NCT05947981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

July 9, 2023

Last Update Submit

March 26, 2024

Conditions

Nausea, Postoperative

Outcome Measures

Primary Outcomes (1)

  • PONV

    incidence

    24 hours

Study Arms (3)

Control group

NO INTERVENTION

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

Dextrose group

ACTIVE COMPARATOR

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

Dietary Supplement: Dextrose 5%, normal saline

Normal saline group

PLACEBO COMPARATOR

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

Dietary Supplement: Dextrose 5%, normal saline

Interventions

Dextrose 5%, normal salineDIETARY_SUPPLEMENT

Decrease fasting hours

Dextrose groupNormal saline group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine- Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

GlucoseSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of anesthesia and SICU

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 17, 2023

Study Start

October 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations

EG(1)