Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

The Impact of Timing and Dosing of Dextrose Solution on Postoperative Nausea and Vomiting.

The aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Other: Dextrose 5% in water; Other: Dextrose 10%; Other: Saline placebo

Detailed Description

All patients signed informed consent after excluding patients not candidate for the study.patients were divided to three groups, taking either 0.9% saline as control group(group C), dextrose 5%(group D5) or dextrose 10%(group D10).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt, Assuit universi
      • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female non-smokers adults (age 18-65 years)
• ASA I-II who were listed for elective surgery under general anesthesia (surgery which is risk for PONV).

Exclusion Criteria:

• Severe hypertension
• Coagulopathy
• Significant hepatic or renal disease
• Diabetes mellitus or abnormal blood glucose on the morning of surgery
• Withdrawal of consent
• Severe intraoperative hypotension requiring large volume intravascular fluid treatment
• Protocol violations including nitrous oxide administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dextrose 5%; 100 mL/ hour of dextrose 5% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon to assess the timing and dosing of dextrose solution effect on PONV.	Other: Dextrose 5% in water; One hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery
EXPERIMENTAL: Dextrose 10%; 100 mL/ hour of dextrose 10% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon	Other: Dextrose 10%; One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery
PLACEBO_COMPARATOR: Saline placebo; 100 mL/ hour of normal saline were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon	Other: Saline placebo; One hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting within 24 hour	Number of participants who experienced PONV grade ≥2 as assessed by PONV score . The PACU nurses assessed and documented PONV using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; thus 5 scores were recorded during PACU stay. A 24-hour PONV assessment that elicited any nausea and emesis episode since PACU discharge was obtained by a blinded investigator by telephone or in person at the patient's bedside (delayed PONV).	24hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of doses of antiemetics required to control PONV.	Frequency of doses of antiemetics required to control postoperative nausea and vomiting, initial antiemetic treatment was 10 mg slow IV metoclopramide for occurred nausea or 4 mg IV ondansetron for occurred nausea & vomiting or if the previous treatment failed for nausea	24hour postoperative
Number of classes of antiemetics	Frequency of classes of antiemetics required to control postoperative nausea and vomiting, Initial antiemetic treatment was 10 mg slow IV metoclopramide for occurred nausea or 4 mg IV ondansetron for occurred nausea & vomiting or if the previous treatment failed for nausea	24 hour postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Zorrilla-Vaca A, Marmolejo-Posso D, Stone A, Li J, Grant MC. Perioperative Dextrose Infusion and Postoperative Nausea and Vomiting: A Meta-analysis of Randomized Trials. Anesth Analg. 2019 Oct;129(4):943-950. doi: 10.1213/ANE.0000000000004019.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2021
• Primary Completion (ACTUAL): April 1, 2021
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (ACTUAL): January 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: Dextrose PONV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No