Pre-operative 5% Dextrose Infusion & PONV

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Dextrose 5%, normal saline

About this trial

This is an interventional prevention trial for Nausea, Postoperative

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: ASA physical status I and ll. Patients undergoing middle ear surgeries, mastoidectomy, or tympanoplasty Exclusion Criteria: history of dependence or use of antiemetics history of motion sickness presence of psychiatric illness pregnant and lactating women cardiovascular disorders (Ischemic heart diseases, congestive heart failure and valvular diseases) Diabetic patients

Sites / Locations

Faculty of Medicine- Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Placebo Comparator

Arm Label

Control group

Dextrose group

Normal saline group

Arm Description

Patients will be fasted and not receiving any pre-operative fluids

Patients will take 100ml/HR of clear fluids (apple juice) during the fasting hours till 2 hrs before the operation and will receive dextrose 5% infusion at a rate of 1ml/kg/h 2hrs before the operation and till the end of the operation

Patients will take 100ml/HR of water during the fasting hours till 2 hrs before the operation and will receive normal saline 0.9% at a rate of 1ml/kg/h (group NS) intravenously (IV)2hrs before the operation and till the end of the operation

Outcomes

Primary Outcome Measures

PONV

incidence

Secondary Outcome Measures

Full Information

NCT ID

NCT05947981

First Posted

July 9, 2023

Last Updated

July 9, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05947981

Brief Title

Pre-operative 5% Dextrose Infusion & PONV

Official Title

Is Pre-operative Infusion of 5% Dextrose Effective in Reducing the Incidence of PONV in Middle Ear Surgery? A Blinded Randomized Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2023 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

With this study, we aim to compare the efficacy of pre-operative dextrose-containing fluid infusion with other fluid for the prevention of PONV in middle ear surgeries.

Detailed Description

We hypothesized that maintenance of stable level of blood glucose in addition to adequate hydration through preoperative intravenous dextrose 5% infusion will have a rule in decreasing the incidence and severity of PONV; as it reduces insulin resistance and decreases gastric acid secretion; which may contribute to PONV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea, Postoperative

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Patients will be fasted and not receiving any pre-operative fluids

Arm Title

Dextrose group

Arm Type

Active Comparator

Arm Description

Patients will take 100ml/HR of clear fluids (apple juice) during the fasting hours till 2 hrs before the operation and will receive dextrose 5% infusion at a rate of 1ml/kg/h 2hrs before the operation and till the end of the operation

Arm Title

Normal saline group

Arm Type

Placebo Comparator

Arm Description

Patients will take 100ml/HR of water during the fasting hours till 2 hrs before the operation and will receive normal saline 0.9% at a rate of 1ml/kg/h (group NS) intravenously (IV)2hrs before the operation and till the end of the operation

Intervention Type

Dietary Supplement

Intervention Name(s)

Dextrose 5%, normal saline

Intervention Description

Decrease fasting hours

Primary Outcome Measure Information:

Title

PONV

Description

incidence

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA physical status I and ll. Patients undergoing middle ear surgeries, mastoidectomy, or tympanoplasty Exclusion Criteria: history of dependence or use of antiemetics history of motion sickness presence of psychiatric illness pregnant and lactating women cardiovascular disorders (Ischemic heart diseases, congestive heart failure and valvular diseases) Diabetic patients

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shymaa Fathy, M.D.

Phone

1000455897

Ext

002

Email

angel6122003@yahoo.com

Facility Information:

Facility Name

Faculty of Medicine- Cairo University

City

Cairo

ZIP/Postal Code

11562

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shymaa Fathy, M.D.

Phone

23649281

Ext

002

Email

pg@kasralainy.edu.eg

Nausea, Postoperative

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial