Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting

• Registration Number: NCT04726436
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

All patients signed informed consent after excluding patients not candidate for the study.patients were divided to three groups, taking either 0.9% saline as control group(group C), dextrose 5%(group D5) or dextrose 10%(group D10).

Study Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-24
• Study Start: 2021-01-25
• Study First Posted: 2021-01-27
• Primary Completion: 2021-04-01
• Study Completion: 2021-05-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting within 24 hour	24hour after surgery	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).

Secondary Outcome Measures

Name	Time	Method
Number of doses of antiemetics required to control PONV.	24hour postoperative	Frequency of doses of antiemetics required to control postoperative nausea and vomiting, initial antiemetic treatment was 10 mg slow IV metoclopramide for occurred nausea or 4 mg IV ondansetron for occurred nausea \& vomiting or if the previous treatment failed for nausea
Number of classes of antiemetics	24 hour postoperative	Frequency of classes of antiemetics required to control postoperative nausea and vomiting, Initial antiemetic treatment was 10 mg slow IV metoclopramide for occurred nausea or 4 mg IV ondansetron for occurred nausea \& vomiting or if the previous treatment failed for nausea

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Assuit, Egypt