深度異丙酚平衡鎮靜麻醉在胃食道及大腸鏡檢查的應用(I)阿芬太尼及芬太尼恢復時間比較 (II)老年患者的前瞻性評估

Application of balanced propofol deep sedation in esophagogastroduodenal endoscopy and colonoscopy: (I) Comparison between the recovery time of alfentanil and fentanyl (II) Prospective evaluation of elderly patients

何謂明(Wai-Meng Ho)

指導教授 ： 周明智

中山醫學大學/醫學院/醫學研究所/博士(2015年)

https://doi.org/10.6834/CSMU.2015.00125

摘要

第一部份

研究目的：醫學上以異丙酚平衡鎮靜麻醉 (BPS) 靜脈麻醉至中度鎮靜麻醉 (清醒麻醉、意識鎮靜) 並應用在內視鏡檢查上，有日漸增加的趨勢。但是，針對 BPS 深度鎮靜麻醉的對照研究不多。阿芬太尼 (Alfentanil) 是芬太尼(Fentanyl) 的類似合成物，卻比芬太尼有更快速和更短效的的優點，適合使用在門診手術上。所以在合理的假設下，在 BPS 中使用低劑量阿芬太尼也可能較低劑量芬太尼有更快速的恢復。 所以本研究旨在探討 深度異丙酚平衡鎮靜麻醉 在胃大腸鏡檢查時使用 低劑量阿芬太尼 Alfentanil 與 低劑量芬太尼 Fentanyl 其恢復時間的比較。
研究方法及資料：本研究是一個前瞻性、隨機分組、雙盲臨床研究。在272位門診健康體檢病人，接受診斷性 Esophagogastroduodenal（EGD）內視鏡和大腸鏡檢查，經由電腦隨機化分派至實驗組或對照組。實驗組使用阿芬太尼 (Alfentanil)、咪達唑崙(Midazolam) 及異丙酚 (Propofol)，對照組使用芬太尼 (Fentanyl)、咪達唑崙 (Midazolam) 和異丙酚 (Propofol)。 二組病人均麻醉至深度鎮靜麻醉 (Deep Sedation)。二組病患的恢復時間、患者滿意度、安全性、有效性和成本效益等均加以比較。
研究結果： 260位病人參與分析，分別是阿芬太尼組129位和芬太尼組131位。在性別、年齡、體重、BMI和ASA分佈上兩組間沒有顯著差異。此外，在病人恢復時間、病患滿意度、Propofol 的用量、清醒時間、鎮靜麻醉相關的心肺併發症等都沒有顯著差異。儘管病人都達到深度鎮靜麻醉，但所有心肺併發症都是輕微且短暫的（10.8％，28/260）。無嚴重不良事件包括使用氟馬西尼 (Flumazenil)、 輔助通氣、永久性的傷害或死亡、檢查過程暫時或永久性的中斷等。 然而，芬太尼比阿芬太尼便宜新台幣（NT$）103元（大約4美元），導致兩組之間總成本有顯著差異。
結論與建議：這項隨機、雙盲臨床研究的結果，顯示在胃大腸鏡檢查中，這兩組鎮靜麻醉藥物組合，在病人的恢復時間、患者滿意度、異丙酚 (Propofol) 的用量、清醒時間、麻醉相關心肺併發症等並沒有顯著差異。 但是，芬太尼的價格比阿芬太尼便宜新台幣103元（約 4美元）。

第二部份

研究目的：異丙酚平衡鎮靜麻醉 (BPS) 應用在內視鏡檢查上有日漸被重視的趨勢。但是，深度異丙酚平衡鎮靜麻醉 (BPDS) 在老年患者的研究不多。這研究的目的在評估和比較深度異丙酚平衡鎮静麻醉 (BPDS) 在老年人（≧ 65歲）與年輕患者（< 65歲）進行雙向內視鏡檢查（同一位病人當天進行胃十二指腸和大腸鏡檢查 BDE ）時的臨床療效和安全性。
研究方法及資料：本研究是一個前瞻性，橫斷面臨床研究。資料來自接受BDE的健康體檢門診病人。臨床和內視鏡資料的取得獲得所有患者知情與同意。老年人患者與年輕患者的恢復時間、患者滿意度、盲腸插管率、 BPDS （異丙酚組合咪達唑崙和阿芬太尼麻醉至深度鎮靜麻醉 Deep Sedation）的安全性和有效性等均進行比較。
研究結果： 689位病人參與分析，分別是老年人患者102位和年輕患者587位。 相較於年輕患者 (<65歲)，老年患者 (>65歲) 也有類似的恢復時間（14.31±5.38與 13.92 ± 4.85分鐘，P =0.462）、病人滿意度（手術後24小時1-10分數字量表測定， 9.78±0.44 與 9.70±0.60，P =0.215）和盲腸插管率（96.1％ 與 96.9％，P =0.553 ）。平均總檢查時間老年患者較年輕患者多 2.30分鐘 （16.78±4.66 與14.48±4.20分鐘，P = 0.000），主要是由於大腸曲折性增加。 雖然老年患者較年輕患者的患病率顯著上升並反映在高百分比的 ASA III 級上（P = 0.000），但清醒時間沒有顯著差異（5.67±3.08 與 5.05±2.98 分鐘，P =0.056），鎮靜麻醉相關的心肺併發症也沒有顯著差異（2.9％ 對 3.1％，P =1.000）。 沒有病人需要輔助通氣或提前終止檢查。 鎮靜劑異丙酚的劑量老年患者顯著較年輕患者低（87.79±18.47 與 113.53±27.58毫克，P = 0.000）。
結論與建議： BPDS 提供65歲以上老年患者進行 BDE 檢查時安全與有效的麻醉，雖然老年患者異丙酚用量顯著較年輕患者低，但卻具有與年輕患者一樣的恢復快，高病患者滿意度與高盲腸插管率。

