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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05932160
Other study ID # 2023YX104
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 30, 2023

Study information

Verified date November 2023
Source Weifang Medical University
Contact Jiang Liu, B.S
Phone 17667192336
Email Time1987fx@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Postoperative Nausea and Vomiting
  • Vomiting

Intervention

Other:
5% glucose
Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU.
lactated ringers
Patients in the control group were infused intravenously with lactated ringers (500 ml/h) in the PACU.

Locations

Country Name City State
China Jiang Liu Weifang Shandong

Sponsors (1)

Lead Sponsor Collaborator
Weifang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative nausea and vomiting The severity and incidence of PONV at 0.5 hours postoperatively. Measured at 0.5 hours postoperatively.
Primary Postoperative nausea and vomiting The severity and incidence of PONV at 2 hours postoperatively. Measured at 2 hours postoperatively.
Primary Postoperative nausea and vomiting The severity and incidence of PONV at 24 hours postoperatively. Measured at 24 hours postoperatively.
Secondary Consumption of postoperative analgesic Record the type and dosage of postoperative analgesic within 24 hours after surgery. Approximately 24 hours after surgery.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Consumption of postoperative rescue antiemetic Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery. Approximately 24 hours after surgery.
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