Pre-operative 5% Dextrose Infusion & PONV

Not Applicable

Completed

• Conditions: Nausea, Postoperative
• Interventions: Dietary Supplement: Dextrose 5%, normal saline

• Registration Number: NCT05947981
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-07-09
• Study First Submitted QC: 2023-07-09
• Study First Posted: 2023-07-17
• Study Start: 2023-10-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• ASA physical status I and ll.
• Patients undergoing middle ear surgeries, mastoidectomy, or tympanoplasty

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextrose group	Dextrose 5%, normal saline	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
Normal saline group	Dextrose 5%, normal saline	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

Primary Outcome Measures

Name	Time	Method
PONV	24 hours	incidence

Trial Locations

Locations (1)

Faculty of Medicine- Cairo University; 🇪🇬 Cairo, Egypt