Back to resultsEffect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy
Primary Purpose
Postoperative Nausea and Vomiting
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
5% glucose
lactated ringers
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring PONV
Eligibility Criteria
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
Sites / Locations
- Jiang LiuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Postoperative nausea and vomiting
The severity and incidence of PONV at 0.5 hours postoperatively.
Postoperative nausea and vomiting
The severity and incidence of PONV at 2 hours postoperatively.
Postoperative nausea and vomiting
The severity and incidence of PONV at 24 hours postoperatively.
Secondary Outcome Measures
Consumption of postoperative analgesic
Record the type and dosage of postoperative analgesic within 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).
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).
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).
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.
Consumption of postoperative rescue antiemetic
Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05932160
Brief Title
Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy
Official Title
Research Investigator
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weifang Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
PONV
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
5% glucose
Other Intervention Name(s)
5% dextrose
Intervention Description
Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU.
Intervention Type
Other
Intervention Name(s)
lactated ringers
Intervention Description
Patients in the control group were infused intravenously with lactated ringers (500 ml/h) in the PACU.
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
The severity and incidence of PONV at 0.5 hours postoperatively.
Time Frame
Measured at 0.5 hours postoperatively.
Title
Postoperative nausea and vomiting
Description
The severity and incidence of PONV at 2 hours postoperatively.
Time Frame
Measured at 2 hours postoperatively.
Title
Postoperative nausea and vomiting
Description
The severity and incidence of PONV at 24 hours postoperatively.
Time Frame
Measured at 24 hours postoperatively.
Secondary Outcome Measure Information:
Title
Consumption of postoperative analgesic
Description
Record the type and dosage of postoperative analgesic within 24 hours after surgery.
Time Frame
Approximately 24 hours after surgery.
Title
Postoperative pain response
Description
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).
Time Frame
Measured at 0.5 hours postoperatively.
Title
Postoperative pain response
Description
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).
Time Frame
Measured at 2 hours postoperatively.
Title
Postoperative pain response
Description
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).
Time Frame
Measured at 24 hours postoperatively.
Title
Recovery time of PACU
Description
Record PACU recovery time in hours. The criteria for discharge from PACU was the achievement of a modified Aldrete score ≥ 9.
Time Frame
Approximately 24 hours after surgery.
Title
Consumption of postoperative rescue antiemetic
Description
Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.
Time Frame
Approximately 24 hours after surgery.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Liu, B.S
Phone
17667192336
Email
Time1987fx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Liu, B.S
Organizational Affiliation
Weifang Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiang Liu
City
Weifang
State/Province
Shandong
ZIP/Postal Code
265100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Liu, B.S
Phone
17667192336
Email
Time1987fx@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy
We'll reach out to this number within 24 hrs