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

NCT ID: NCT03139383

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-10-31

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

normal saline solution

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

Group Type: PLACEBO_COMPARATOR

saline solution

Intervention Type: OTHER

The patients received NSS during surgery

dextrose solution

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

Group Type: ACTIVE_COMPARATOR

dextrose solution

Intervention Type: OTHER

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

Interventions

dextrose solution

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

Intervention Type: OTHER

saline solution

The patients received NSS during surgery

Intervention Type: OTHER

Other Intervention Names

5% dextrose in half strength saline solution; 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Pathomporn Pin on, M.D.

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pathomporn Pin-on

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

References

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.

Reference Type: BACKGROUND

PMID: 10422935 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10485781 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9165963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24356162 (View on PubMed)

Other Identifiers

2519-04-17

Identifier Type: OTHER

Identifier Source: secondary_id

ANE-2557-02323

Identifier Type: -

Identifier Source: org_study_id