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Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dextrose solution
saline solution
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring postoperative nausea, postoperative vomiting, gynecologic laparoscopic surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I-II
  • elective surgery
  • Gynecologic laparoscopic surgery
  • give informed consent

Exclusion Criteria:

  • pregnancy
  • DM
  • congestive heart failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    normal saline solution

    dextrose solution

    Arm Description

    The patients received normal saline solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.

    The patients received dextrose solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.

    Outcomes

    Primary Outcome Measures

    the incidence and severity of postoperative nausea and vomiting
    Bellville score assessment

    Secondary Outcome Measures

    Antiemetic drug requirement
    nausea and vomiting drugs requested by the patients
    serum glucose
    DTX was assessed

    Full Information

    First Posted
    April 30, 2017
    Last Updated
    May 3, 2017
    Sponsor
    Chiang Mai University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03139383
    Brief Title
    Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery
    Official Title
    Intraoperative Intravenous Dextrose Administration and the Incidence of Nausea and Vomiting After the Gynecologic Laparoscopic Surgery A Randomized Double-Blinded Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 30, 2014 (Actual)
    Primary Completion Date
    September 28, 2015 (Actual)
    Study Completion Date
    October 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chiang Mai University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators tested the hypothesis that administration of intravenous dextrose as a maintenance fluid in gynecologic laparoscopic surgery would reduce the incidence and severity of postoperative nausea and vomiting (PONV) compared with normal saline solution in the same dose. A prospective randomized double blinded controlled study was conducted. Eighty six participants were randomized to dextrose solution (n= 42) or normal saline solution (n= 44). The Bellville postoperative nausea and vomiting scores were recorded until 24 hours after surgery.
    Detailed Description
    Postoperative nausea and vomiting (PONV) is a major complication in laparoscopic gynecologic surgery. There are limited data and conflicting results from previous studies related to the types of intravenous fluid and a reduction in PONV. The incidence of nausea is slightly greater than the incidence of vomiting (50% vs. 30%). General anesthesia increased the likelihood of PONV 11 times compared with other types of anesthesia. Laparoscopic surgery can further increase the incidence of PONV to 80%.Identified risk factors of PONV included female, history of motion sickness, nonsmoking, younger age, general anesthesia, use of volatile anesthetics and nitrous oxide, opioids, duration of anesthesia, and types of surgery (cholecystectomy, laparoscopic, gynecological). Adequate intravenous fluid hydration is another effective strategy for reducing the baseline risk for PONV (Evidence A2). Previous studies showed that there was no difference in efficacy between crystalloids and colloids when similar volumes were used in surgeries associated with minimal fluid shifts. While liberal intravenous fluid administration, such as 30 ml/ kg of sodium lactate solution, reduced the incidence of PONV after gynecologic laparoscopy compared to another group receiving 10 ml/kg of sodium lactate solution, this strategy did not reduce the PONV in other surgical procedures such as thyroidectomy. Among crystalloid solutions, results from previous studies were conflicting regarding the benefit of intravenous dextrose administration to reducing the PONV. Hypovolemia with and without hypoglycemia after overnight fasting were believed to exacerbate PONV. The investigators hypothesized that intraoperative infusion of dextrose solution could reduce the incidence and severity of PONV. The investigators proposed to determine the relationship between types of fluid administration and antiemetic requirement and serum glucose in paricipants scheduled for the gynecologic laparoscopy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting
    Keywords
    postoperative nausea, postoperative vomiting, gynecologic laparoscopic surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    a prospective randomized double-blind controlled study of the incidence and severity of postoperative nausea and vomiting in female participants receiving different types of intravenous fluid solution
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The patients did not know the type of intravenous fluid they received during the surgery. The outcome assessors were blineded too.
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    normal saline solution
    Arm Type
    Placebo Comparator
    Arm Description
    The patients received normal saline solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.
    Arm Title
    dextrose solution
    Arm Type
    Active Comparator
    Arm Description
    The patients received dextrose solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.
    Intervention Type
    Other
    Intervention Name(s)
    dextrose solution
    Other Intervention Name(s)
    5% dextrose in half strength saline solution
    Intervention Description
    The patients received 5%D/N/2 during surgery
    Intervention Type
    Other
    Intervention Name(s)
    saline solution
    Other Intervention Name(s)
    normal saline solution
    Intervention Description
    The patients received NSS during surgery
    Primary Outcome Measure Information:
    Title
    the incidence and severity of postoperative nausea and vomiting
    Description
    Bellville score assessment
    Time Frame
    24 hour after surgery
    Secondary Outcome Measure Information:
    Title
    Antiemetic drug requirement
    Description
    nausea and vomiting drugs requested by the patients
    Time Frame
    24 hour after surgery
    Title
    serum glucose
    Description
    DTX was assessed
    Time Frame
    2 hour after surgery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    the surgical procedure was done only in female patients
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ASA I-II elective surgery Gynecologic laparoscopic surgery give informed consent Exclusion Criteria: pregnancy DM congestive heart failure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pathomporn Pin-on
    Organizational Affiliation
    Chiang Mai University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10422935
    Citation
    Sinclair DR, Chung F, Mezei G. Can postoperative nausea and vomiting be predicted? Anesthesiology. 1999 Jul;91(1):109-18. doi: 10.1097/00000542-199907000-00018.
    Results Reference
    background
    PubMed Identifier
    10485781
    Citation
    Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
    Results Reference
    background
    PubMed Identifier
    9165963
    Citation
    Koivuranta M, Laara E, Snare L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997 May;52(5):443-9. doi: 10.1111/j.1365-2044.1997.117-az0113.x.
    Results Reference
    background
    PubMed Identifier
    24356162
    Citation
    Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.
    Results Reference
    background

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    Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery

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