Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy

Sponsor

Weifang Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05932160

Collaborator

(none)

108

Enrollment

Location

Arms

Anticipated Duration (Months)

27.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Other: 5% glucose Other: lactated ringers	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Research Investigator

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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, 0.5-2 h, 2-24 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 (500 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-2 h, 2-24 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.

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, 0.5-2 h, 2-24 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 (500 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-2 h, 2-24 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.

Outcome Measures

Primary Outcome Measures

Postoperative nausea and vomiting [Measured at 0.5 hours postoperatively.]
The severity and incidence of PONV at 0.5 hours postoperatively.
Postoperative nausea and vomiting [Measured at 2 hours postoperatively.]
The severity and incidence of PONV at 2 hours postoperatively.
Postoperative nausea and vomiting [Measured at 24 hours postoperatively.]
The severity and incidence of PONV at 24 hours postoperatively.

Secondary Outcome Measures

Consumption of postoperative analgesic [Approximately 24 hours after surgery.]
Record the type and dosage of postoperative analgesic within 24 hours after surgery.
Postoperative pain response [Measured at 0.5 hours postoperatively.]
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).
Postoperative pain response [Measured at 2 hours postoperatively.]
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).
Postoperative pain response [Measured at 24 hours postoperatively.]
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).
Recovery time of PACU [Approximately 24 hours after surgery.]
Record PACU recovery time in hours. The criteria for discharge from PACU was the achievement of a modified Aldrete score ≥ 9.
Consumption of postoperative rescue antiemetic [Approximately 24 hours after surgery.]
Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiang Liu	Weifang	Shandong	China	265100

Sponsors and Collaborators

Weifang Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiang Liu, Research investigator, Weifang Medical University

ClinicalTrials.gov Identifier:

NCT05932160

Other Study ID Numbers:

2023YX104

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jiang Liu, Research investigator, Weifang Medical University

PONV

Additional relevant MeSH terms:

Vomiting

Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Jul 7, 2023