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Pre-operative 5% Dextrose Infusion & PONV

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Nausea, Postoperative

Treatments

Dietary Supplement: Dextrose 5%, normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05947981
MS-206-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

105 participants in 3 patient groups, including a placebo group

Control group
No Intervention group
Description:
Patients will be fasted and not receiving any pre-operative fluids
Dextrose group
Active Comparator group
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
Treatment:
Dietary Supplement: Dextrose 5%, normal saline
Normal saline group
Placebo Comparator group
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
Treatment:
Dietary Supplement: Dextrose 5%, normal saline

Trial contacts and locations

1

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Central trial contact

Shymaa Fathy, M.D.

Data sourced from clinicaltrials.gov

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