 hours postoperatively.	Measured at 24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of postoperative analgesic	Record the type and dosage of postoperative analgesic within 24 hours after surgery.	Approximately 24 hours after surgery.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 0.5 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 0.5 hours postoperatively.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 2 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 2 hours postoperatively.
Postoperative pain response	The Visual Analog Score was used to assess pain response at 24 hours postoperatively. The score ranges from 0 (pain free or no pain) to 10 (worst pain).	Measured at 24 hours postoperatively.
Recovery time of PACU	Record PACU recovery time in hours. The criteria for discharge from PACU was the achievement of a modified Aldrete score ≥ 9.	Approximately 24 hours after surgery.
Consumption of postoperative rescue antiemetic	Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.	Approximately 24 hours after surgery.

Collaborators and Investigators

• Sponsor: Weifang Medical University
• Investigators: Principal Investigator: Jiang Liu, B.S, Weifang Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: PONV
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 2023YX104

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