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NCT05947981 Clinical Trial

Pre-operative 5% Dextrose Infusion & PONV

Nausea, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05947981
Other study ID # MS-206-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date January 31, 2024

Study information
Verified date March 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Dextrose 5%, normal saline
Decrease fasting hours

Locations
Country Name City State
Egypt Faculty of Medicine- Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary PONV incidence 24 hours
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