Folic Acid Intervention During Recovery
Түлхүүр үгс
Хураангуй
Тодорхойлолт
According to literature review, the incidence of sputum sputum in children is about 38.8% (Reference 1), and the incidence of sputum sputum in the placebo group is 38%, assuming a class of error probability α = 0.05, test efficiency 1-β=0.8, considering folic acid supplementation for 7 days can reduce the incidence of sputum to 23%. A chi-square test is proposed to assess whether there is a difference in the incidence of sputum between groups. Calculated by PASS software, the sample size was 300. Considering the 5% drop rate, a total of 316 inpatients with head and neck and maxillofacial surgery were included, divided into 2 groups, 158 cases in each group.
The PAED score was scored every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation (total score 0-20, score ≥10 is defined as the recovery period).
8.2 secondary observation indicators:
1. Changes in induction of anesthesia, intubation, and central rate (HR) and mean blood pressure (MBP);
2. HR and MBP changes in the resuscitation chamber (T1), 5 min (T2) before extubation, T3 at extubation, and 2 min (T4) after extubation;
3. extubation time and wake-up time;
4. Postoperative Ramsay sedation scores were performed every 10 minutes during recovery, at the time of extubation, and within 30 minutes after extubation;
5. Postoperative pain CHEOPs scores were taken every 10 minutes during extubation and 30 min after extubation (the total score was less than 6 points and no pain was observed, and ≥10 points were treated with corresponding analgesia);
6. The use of anesthetic drugs (eg, pentazocine, propofol);
7. Changes of serum IL-6, TNF-α and folic acid concentrations before and after surgery.
8. Other adverse events during the recovery period (eg nausea and vomiting, bronchospasm, respiratory depression, etc.)
Огноо
| Сүүлд баталгаажуулсан: | 09/30/2019 |
| Эхлээд оруулсан: | 10/20/2019 |
| Тооцоолсон элсэлтийг оруулсан: | 10/21/2019 |
| Эхлээд нийтэлсэн: | 10/22/2019 |
| Сүүлийн шинэчлэлтийг оруулсан: | 10/22/2019 |
| Сүүлийн шинэчлэлтийг нийтэлсэн: | 10/24/2019 |
| Сургалтын бодит эхлэх огноо: | 12/29/2019 |
| Тооцоолсон анхан шатны ажил дуусах огноо: | 12/29/2021 |
| Судалгааны ажлыг дуусгах өдөр: | 12/29/2021 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Drug: Folic Acid
Drug: Placebo group
Үе шат
Arm Groups
| Гар | Хөндлөнгийн оролцоо / эмчилгээ |
|---|---|
| Experimental: Intervention group Intervention group: patients took 7 days of folic acid tablets before surgery (0.3mg/d for children aged 1-3, 0.4mg/d for children aged 4~5 years, dissolved in 20ml brown sugar water.) | |
| Experimental: Placebo group Placebo group: The patient received the same dose of brown sugar water for 7 days before surgery. Folic acid dose selection is based on the maximum daily intake of children（tolerable upper intake levels，UL） | Drug: Placebo group Patients in the placebo group received 20 ml of an aqueous solution of brown sugar with the same concentration as the intervention group on the 7th day before surgery. After the operation, the PAED scores were performed every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation. The PAED scores of all the children were performed by the same measurer. (The total score is 0~20 points, and the score ≥10 points is defined as the recovery period). |
Эрхийн шалгуур
| Суралцах боломжтой нас | 1 Year Хэнд 1 Year |
| Суралцах боломжтой хүйс | All |
| Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
| Шалгуур үзүүлэлтүүд | Inclusion Criteria: 1. ASA is graded from I to II 2. Children between the ages of 1 and 5 3. The weight is greater than or equal to 8.5kg 4. It is planned to undergo head and neck and maxillofacial surgery under general anesthesia Exclusion Criteria: 1. Children with a history of respiratory infection within 1 week 2. Children with congenital malformations such as congenital heart disease 3. Children with central nervous system diseases or those with mental disorders or mental disorders 4. Children with long-term use of sedative or analgesic drugs 5. Children with severe liver and kidney dysfunction 6. receiving folic acid supplementation therapy or taking related derivatives 7. Taking drugs that affect absorption in the past 1 month, such as sulfonamides, aspirin, etc. 8. Participated in other related clinical studies in the past 3 months |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. The incidence of sputum in children [8 days]
