Dextrose Effect on Postoperative Nausea and Vomiting (PONV)
- Conditions
- Postoperative Nausea and Vomiting
- Interventions
- Other: Dextrose 5% in waterOther: Saline placeboOther: Dextrose 10%
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- 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).
- 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
- Arm && Interventions
Group Intervention Description Dextrose 5% Dextrose 5% in water 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. Saline placebo Saline placebo 100 mL/ hour of normal saline were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon Dextrose 10% Dextrose 10% 100 mL/ hour of dextrose 10% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon
- 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