關鍵字

異丙酚平衡鎮靜麻醉 ； 阿芬太尼 ； 芬太尼 ； 深度鎮靜麻醉 ； 診斷性內視鏡檢查 ； 成本效益 ； 患者滿意 ； 恢復時間 ； 老年患者 ； 雙向內視鏡檢查

並列摘要

First Part

Objective：There is increasing interest in balanced propofol sedation (BPS) titrated to moderate sedation (conscious sedation) for endoscopic procedures. However, few controlled studies on BPS targeted to deep sedation for diagnostic endoscopy were found. Alfentanil, a rapid and short-acting synthetic analog of fentanyl, appears to offer clinically significant advantages over fentanyl during outpatient anesthesia. It is reasonable to hypothesize that low dose of alfentanil used in BPS might also result in more rapid recovery as compared with fentanyl.

Methods and Materials：A prospective, randomized and double-blinded clinical trial of alfentanil, midazolam and propofol versus fentanyl, midazolam and propofol in 272 outpatients undergoing diagnostic esophagogastroduodenal endoscopy (EGD) and colonoscopy for health examination were enrolled. Randomization was achieved by using the computer-generated random sequence. Each combination regimen was titrated to deep sedation. The recovery time, patient satisfaction, safety and the efficacy and cost benefit between groups were compared.

Results：260 participants were analyzed, 129 in alfentanil group and 131 in fentanyl group. There is no significant difference in sex, age, body weight, BMI and ASA distribution between two groups. Also, there is no significant difference in recovery time, satisfaction score from patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between two groups. Though deep sedation was targeted, all cardiopulmonary complications were minor and transient (10.8%, 28/260). No serious adverse events including the use of flumazenil, assisted ventilation, permanent injury or death, and temporary or permanent interruption of procedure were found in both groups. However, fentanyl is New Taiwan Dollar (NT$) 103 (approximate US$ 4) cheaper than alfentanil, leading to a significant difference in total cost between two groups.

Conclusion and Suggestion：This randomized, double-blinded clinical trial showed that there is no significant difference in the recovery time, satisfaction score from
patients, propofol consumption, awake time from sedation, and sedation-related cardiopulmonary complications between the two most common sedation regimens for EGD and colonoscopy in our hospital. However, fentanyl is NT$103 (US$ 4) cheaper than alfentanil in each case.

Second Part

Objective：There is increasing interest in balanced propofol sedation (BPS) for endoscopic procedures. However, controlled studies on BPS targeted to deep sedation (BPDS) for elderly patients were rare. The aim of this study was to evaluate and compare the differences of clinical safety and efficacy of BPDS between elderly (≧65 years) and younger patients (<65 years) undergoing bidirectional endoscopy (same-day EGD and colonoscopy in a same patient, BDE).

Methods and Materials：A prospective, cross-sectional study of outpatients attending BDE for health examination was designed. Clinical and endoscopic data were obtained from all consenting patients. The recovery time, patient satisfaction, cecal intubation rate, the safety and the efficacy of BPDS (propofol in combination with midazolam and alfentanil titrated to deep sedation) were compared between groups.

Results： 689 patients (102 elderly and 587 aged <65 years) were enrolled. Compared to the patients aged <65 years, the elderly patients had similar levels of recovery time (14.31 ± 5.38 vs. 13.92 ± 4.85 min, P = 0.462), patient satisfaction score (24 hours after procedure, VAS9.78 ± 0.44 vs. 9.70 ± 0.60, P =0.215) and cecal intubation rate (96.1% vs. 96.9%, P = 0.553). The mean total procedure time was 2.30 minutes longer in the elderly patients (16.78 ± 4.66 vs. 14.48 ± 4.20 min, P = 0.000) mainly due to an increased rate of colonic tortuosity. Though the elderly patients had significant higher level of co-morbidity reflected by an ASA score of class III (P = 0.000), there were no significant differences in awake time from sedation (5.67 ± 3.08 vs. 5.05 ± 2.98 min, P = 0.056), and sedation-related cardiopulmonary complications (2.9% vs. 3.1%, P = 1.000) between two groups. No patient required assisted ventilation or premature termination of the procedure. The elderly patients needed lower sedation doses of propofol than the younger adults (87.79 ± 18.47 vs. 113.53 ± 27.58 mg, P = 0.000).

Conclusion and Suggestion：BPDS for BDE in elderly patients over 65 years old are as safe and effective as in younger patients. Rapid recovery, high patient satisfaction and high cecal intubation rate are also achieved though lower propofol doses are needed in elderly patients.

並列關鍵字

Balanced propofol sedation ； alfentanil ； fentanyl ； deep sedation ； diagnostic endoscopy ； cost benefit ； balanced propofol deep sedation ； bidirectional endoscopy ； elderly patients ； recovery time ； patient satisfaction

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