Intraoperative Intravenous Dextrose Administration and the Incidence of Nausea and Vomiting After the Gynecologic Laparoscopic Surgery A Randomized Double-Blinded Controlled Study

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

Sponsors

Lead sponsor: Chiang Mai University

Source Chiang Mai University
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.

Overall Status Completed
Start Date September 30, 2014
Completion Date October 31, 2015
Primary Completion Date September 28, 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
the incidence and severity of postoperative nausea and vomiting 24 hour after surgery
Secondary Outcome
Measure Time Frame
Antiemetic drug requirement 24 hour after surgery
serum glucose 2 hour after surgery
Enrollment 100
Condition
Intervention

Intervention type: Other

Intervention name: dextrose solution

Description: The patients received 5%D/N/2 during surgery

Arm group label: dextrose solution

Other name: 5% dextrose in half strength saline solution

Intervention type: Other

Intervention name: saline solution

Description: The patients received NSS during surgery

Arm group label: normal saline solution

Other name: normal saline solution

Eligibility

Criteria:

Inclusion Criteria:

- ASA I-II

- elective surgery

- Gynecologic laparoscopic surgery

- give informed consent

Exclusion Criteria:

- pregnancy

- DM

- congestive heart failure

Gender: Female

Gender based: Yes

Gender description: the surgical procedure was done only in female patients

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Pathomporn Pin-on Principal Investigator Chiang Mai University
Verification Date

May 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Chiang Mai University

Investigator full name: Pathomporn Pin on, M.D.

Investigator title: Assistant professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: normal saline solution

Arm group type: Placebo Comparator

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

Arm group label: dextrose solution

Arm group type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention 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

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking description: The patients did not know the type of intravenous fluid they received during the surgery. The outcome assessors were blineded too.

Source: ClinicalTrials.gov