Journal of Mazandaran University of Medical Sciences
مجله دانشگاه علوم پزشکی مازندران
J Mazandaran Univ Med Sci
Medical Sciences
http://jmums.mazums.ac.ir
1
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1735-9260
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1401
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2022
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مقایسه اثربخشی ترکیب پروپوفول-کتامین با پروپوفول-فنتانیل بر زمان ریکاوری در کولونوسکوپی:
یک کارآزمایی بالینی دوسوکور با گروه کنترل
Comparing the Efficiency of Propofol-Ketamine Combination and Propofol-Fentanyl on Recovery Time in Colonoscopy: A Double Blind Randomized Controlled Clinical Trial
بیهوشی
anesthesia
پژوهشي-کامل
Research(Original)
<span style="font-size:12pt"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><span lang="FA" style="line-height:80%"><span style="font-family:"B Koodak""><span style="color:black"><span style="letter-spacing:-.1pt">سابقه</span></span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Koodak""><span style="color:black"><span style="letter-spacing:-.1pt"> و هدف:</span></span></span></span> <span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">رژیم دارویی مناسب طی انجام کولونوسکوپی، از موارد مورد توجه در بیهوشی است. </span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">این مطالعه با هدف مقایسه اثربخشی ترکیب پروپوفول-کتامین با پروپوفول-فنتانیل بر روی زمان ریکاوری در کولونوسکوپی انجام شد.</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:#0e101a"></span></span></span></span></span></span></span></span><br>
<span style="font-size:12pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Koodak""><span style="color:black"><span style="letter-spacing:-.1pt">مواد و روش</span></span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.1pt"></span></span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Koodak""><span style="color:black"><span style="letter-spacing:-.1pt">ها:</span></span></span></span> <span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">در این کارآزمایی بالینی تصادفی یک سوکور، 200 بیمار 60-18 ساله کاندید انجام کولونوسکوپی، با روش بلوک تصادفی</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">سازی به دو گروه فنتانیل- پروپوفول و کتامین- پروپوفول تخصیص یافتند. زمان ریکاوری</span> <span style="color:black">(زمان پایان تزریق دارو <span style="letter-spacing:-.1pt">تا رسیدن به نمره </span></span></span></span><span dir="LTR" style="font-size:10.0pt"><span style="line-height:80%"><span style="color:black"><span style="letter-spacing:-.1pt">Steward</span></span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.1pt"> برابر 6) به</span></span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.1pt">عنوان پیامد اولیه و علایم حیاتی،کل دوز مصرفی پروپوفول </span></span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.1pt">و رضایت کولونوسکوپیست</span></span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"> به عنوان پیامد ثانویه در </span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">دو گروه مورد مقایسه قرار گرفتند.</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"></span></span></span></span></span></span></span></span></span></span><br>
<span style="font-size:12pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Koodak""><span style="color:black"><span style="letter-spacing:-.2pt">یافته</span></span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.2pt"></span></span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Koodak""><span style="color:black"><span style="letter-spacing:-.2pt">ها:</span></span></span></span> <span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">در بررسی زمان ریکاوری در دو گروه، در گروه فنتانیل- پروپوفول این مقدار برابر با 0/89</span></span></span><span lang="FA" style="font-size:10.0pt"><span style="line-height:80%"><span style="color:black">±</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">2/97 دقیقه و گروه کتامین- پروپوفول برابر با 1/73</span></span></span><span lang="FA" style="font-size:10.0pt"><span style="line-height:80%"><span style="color:black">±</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">8/84 دقیقه به</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">دست آمد(0/001</span></span></span><span lang="FA" style="font-size:10.0pt"><span style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">></span></span></span></span><span dir="LTR" style="font-size:10.0pt"><span style="line-height:80%"><span style="color:black">P</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">).<b> </b>میزان فشارخون سیستولیک و دیاستولیک و تعداد ضربان قلب در گروه فنتانیل- پروپوفول بعد از تزریق دارو به</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">طور معنی</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">داری نسبت به گروه کتامین- پروپوفول کاهش نشان داد(0/001</span></span></span><span lang="FA" style="font-size:10.0pt"><span style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">></span></span></span></span><span dir="LTR" style="font-size:10.0pt"><span style="line-height:80%"><span style="color:black">P</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">) و این اختلاف از زمان تزریق تا پنج دقیقه پس از اتمام کولونوسکوپی نیز ادامه داشت.