Sevoflurane Versus Propofol for Laryngeal Mask Airway Placement in Children Undergoing Surgery
Comparison of Sevoflurane and Propofol for Laryngeal Mask Airway Insertion in Children
The goal of this clinical trial is to compare two commonly used anesthetic medicines, sevoflurane and propofol, for inserting a laryngeal mask airway (LMA) in children undergoing minor elective surgery. A laryngeal mask airway is a device placed in the throat to help children breathe safely during anesthesia.
The main questions this study aims to answer are:
- Does sevoflurane produce a faster onset of anesthesia than propofol?
- Is there a difference between sevoflurane and propofol in the time required to achieve jaw relaxation for LMA insertion?
- Is there a difference between the two medicines in the time required for successful LMA insertion?
The researchers hypothesize that children receiving sevoflurane will have a shorter induction time than those receiving propofol.
A total of 170 children aged 4 to 12 years who are undergoing minor surgical procedures below the umbilicus will participate in the study. Participants will be randomly assigned to receive either intravenous propofol or inhaled sevoflurane for induction of anesthesia.
During the procedure, the anesthesia team will measure the time taken to lose consciousness, the time required to achieve adequate jaw relaxation, and the time needed for successful insertion of the laryngeal mask airway. These measurements will help determine which anesthetic agent provides better conditions for LMA insertion in children.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
Punjab Province
-
Multan、Punjab Province、パキスタン、60000
- Children's Hospital and Institute of Child Health Multan
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- ASA physical status 1 and 2
- Undergoing elective minor surgical procedures below umbilicus
- Procedure lasting less than 60 min
Exclusion Criteria:
- Recent respiratory tract infection
- Bronchial asthma
- Family history of malignant hyperthermia
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Propofol Group
Children in this group will receive intravenous propofol as the induction agent for general anesthesia prior to laryngeal mask airway (LMA) insertion.
|
Intravenous propofol 3 mg/kg bolus will be administered for induction of general anesthesia before LMA insertion in pediatric patients.
|
|
実験的：Sevoflurane Group
hildren in this group will receive inhalational sevoflurane for induction of general anesthesia prior to laryngeal mask airway (LMA) insertion.
|
Sevoflurane 7% will be delivered via inhalation in a nitrous oxide/oxygen mixture (2:1) for induction of general anesthesia prior to LMA insertion in pediatric patients.
|
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 |
|---|---|---|
|
Time to Induction of Anesthesia
時間枠：From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
|
Time (in seconds) measured from administration of the induction agent (propofol or sevoflurane) to loss of consciousness, defined as loss of verbal response and loss of eyelash reflex in pediatric patients undergoing elective surgery for laryngeal mask airway insertion.
|
From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Jaw Relaxation
時間枠：From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.
|
Time (in seconds) measured from administration of induction agent to adequate jaw relaxation, defined as sufficient mouth opening (>4 cm) allowing insertion of laryngeal mask airway.
|
From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.
|
|
Time to Laryngeal Mask Airway (LMA) Insertion
時間枠：From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
|
Time (in seconds) measured from administration of induction agent to successful insertion of laryngeal mask airway using standard technique.
|
From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
|
協力者と研究者
捜査官
- スタディチェア：Syed S Abbas, FCPS、Children's Hospital and Institute of Child Health, Multan
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- U1111-1342-4662
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。