Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

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

Detailed Description
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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).

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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Other: Dextrose 5% in water
* Other: Dextrose 10%
* Other: Saline placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dextrose 5%<br>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<br>* One hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery<br>|
| Experimental: Dextrose 10%<br>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%<br>* One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery<br>|
| Placebo Comparator: Saline placebo<br>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<br>* One hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |