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

C

Chiang Mai University

Status

Completed

Conditions

Postoperative Nausea and Vomiting

Treatments

Other: dextrose solution
Other: saline solution

Study type

Interventional

Funder types

Other

Identifiers

NCT03139383
2519-04-17 (Other Identifier)
ANE-2557-02323

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • pregnancy
  • DM
  • congestive heart failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

normal saline solution
Placebo Comparator group
Description:
The patients received normal saline solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.
Treatment:
Other: saline solution
dextrose solution
Active Comparator group
Description:
The patients received dextrose solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.
Treatment:
Other: dextrose solution

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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