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Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dextrose 5% in water
Dextrose 10%
Saline placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dextrose 5%

Dextrose 10%

Saline placebo

Arm Description

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.

100 mL/ hour of dextrose 10% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon

100 mL/ hour of normal saline were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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

Full Information

First Posted
January 24, 2021
Last Updated
August 24, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04726436
Brief Title
Dextrose Effect on Postoperative Nausea and Vomiting (PONV)
Official Title
The Impact of Timing and Dosing of Dextrose Solution on Postoperative Nausea and Vomiting.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextrose 5%
Arm Type
Experimental
Arm Description
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.
Arm Title
Dextrose 10%
Arm Type
Experimental
Arm Description
100 mL/ hour of dextrose 10% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon
Arm Title
Saline placebo
Arm Type
Placebo Comparator
Arm Description
100 mL/ hour of normal saline were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon
Intervention Type
Other
Intervention Name(s)
Dextrose 5% in water
Intervention Description
One hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery
Intervention Type
Other
Intervention Name(s)
Dextrose 10%
Intervention Description
One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery
Intervention Type
Other
Intervention Name(s)
Saline placebo
Other Intervention Name(s)
Normal saline
Intervention Description
One hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting within 24 hour
Description
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).
Time Frame
24hour after surgery
Secondary Outcome Measure Information:
Title
Number of doses of antiemetics required to control PONV.
Description
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
Time Frame
24hour postoperative
Title
Number of classes of antiemetics
Description
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
Time Frame
24 hour postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
State/Province
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30649067
Citation
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.
Results Reference
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Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

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