Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP (ES-ERCP)
Effects of Esketamine-Propofol Versus Sufentanil-Propofol Sedation on Hypoxemia and Hypotension During Endoscopic Retrograde Cholangiopancreatography (ERCP)
This study compares two anesthesia medications, esketamine and sufentanil, used together with propofol during ERCP procedures. The goal is to find out which combination provides better safety and comfort for people undergoing ERCP.
Participants will be randomly assigned to receive either esketamine or sufentanil during sedation. Researchers will monitor blood oxygen levels, blood pressure, and recovery time during and after the procedure to evaluate safety and effectiveness.
調査の概要
詳細な説明
This randomized controlled trial compares the effects of intravenous esketamine and intravenous sufentanil as adjuncts to propofol sedation in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
The study aims to evaluate differences in intraoperative hemodynamic stability, oxygenation, sedation quality, and recovery profiles between the two sedation strategies.
Participants will be randomly assigned to receive either esketamine or sufentanil in combination with propofol during the ERCP procedure. Sedation will be titrated to achieve an adequate level of sedation based on clinical assessment.
Standard monitoring will be applied throughout the procedure, including continuous pulse oximetry and non-invasive blood pressure measurement at predefined time points. Hemodynamic instability, including hypotension and oxygen desaturation, will be managed according to predefined clinical protocols.
Adverse events will be recorded throughout the perioperative period and assessed for severity and relatedness to the study interventions.
The study is designed to reflect routine clinical anesthesia practice while systematically comparing two commonly used adjunct analgesic strategies for procedural sedation in ERCP patients.
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：Tingting Fan, PhD
- 電話番号：86+13439211460
- メール：fantt_aki@126.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged ≥18 years
- Patients scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP)
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) between 18.5 and 30 kg/m²
- Patients requiring sedation for ERCP
- Ability to provide written informed consent voluntarily
Exclusion Criteria:
- Allergy or contraindication to propofol, esketamine, sufentanil, or related medications
- Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
- Severe dysfunction of the heart, lungs, liver, or kidneys
- History of central nervous system disorders or psychiatric disorders
- Anticipated difficult airway
- History of psychiatric disorders or contraindications to ketamine use
- Inability to communicate or provide informed consent
- Requirement for general anesthesia with endotracheal intubation or intraoperative conversion to general anesthesia with intubation
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 |
|---|---|
|
実験的：Esketamine arm
Participants receive intravenous esketamine in combination with propofol for procedural sedation during ERCP.
Esketamine is administered as an adjunct analgesic during induction of sedation, while propofol is continuously infused and titrated according to clinical sedation requirements.
|
Intravenous esketamine is administered as an adjunct analgesic during induction of sedation for ERCP.
It is used in combination with continuously infused propofol, with dosing titrated to achieve adequate procedural sedation.
This regimen differs from the comparator arm in that esketamine is used as the primary analgesic agent instead of an opioid.
|
|
アクティブコンパレータ：Sufentanil arm
Participants receive intravenous sufentanil in combination with propofol for procedural sedation during ERCP.
Sufentanil is administered as an adjunct analgesic during induction of sedation, while propofol is continuously infused and titrated according to clinical sedation requirements.
|
Intravenous sufentanil is administered as an adjunct analgesic during induction of sedation for ERCP.
It is used in combination with continuously infused propofol, with dosing titrated to achieve adequate procedural sedation.
This regimen differs from the comparator arm in that sufentanil is used as the opioid-based analgesic instead of esketamine.
|
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 |
|---|---|---|
|
Incidence of intraoperative hypoxemia
時間枠：Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.
|
Hypoxemia is defined as peripheral oxygen saturation (SpO₂) < 90% lasting ≥ 10 seconds.
Peripheral oxygen saturation (SpO₂) were recorded at six predefined time points: T0, T1, T2, T3, T4, T5.
|
Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of intraoperative hypotension
時間枠：Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.
|
Hypotension was defined as a reduction in mean arterial pressure (MAP) of ≥30% from baseline or a systolic arterial pressure (SAP) <90 mmHg.
Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP) were recorded at six predefined time points: T0, T1, T2, T3, T4, T5.
|
Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
induction time
時間枠：During anesthesia induction
|
Time from administration of the study drug to successful insertion of the endoscope
|
During anesthesia induction
|
|
Recovery time
時間枠：From the end of the procedure to recovery from sedation
|
Time from discontinuation of propofol administration to recovery of consciousness, defined as achieving an Observer's Assessment of Alertness/Sedation (OAA/S) score of 5.
The score ranges from 1 to 5, with higher scores indicating a higher level of alertness.
Recovery was defined as achieving an OAA/S score of 5 (responds readily to name spoken in a normal tone).
|
From the end of the procedure to recovery from sedation
|
|
Patient body movements
時間枠：Throughout the procedure
|
Number of patient body movements during the procedure requiring additional propofol administration or interfering with the procedure
|
Throughout the procedure
|
|
Endoscopist satisfaction
時間枠：Immediately after completion of the procedure
|
Endoscopist satisfaction with sedation conditions, assessed using a 10-point numeric rating scale (1 = extremely dissatisfied, 10 = extremely satisfied).
|
Immediately after completion of the procedure
|
|
Patient satisfaction
時間枠：Before discharge from the recovery room (PACU)
|
Patient satisfaction with the anesthesia experience, assessed using a 10-point numeric rating scale (1 = extremely dissatisfied, 10 = extremely satisfied)
|
Before discharge from the recovery room (PACU)
|
|
Total propofol dose
時間枠：From induction of sedation to the end of the procedure
|
The total amount of propofol administered during the procedure, including the induction dose and additional doses required to maintain adequate sedation
|
From induction of sedation to the end of the procedure
|
|
Aldrete recovery score
時間枠：Upon arrival at the post-anesthesia care unit (PACU) and before discharge from PACU
|
Recovery from sedation was assessed using the modified Aldrete recovery score, which evaluates activity, respiration, circulation, consciousness, and oxygen saturation.
The score ranges from 0 to 10, with higher scores indicating better recovery
|
Upon arrival at the post-anesthesia care unit (PACU) and before discharge from PACU
|
|
Airway intervention
時間枠：From induction of sedation to the end of the procedure
|
The need for airway interventions to manage sedation-related respiratory compromise, including chin lift, jaw thrust, oral airway insertion, or mask ventilation during the procedure
|
From induction of sedation to the end of the procedure
|
協力者と研究者
スポンサー
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
追加の関連 MeSH 用語
その他の研究ID番号
- BFHHZS20260216
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