</span></span></span> <span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">در گروه فنتانیل- پروپوفول صفر مورد و در پروپوفول- کتامین 28 نفر (28 درصد) دچار </span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">بیقراری </span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">شدند که از لحاظ آماری تفاوت معنیداری نشان داد(0/001</span></span></span><span lang="FA" style="font-size:10.0pt"><span style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">></span></span></span></span><span dir="LTR" style="font-size:10.0pt"><span style="line-height:80%"><span style="color:black">P</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">). میزان رضایت کولونوسکوپیست و میزان دوز مصرفی پروپوفول به صورت معنی</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">داری در گروه کتامین- پروپوفول بهتر بود(0/05</span></span></span><span lang="FA" style="font-size:10.0pt"><span style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">></span></span></span></span><span dir="LTR" style="font-size:10.0pt"><span style="line-height:80%"><span style="color:black">P</span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">).</span></span></span></span></span></span></span></span></span></span><br>
<span style="font-size:12pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="line-height:80%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Koodak""><span style="color:black"><span style="letter-spacing:-.2pt">استنتاج:</span></span></span></span> <span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.1pt">ترکیب فنتانیل- پروپوفول زمان ریکاوری سریع</span></span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="letter-spacing:-.1pt"></span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.1pt">تر و بی</span></span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="letter-spacing:-.1pt"></span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.1pt">قراری کم</span></span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="letter-spacing:-.1pt"></span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.1pt">تری از کتامین- پروپوفول دارد و در بیماران</span></span></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"> تحت کولونوسکوپی الکتیو با توجه به اهمیت این موارد ارجح است، ولی ترکیب کتامین-</span></span></span> <span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">پروپوفول ثبات همودینامیک بهتر، رضایتمندی بیش</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">تر کولونوسکوپیک و میزان دوز مصرفی پروپوفول کم</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""></span></span><span lang="FA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black">تری داشت و زمانی که ثبات همودینامیک مد نظر باشد، این ترکیب پیشنهاد میگردد.</span></span></span><span lang="AR-SA" style="line-height:80%"><span style="font-family:"B Zar""><span style="color:black"><span style="letter-spacing:-.2pt"></span></span></span></span></span></span></span></span></span></span></span><br>
<span style="font-size:12pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="line-height:85%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><span lang="AR-SA" style="font-size:4.0pt"><span style="line-height:85%"><span style="font-family:"B Koodak""><span style="color:black"></span></span></span></span></span></span></span></span></span></span></span><br>
<span style="font-size:12pt"><span style="line-height:85%"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="font-family:"Times New Roman","serif""><span lang="FA" style="font-size:10.0pt"><span style="line-height:85%"><span style="font-family:"B Zar"">شماره ثبت کارآزمایی بالینی : 1</span></span></span><span dir="LTR" style="font-size:8.0pt"><span style="line-height:85%">N</span></span><span lang="FA" style="font-size:10.0pt"><span style="line-height:85%"><span style="font-family:"B Zar"">20190529043750</span></span></span><span dir="LTR" style="font-size:8.0pt"><span style="line-height:85%">IRCT</span></span><b><i><span lang="FA" style="font-size:10.0pt"><span style="line-height:85%"><span style="font-family:"2 Davat""></span></span></span></i></b></span></span></span></span></span><br>
<strong> </strong><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:"Times New Roman","serif""><b><span style="font-size:10.0pt"><span style="line-height:115%"><span style="font-family:"Arial","sans-serif""><span style="letter-spacing:-.2pt">Background and purpose:</span></span></span></span></b> <span style="font-size:10.0pt"><span style="line-height:115%">Appropriate drug regimen during colonoscopy is one of the matters of concern in anesthesia. This study was conducted to compare the efficacy of propofol-ketamine combination and propofol-fentanyl in colonoscopy.</span></span></span></span></span><br>
<span style="font-size:12pt"><span style="text-justify:kashida"><span style="text-kashida:0%"><span style="line-height:115%"><span style="text-autospace:none"><span style="font-family:"Times New Roman","serif""><b><span style="font-size:10.0pt"><span style="line-height:115%"><span style="font-family:"Arial","sans-serif"">Materials and methods:</span></span></span></b><b> </b><span style="font-size:10.0pt"><span style="line-height:115%">In a single-blind randomized clinical trial, 200 patients aged 18-60 years candidate for colonoscopy, were randomly allocated into two groups to receive either fentanyl-propofol (PF) or ketamine-propofol (PK) using block randomization. Recovery time (end of injection until Steward Score was 6) as the primary outcome and vital signs, complications, total dose of propofol, and satisfaction of the doctor performing the colonoscopy as secondary consequence were compared between the two groups.</span></span></span></span></span></span></span></span><br>
