Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

NCT04726436 | Completed DMC

• 1 other identifier: Dextrose PONV
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea and vomiting within 24 hour

  Number of participants who experienced PONV grade ≥2 as assessed by PONV score . The PACU nurses assessed and documented PONV using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; thus 5 scores were recorded during PACU stay. A 24-hour PONV assessment that elicited any nausea and emesis episode since PACU discharge was obtained by a blinded investigator by telephone or in person at the patient's bedside (delayed PONV).

  24hour after surgery

Secondary Outcomes (2)

• Number of doses of antiemetics required to control PONV.

  24hour postoperative

• Number of classes of antiemetics

  24 hour postoperative

Study Arms (3)

Dextrose 5%

EXPERIMENTAL

100 mL/ hour of dextrose 5% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon to assess the timing and dosing of dextrose solution effect on PONV.

Other: Dextrose 5% in water

Dextrose 10%

EXPERIMENTAL

100 mL/ hour of dextrose 10% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon

Other: Dextrose 10%

Saline placebo

PLACEBO COMPARATOR

100 mL/ hour of normal saline were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon

Other: Saline placebo

Interventions

Dextrose 5% in water OTHER

One hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery

Dextrose 5%

Dextrose 10% OTHER

One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery

Dextrose 10%

Saline placebo OTHER

One hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery

Also known as: Normal saline

Saline placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female non-smokers adults (age 18-65 years)
• ASA I-II who were listed for elective surgery under general anesthesia (surgery which is risk for PONV).

You may not qualify if:

• Severe hypertension
• Coagulopathy
• Significant hepatic or renal disease
• Diabetes mellitus or abnormal blood glucose on the morning of surgery
• Withdrawal of consent
• Severe intraoperative hypotension requiring large volume intravascular fluid treatment
• Protocol violations including nitrous oxide administration.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

Location

Related Publications (1)

• Zorrilla-Vaca A, Marmolejo-Posso D, Stone A, Li J, Grant MC. Perioperative Dextrose Infusion and Postoperative Nausea and Vomiting: A Meta-analysis of Randomized Trials. Anesth Analg. 2019 Oct;129(4):943-950. doi: 10.1213/ANE.0000000000004019.

  PMID: 30649067 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Glucose; Water; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and ICU

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 27, 2021
• Study Start: January 25, 2021
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

EG (1)