Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

Postoperative Nausea and Vomiting Clinical Trial

Official title:

The Impact of Timing and Dosing of Dextrose Solution on Postoperative Nausea and Vomiting.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726436
• Other study ID #: Dextrose PONV
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: August 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• Dextrose 5% in water
One hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery
• Dextrose 10%
One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery
• Saline placebo
One hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of doses of antiemetics required to control PONV.	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	24hour postoperative
Secondary	Number of classes of antiemetics	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	24 hour postoperative