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