Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery
Intraoperative Intravenous Dextrose Administration and the Incidence of Nausea and Vomiting After the Gynecologic Laparoscopic Surgery A Randomized Double-Blinded Controlled Study
The investigators tested the hypothesis that administration of intravenous dextrose as a maintenance fluid in gynecologic laparoscopic surgery would reduce the incidence and severity of postoperative nausea and vomiting (PONV) compared with normal saline solution in the same dose.
A prospective randomized double blinded controlled study was conducted. Eighty six participants were randomized to dextrose solution (n= 42) or normal saline solution (n= 44). The Bellville postoperative nausea and vomiting scores were recorded until 24 hours after surgery.
調査の概要
詳細な説明
Postoperative nausea and vomiting (PONV) is a major complication in laparoscopic gynecologic surgery. There are limited data and conflicting results from previous studies related to the types of intravenous fluid and a reduction in PONV. The incidence of nausea is slightly greater than the incidence of vomiting (50% vs. 30%). General anesthesia increased the likelihood of PONV 11 times compared with other types of anesthesia. Laparoscopic surgery can further increase the incidence of PONV to 80%.Identified risk factors of PONV included female, history of motion sickness, nonsmoking, younger age, general anesthesia, use of volatile anesthetics and nitrous oxide, opioids, duration of anesthesia, and types of surgery (cholecystectomy, laparoscopic, gynecological). Adequate intravenous fluid hydration is another effective strategy for reducing the baseline risk for PONV (Evidence A2). Previous studies showed that there was no difference in efficacy between crystalloids and colloids when similar volumes were used in surgeries associated with minimal fluid shifts. While liberal intravenous fluid administration, such as 30 ml/ kg of sodium lactate solution, reduced the incidence of PONV after gynecologic laparoscopy compared to another group receiving 10 ml/kg of sodium lactate solution, this strategy did not reduce the PONV in other surgical procedures such as thyroidectomy. Among crystalloid solutions, results from previous studies were conflicting regarding the benefit of intravenous dextrose administration to reducing the PONV. Hypovolemia with and without hypoglycemia after overnight fasting were believed to exacerbate PONV.
The investigators hypothesized that intraoperative infusion of dextrose solution could reduce the incidence and severity of PONV. The investigators proposed to determine the relationship between types of fluid administration and antiemetic requirement and serum glucose in paricipants scheduled for the gynecologic laparoscopy.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- ASA I-II
- elective surgery
- Gynecologic laparoscopic surgery
- give informed consent
Exclusion Criteria:
- pregnancy
- DM
- congestive heart failure
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター:normal saline solution
The patients received normal saline solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.
|
The patients received NSS during surgery
他の名前:
|
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アクティブコンパレータ:dextrose solution
The patients received dextrose solution as a maintenance fluid during surgery in dose of 2 ml/kg/hour.
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The patients received 5%D/N/2 during surgery
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the incidence and severity of postoperative nausea and vomiting
時間枠:24 hour after surgery
|
Bellville score assessment
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24 hour after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Antiemetic drug requirement
時間枠:24 hour after surgery
|
nausea and vomiting drugs requested by the patients
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24 hour after surgery
|
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serum glucose
時間枠:2 hour after surgery
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DTX was assessed
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2 hour after surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Pathomporn Pin-on、Chiang Mai University
出版物と役立つリンク
一般刊行物
- Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.
- Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Koivuranta M, Laara E, Snare L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia. 1997 May;52(5):443-9. doi: 10.1111/j.1365-2044.1997.117-az0113.x.
- Sinclair DR, Chung F, Mezei G. Can postoperative nausea and vomiting be predicted? Anesthesiology. 1999 Jul;91(1):109-18. doi: 10.1097/00000542-199907000-00018.
研究記録日
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研究開始 (実際)
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研究の完了 (実際)
試験登録日
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最終確認日
詳しくは
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saline solutionの臨床試験
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Shandong University募集
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