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Completed

NCT Number: NCT04726436

Dextrose Effect on Postoperative Nausea and Vomiting (PONV)

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 10%

Other

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

Saline Placebo

Other

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

Other names: Normal saline

Primary outcomes

  1. Postoperative nausea and vomiting within 24 hour

    Time frame: 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 outcomes

  1. Number of doses of antiemetics required to control PONV.

    Time frame: 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

  2. Number of classes of antiemetics

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2021
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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