Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery: A Prospective, Randomized, Double-Blind, Controlled Trial
This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.
Premedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.
In this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2.
Secondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.
調査の概要
詳細な説明
This prospective, randomized, double-blind, controlled clinical trial aims to compare intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia.
Premedication is essential in pediatric anesthesia to reduce preoperative anxiety, facilitate parent-child separation, and improve cooperation during anesthesia induction. Oral midazolam is widely used but has limitations such as variable bioavailability and potential adverse behavioral effects. Dexmedetomidine, a selective α2-adrenoreceptor agonist, has emerged as an alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects.
Eligible pediatric patients will be prospectively enrolled and randomly assigned to receive either intranasal dexmedetomidine or oral midazolam. A double-blind design will be maintained by administering both oral and intranasal preparations in each group. Premedication will be administered prior to anesthesia induction, and perioperative clinical parameters will be recorded.
This study is expected to provide clinically relevant evidence regarding the effectiveness and safety of intranasal dexmedetomidine compared to oral midazolam, potentially contributing to improved premedication strategies in pediatric anesthesia.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Siyament Cangir, M.D.
- 電話番号：+905534411047
- メール：siyamentcangir@gmail.com
研究連絡先のバックアップ
- 名前：Fatma K Acil, M.D.
- 電話番号：+905337225225
- メール：acilfatma@gmail.com
研究場所
-
-
Outside of the US
-
Diyarbakır、Outside of the US、トルコ（Türkiye）、21070
- 募集
- Siyament Cangir
-
コンタクト：
- Fatma Acil, M.D.
- 電話番号：+905337225225
- メール：acilfatma@gmail.com
-
コンタクト：
- Siyament Cangir, M.D.
- 電話番号：+905534411047
- メール：siyamentcangir@gmail.com
-
-
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:
- Pediatric patients aged 2-10 years
- ASA physical status I-II
- Scheduled for elective inguinal or urological surgery under general anesthesia
- Both male and female patients
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Known allergy or hypersensitivity to dexmedetomidine or midazolam
- Presence of significant systemic disease or organ dysfunction
- Cardiac arrhythmia or congenital heart disease
- Neurological or behavioral disorders, including developmental delay
- Chronic use of analgesics or other medications that may affect study outcomes
- Anticipated difficult airway
- Nasal pathology that may interfere with intranasal drug administration
- Emergency surgery
- Inability to obtain written informed consent from parents or legal guardians
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 |
|---|---|
|
アクティブコンパレータ：Midazolam Group
Participants in this group will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) as premedication 30 minutes prior to anesthesia induction, along with intranasal placebo to maintain blinding.
This approach ensures consistent administration routes across study groups.
|
Oral midazolam administered at a dose of 0.5 mg/kg (maximum 15 mg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
他の名前：
|
|
実験的：Dexmedetomidine Group
Participants in this group will receive intranasal dexmedetomidine at a dose of 2 mcg/kg (maximum 200 mcg) as premedication prior to anesthesia induction, along with oral placebo to maintain blinding.
|
Intranasal dexmedetomidine administered at a dose of 2 mcg/kg (maximum 200 mcg) approximately 30 minutes prior to anesthesia induction for premedication in pediatric patients.
他の名前：
|
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 |
|---|---|---|
|
Proportion of patients achieving adequate sedation at anesthesia induction
時間枠：Approximately 30 minutes after premedication, at anesthesia induction
|
Adequate sedation is defined as a Ramsay Sedation Score (RSS) ≥2 assessed immediately before mask application at the time of anesthesia induction
|
Approximately 30 minutes after premedication, at anesthesia induction
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parent-child separation anxiety score
時間枠：At parent-child separation before anesthesia induction
|
Parent-child separation anxiety will be assessed using the Parental Separation Anxiety Scale (PSAS). The scale ranges from 1 to 4, where 1 indicates "calm/easy separation" and 4 indicates "crying/extreme difficulty in separation." Higher scores represent worse outcomes (higher levels of anxiety). A score of >2 is defined as significant separation anxiety. Unit of Measure: Units on a scale |
At parent-child separation before anesthesia induction
|
|
Mask acceptance at induction
時間枠：At the time of mask application during anesthesia induction
|
Mask acceptance will be assessed using the Mask Acceptance Scale (MAS ) at the time of mask application during anesthesia induction.
Mask Acceptance will be defined as WDS 1-2.
|
At the time of mask application during anesthesia induction
|
|
Postoperative emergence agitation
時間枠：At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
Emergence agitation will be assessed using the Watcha Behavior Scale (WDS).
Agitation will be defined as WDS >2.
|
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
|
Need for rescue sedation
時間枠：From premedication until anesthesia induction
|
Requirement for rescue sedation during the preoperative period will be recorded as yes/no.
|
From premedication until anesthesia induction
|
|
PACU recovery time
時間枠：During PACU stay until discharge criteria are met
|
Recovery time will be defined as the time from admission to the post-anesthesia care unit until achievement of Aldrete score ≥9.
|
During PACU stay until discharge criteria are met
|
|
Postoperative pain score
時間枠：At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
Postoperative pain will be assessed using the FLACC scale.
|
At PACU admission, at 5 and 10 minutes, and then every 10 minutes until Aldrete score is ≥9
|
|
Extubation time
時間枠：Intraoperative to immediate postoperative period
|
Extubation time will be defined as the interval from discontinuation of volatile anesthetic to removal of the endotracheal tube.
|
Intraoperative to immediate postoperative period
|
|
Mean Arterial Pressure (MAP)
時間枠：At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
Mean arterial pressure (MAP) will be monitored to evaluate hemodynamic stability during the perioperative period. Unit of Measure: mmHg |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
|
Heart Rate (HR)
時間枠：At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
Heart rate (HR) will be recorded to monitor cardiac stability and response to anesthesia. Unit of Measure: Beats per minute (bpm) |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
|
Oxygen Saturation (SpO2)
時間枠：At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
SpO2 levels will be monitored via pulse oximetry to evaluate respiratory and hemodynamic status. Unit of Measure: Percentage (%) |
At baseline (pre-induction), every 5 minutes during the intraoperative period (approx. 30-60 min), and every 5 minutes during the PACU stay until discharge (approx. 120 min).
|
協力者と研究者
捜査官
- スタディディレクター：Fatma Acil, M.D.、Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- 27/01/2026-35
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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。