Demedetomidine and Remifentanil in Electroconvulsive Therapy (ECT)
Comparison of Three Different Anesthetic Methods in ECT
調査の概要
詳細な説明
Various pharmacological agents have been investigated in the Electroconvulsive therapy (ECT) procedures. Dexmedetomidine, widely used for sedation, attenuates stress-induced sympathoadrenal responses, reduces postoperative agitation, improves intraoperative hemodynamic stability, and decreases anesthetic requirements during a variety of surgical procedures. As an α2-adrenergic receptor agonist, dexmedetomidine has been shown to attenuate the hyperdynamic response associated with ECT. Remifentanil is a potent μ-opioid receptor agonist characterized by its rapid onset and ultra-short duration of action due to rapid metabolism and elimination. An additional advantage of opioid agonists is their ability to suppress sympathetic responses without increasing the seizure threshold. Consequently, short-acting opioid analgesics such as remifentanil have been recommended as adjuncts during ECT because they improve hemodynamic stability, facilitate rapid recovery, and may prolong seizure duration.
Both dexmedetomidine and remifentanil have been widely used for sedation in anesthesia practice for many years, and several studies have evaluated their use during ECT . Furthermore, the prescribing information for both agents indicates that they are approved for sedation in operating rooms and intensive care units.
The primary objective of this study is to compare the effects of dexmedetomidine and remifentanil on the hemodynamic response in patients undergoing ECT. The secondary objectives are to evaluate seizure duration and recovery characteristics. We anticipate that the findings of this study will contribute to the identification of a safer and more effective anesthetic approach for patients undergoing ECT.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Zekine Begeç, Prof.Dr
- 電話番号：3112 904223410660
- メール：zekine.begec@inonu.edu.tr
研究連絡先のバックアップ
- 名前：ülkü özgül, prof. dr
- 電話番号：3108 904223410660
- メール：ulku.ozgul@inonu.edu.tr
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
- Patients scheduled for six ECT sessions for a variety of psychiatric conditions
Exclusion Criteria:
- refusal to participate,
- age below 18 or above 60 years
- pregnancy
- asthma
- current use of β-adrenergic blockers
- myocardial infarction within the previous six months
- atrial fibrillation or atrial flutter,
- heart block
- a known personal or family history of hypersensitivity to any of the study drugs
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：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Control group (Group C)
Whereas patients in the control group (Group C) will receive normal saline infused over 10 minutes (total volume: 30 mL).
Immediately after completion of saline infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg in Group C. If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved.
The total propofol dose administered will be recorded.
Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds.
A suprathreshold electrical stimulus will then be delivered using the ECT device
|
Saline will infused over 10 minutes (total volume: 30 mL)
|
|
アクティブコンパレータ：Dexmedetomidine group (Group D)
Patients in the dexmedetomidine group (Group D) will receive intravenous dexmedetomidine at a dose of 0.5 μg/kg infused over 10 minutes (total volume: 30 mL).
Immediately after completion of the study drug infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg.
If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved.
The total propofol dose administered will be recorded.
Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds.
A suprathreshold electrical stimulus will then be delivered using the ECT device
|
Dexmedetomidine at a dose of 0.5 μg/kg will infused over 10 minutes (total volume: 30 mL)
|
|
アクティブコンパレータ：Remifentanil group (Group R)
Patients in the remifentanil group (Group R) will receive intravenous remifentanil at a dose of 1 μg/kg infused over 10 minutes (total volume: 30 mL).Immediately after completion of the study drug infusion, anesthesia will be induced with propofol at a dose of 1 mg/kg.
If an adequate depth of anesthesia is not achieved, as determined by failure to respond to verbal commands and loss of the eyelash reflex, supplemental propofol will be administered in 10 mg increments at 10-second intervals until adequate anesthesia is achieved.
The total propofol dose administered will be recorded.
Following loss of consciousness, rocuronium 0.3 mg/kg will be administered intravenously to all patients to achieve muscle relaxation, after which patients will be ventilated with 100% oxygen for 90 seconds.
A suprathreshold electrical stimulus will then be delivered using the ECT device
|
Remifentanil at a dose of 1 μg/kg will infused over 10 minutes (total 30 ml)
|
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 |
|---|---|---|
|
Hemodynamic response
時間枠：Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
|
Arterial blood pressure will be recorded at the following times.
|
Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
seizure duration
時間枠：up to ten minutes after electrical stimulation
|
After anesthesia induction patients will administered electrical stimulation and seizure duration will measured.
|
up to ten minutes after electrical stimulation
|
|
Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands
時間枠：After seizure in one hour in operation room
|
The time from the end of muscle relaxant administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.
|
After seizure in one hour in operation room
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：zekine begeç, Prof.Dr
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ECT and dexmedetomidine
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