<span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:"Times New Roman","serif""><b><span style="font-size:10.0pt"><span style="line-height:115%"><span style="font-family:"Arial","sans-serif"">Results:</span></span></span></b><b> </b><span style="font-size:10.0pt"><span style="line-height:115%">Recovery time was 2.97 ± 0.89 min in the fentanyl-propofol group and 8.84 </span></span><span style="font-size:10.0pt"><span style="line-height:115%">±</span></span><span style="font-size:10.0pt"><span style="line-height:115%"> 1.73 min in ketamine-propofol group (P<0.001). Systolic and diastolic blood pressure and heart rate significantly decreased in the fentanyl-propofol group compared with the other group (P <0.001) which was persistent until five minutes after colonoscopy. Restlessness was seen in 28 patients receiving propofol-ketamine but no patient in fentanyl-propofol group developed this condition (P <0.001). Satisfaction of the doctor performing the colonoscopy and propofol dose were significantly better in patients that received ketamine-propofol (P<0.05).</span></span></span></span></span><br>
<span style="font-size:12pt"><span style="line-height:115%"><span style="vertical-align:top"><span style="font-family:"Times New Roman","serif""><b><span style="font-size:10.0pt"><span style="line-height:115%"><span style="font-family:"Arial","sans-serif"">Conclusion:</span></span></span></b> <span style="font-size:10.0pt"><span style="line-height:115%">Fentanyl-propofol combination was associated with faster recovery time and less restlessness than the ketamine-propofol compound, but the latter combination is recommended as it led to better hemodynamic stability, greater satisfaction of the doctor, and reduced dose of propofol.</span></span><i><span style="font-size:10.0pt"><span style="line-height:115%"></span></span></i></span></span></span></span><br>
<span style="font-size:12pt"><span style="font-family:"Times New Roman","serif""><b><span dir="RTL" lang="AR-SA" style="font-size:7.0pt"><span style="font-family:"B Zar""><span style="letter-spacing:-.1pt"></span></span></span></b></span></span><br>
<span style="font-size:12pt"><span style="font-family:"Times New Roman","serif""><span style="font-size:8.0pt"><span style="letter-spacing:-.1pt"> (Clinical Trials Registry Number: </span></span><span style="font-size:8.0pt"><span style="letter-spacing:-.1pt">IRCT20190529043750N1</span></span><span style="font-size:8.0pt"><span style="letter-spacing:-.1pt">)</span></span><b><i><span style="font-size:8.0pt"><span style="letter-spacing:-.1pt"></span></span></i></b></span></span><br>
کتامین, پروپوفول, فنتانیل, کولونوسکوپی
ketamine, propofol, fentanyl, colonoscopy
113
123
http://jmums.mazums.ac.ir/browse.php?a_code=A-10-12417-2&slc_lang=fa&sid=1
Mohammad
Esmaeili
محمد
اسماعیلی
Dresmaeili48@yahoo.com
1003194753284600149324
1003194753284600149324
No
Assistant Professor, Anesthesiology, Clinical Research Development Unit of Ayatollah Rouhani Hospital, Babol University of Medical Sciences, Babol, Iran
استادیار، گروه بیهوشی، واحد توسعه تحقیقات بیمارستان آیت اله روحانی، دانشگاه علوم پزشکی بابل، بابل، ایران
Ghasem
Yousefinia Pasha
قاسم
یوسف نیا پاشا
rohanresearch88@gmail.com
1003194753284600149323
1003194753284600149323
No
Resident in Anesthesiology, Student Research Committee, Babol University of Medical Sciences, Babol, Iran
دانشجوی دکترای تخصصی بیهوشی ،کمیته تحقیقات دانشجویی، دانشگاه علوم پزشکی بابل، بابل، ایران
Ebrahim
Alijanpour
ابراهیم
علیجانپور
dralijanpour@yahoo.com
1003194753284600149325
1003194753284600149325
No
Assistant Professor, Anesthesiology, Clinical Research Development Unit of Ayatollah Rouhani Hospital, Babol University of Medical Sciences, Babol, Iran
استادیار، گروه بیهوشی، واحد توسعه تحقیقات بیمارستان آیت اله روحانی، دانشگاه علوم پزشکی بابل، بابل، ایران
Mohamad Taghi
Hamidian
سید محمدتقی
حمیدیان
meisamhamidian1982@gmail.com
1003194753284600149326
1003194753284600149326
No
Assistant Professor, Department of Gastroenterology and Hepatology, Clinical Research Development Unit of Ayatollah Rouhani Hospital, Babol University of Medical Sciences, Babol, Iran
استادیار، گروه بیماریهای گوارش و کبد بالغین، واحد توسعه تحقیقات بیمارستان آیت اله روحانی، دانشگاه علوم پزشکی بابل، بابل، ایران
Khadijeh
Ezoji
خدیجه
ازوجی
dr.kh.ezoji@gmail.com
1003194753284600149327
1003194753284600149327
No
Assistant Professor, Department of Community Medicine, Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babal, Iran
استادیار، گروه پزشکی اجتماعی، مرکز تحقیقات عوامل اجتماعی موثر بر سلامت، پژوهشکده سلامت، دانشگاه علوم پزشکی بابل، بابل، ایران
Shahram
Seyfi
شهرام
سیفی
Ficu-ss@yahoo.com
1003194753284600149322
1003194753284600149322
Yes
Assistant Professor, Department of Critical Care Medicine, Clinical Research Development Unit of Ayatollah Rouhani Hospital, Babol University of Medical Sciences, Babol, Iran
استادیار، گروه مراقبتهای ویژه پزشکی، واحد توسعه تحقیقات بیمارستان آیت اله روحانی، دانشگاه علوم پزشکی بابل، بابل، ایران