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

NCT03139383 | Completed DMC

• 2 other identifiers: ANE-2557-023232519-04-17
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

postoperative nausea; postoperative vomiting; gynecologic laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• the incidence and severity of postoperative nausea and vomiting

  Bellville score assessment

  24 hour after surgery

Secondary Outcomes (2)

• Antiemetic drug requirement

  24 hour after surgery

• serum glucose

  2 hour after surgery

Study Arms (2)

normal saline solution

PLACEBO COMPARATOR

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

Other: saline solution

dextrose solution

ACTIVE COMPARATOR

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

Other: dextrose solution

Interventions

dextrose solution OTHER

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

Also known as: 5% dextrose in half strength saline solution

dextrose solution

saline solution OTHER

The patients received NSS during surgery

Also known as: normal saline solution

normal saline solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: the surgical procedure was done only in female patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnancy
• congestive heart failure

Sponsors & Collaborators

• Chiang Mai University: lead

Related Publications (4)

• 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.

  PMID: 10422935 BACKGROUND

• 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.

  PMID: 10485781 BACKGROUND

• 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.

  PMID: 9165963 BACKGROUND

• 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.

  PMID: 24356162 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Glucose; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pathomporn Pin-on

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients did not know the type of intravenous fluid they received during the surgery. The outcome assessors were blineded too.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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

Study Record Dates

• First Submitted: April 30, 2017
• First Posted: May 4, 2017
• Study Start: September 30, 2014
• Primary Completion: September 28, 2015
• Study Completion: October 31, 2015
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share