Pre-operative 5% Dextrose Infusion & PONV

NCT ID: NCT05947981

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Nausea, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Dextrose group

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

Group Type ACTIVE_COMPARATOR

Dextrose 5%, normal saline

Intervention Type DIETARY_SUPPLEMENT

Decrease fasting hours

Normal saline group

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

Group Type PLACEBO_COMPARATOR

Dextrose 5%, normal saline

Intervention Type DIETARY_SUPPLEMENT

Decrease fasting hours

Interventions

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Dextrose 5%, normal saline

Decrease fasting hours

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Shymaa Fathy

Assistant professor of anesthesia and SICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine- Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-206-2022

Identifier Type: -

Identifier Source: org_study_id

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