Remifentanil and Fentanyl in Dental Surgery (REFEDS)
Түлхүүр үгс
Хураангуй
Тодорхойлолт
The study included 46 adult patients with cognitive impairment who underwent day-case dental surgery under general anesthesia with propofol aiming to keep a BIS-values range between 40-45. Nasal tracheal intubation was performed in all patients while neuromuscular blockade was achieved by rocuronium 0.6 mg/kg iv and repetitive doses of rocuronium of 10 mg iv, if needed.
Patients were randomly allocated receive for intraoperative analgesia either fentanyl 50 μg iv bolus (group F, n=23) or continuous infusion of remifentanil 0.5-1 μg/kg/min (group R, n=23). Randomization was performed using using a computer-generated randomization schedule.
Intraoperatively, patients in both groups received IV granisetron 3 mg, methylprednisolone 125 mg and clindamycin 600 mg, while atropine 0.02 mg/kg and neostigmine (0.05 mg/kg) was administered to to reverse neuromuscular blockade. Intraoperative monitoring included non-invasive measurement of arterial blood pressure, electrocardiogram, pulse oxymetry, capnography and Bispectral Sedation Index (BIS®).
Postoperatively, patients remained under surveillance in the post-anesthesia care unit [PACU] for 3 h. Postoperative pain was assessed for the first 12 postoperative hours, at 30 min time-intervals for the first 3 hours, and every 3 hours thereafter by an independent observer, blinded to the study group, using the Wong-Baker faces pain rating scale (0-6). If pain scores were ≥3 a rescue dose of paracetamol 12.5 mg/kg iv was administered.
Inflammation markers and stress hormones [cortisol, Tumor necrosis factor (TNF-a), substance-P, melatonin and β-endorphin] were measured in each patient before induction of anesthesia, after tracheal intubation and at the end of operation.
Statistical Analysis was performed using Kolmogorov-Smirnov test, Student's unpaired t-test or Repeated Measures ANOVA with Holm's post-hoc analysis appropriately. A p value less than 0.05 was considered statistically significant.
Огноо
| Сүүлд баталгаажуулсан: | 10/31/2015 |
| Эхлээд оруулсан: | 11/24/2015 |
| Тооцоолсон элсэлтийг оруулсан: | 11/29/2015 |
| Эхлээд нийтэлсэн: | 12/01/2015 |
| Сүүлийн шинэчлэлтийг оруулсан: | 11/29/2015 |
| Сүүлийн шинэчлэлтийг нийтэлсэн: | 12/01/2015 |
| Сургалтын бодит эхлэх огноо: | 09/30/2005 |
| Тооцоолсон анхан шатны ажил дуусах огноо: | 06/30/2009 |
| Судалгааны ажлыг дуусгах өдөр: | 08/31/2009 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Drug: Remifentanil
Drug: Fentanyl
Үе шат
Arm Groups
| Гар | Хөндлөнгийн оролцоо / эмчилгээ |
|---|---|
| Active Comparator: Remifentanil Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h. | |
| Active Comparator: Fentanyl Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia. |
Эрхийн шалгуур
| Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
| Суралцах боломжтой хүйс | All |
| Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
| Шалгуур үзүүлэлтүүд | Inclusion Criteria: - Patients with cognitive impairment - of category II according to the American Society of Anesthesiology (ASA) classification - scheduled for elective dental surgery with short duration Exclusion Criteria: - Patients of more than category II of American Society of Anesthesiology (ASA) classification - Prolonged duration of surgery (>1 hour) |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. Change from baseline plasma cortisol values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
2. Change from baseline plasma tumor necrosis factor-α (TNF-α) values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
3. Change from baseline plasma substance-P values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
4. Change from baseline plasma melatonin values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
5. Change from baseline plasma β-endorphin values at 1 hour [At 1 hour after the induction of anesthesia and surgery]
Хоёрдогч үр дүнгийн арга хэмжээ
1. Differences in intraoperative systolic arterial blood pressure values (mm Hg) between the two study groups [1 hour]
2. Differences in intraoperative heart rate values (bmp) between the two study groups [1 hour]
3. Differences in postoperative pain scores scores between the two study groups [Up to 12 postoperative hours]
