NCT05932160

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

June 6, 2023

Last Update Submit

November 2, 2023

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Consumption of postoperative analgesic

    Approximately 24 hours after surgery.

  • Postoperative pain response

    Measured at 0.5 hours postoperatively.

  • Postoperative pain response

    Measured at 2 hours postoperatively.

  • Postoperative pain response

    Measured at 24 hours postoperatively.

  • Recovery time of PACU

    Approximately 24 hours after surgery.

  • +1 more secondary outcomes

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

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

Control group

ACTIVE COMPARATOR

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

Interventions

5% glucoseOTHER

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

Also known as: 5% dextrose
Experimental group
lactated ringersOTHER

Patients in the control group were infused intravenously with lactated ringers (500 ml/h) in the PACU.

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II;
  • Performing gynecologic laparoscopic procedures under general anesthesia;

You may not qualify if:

  • age \<18 or \>75
  • severe hypertension,diabetes mellitus, significant hepatic or renal disease
  • inability to follow protocol
  • refusal to participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiang Liu

Weifang, Shandong, 265100, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

GlucoseRinger's Lactate

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jiang Liu, B.S

    Weifang Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Liu, B.S

CONTACT

17667192336Time1987fx@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Triple (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

June 6, 2023

First Posted

July 6, 2023

Study Start

June 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)