Postoperative Outcomes After Positive Intraoperative Messages
キーワード
概要
日付
| 最終確認済み: | 05/31/2018 |
| 最初に提出された: | 04/28/2016 |
| 提出された推定登録数: | 05/05/2016 |
| 最初の投稿: | 05/08/2016 |
| 最終更新が送信されました: | 06/25/2018 |
| 最終更新日: | 06/27/2018 |
| 実際の研究開始日: | 02/29/2016 |
| 一次完了予定日: | 01/31/2018 |
| 研究完了予定日: | 02/28/2018 |
状態または病気
介入/治療
Behavioral: BIS 40-60
Behavioral: BIS 20-40
Behavioral: Placebo
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: BIS 40-60 Patient with intraoperative Bispectral Index (BIS) 40-60. | Behavioral: BIS 40-60 The message "You are in the operating room. Everything is going very well. When you wake up you will be very calm, you will not feel pain and you will not have nausea" will be played in greek language by headphones to the patient when the Bispectral Index (BIS) is 40-60. |
| Experimental: BIS 20-40 Patient with intraoperative Bispectral Index (BIS) 20-40. | Behavioral: BIS 20-40 The message "You are in the operating room. Everything is going very well. When you wake up you will be very calm, you will not feel pain and you will not have nausea" will be played in greek language by headphones to the patient when the Bispectral Index (BIS) is 20-40. |
| Placebo Comparator: Placebo Placebo group | Behavioral: Placebo The headphones will be placed on patient's ears but no message will be played. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Laparoscopic cholecystectomy. - ASA 1-3 Exclusion Criteria: - Hearing loss. - Chronic use of drugs which affect the central nervous system (antidepressants, antiepileptics, opioids, benzodiazepines) |
結果
主な結果の測定
1. Pain Intensity. [Within an average of 15 minutes after emergence from general anesthesia.]
2. Postoperative paracetamol consumption. [24 hours after emergence from general anesthesia.]
3. Postoperative tramadol consumption. [24 hours after emergence from general anesthesia.]
4. Emergence agitation (yes/no). [Within an average of 10 minutes after emergence from general anesthesia.]
5. Postoperative nausea. [24 hours after emergence from general anesthesia.]
6. Postoperative vomiting. [24 hours after emergence from general anesthesia.]
7. Pain Intensity. [1 hour after the end of surgery.]
8. Pain Intensity. [6 hours after the end of surgery.]
9. Pain Intensity. [12 hours after the end of surgery.]
10. Pain Intensity. [24 hours after the end of surgery.]
二次的な結果の測定
1. Explicit memory. [24 hours after emergence from general anesthesia.]
