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临床试验/NCT04048070
NCT04048070已完成不适用

Benefits of Enhanced Recovery After Surgery in Patients Undergoing Endoscopic Sinus Surgery

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年5月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Pain management

研究概览

简要总结

Enhanced recovery after surgery (ERAS) protocols have been widely applied during perioperative periods for different diseases, there are few reports of ERAS in patients undergoing endoscopic sinus surgery (ESS). This study therefore aimed to evaluate the benefits of ERAS protocol compared to traditional care following ESS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient has CRSwNP need endoscopic sinus surgery for treatment.

排除标准

  • age under 18 years
  • ASA grade IV
  • received oral or topical steroids within 4 weeks preceding surgery
  • had previous ESS history
  • intolerant to NSAIDS
  • comorbidity of severe mental disease
  • not compliant with therapy.

研究组 & 干预措施

ERAS with postoperative intravenous Flubiprofen Axetil

Experimental

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Flurbiprofen Axetil (Drug)

ERAS with postoperative intravenous Flubiprofen Axetil

Experimental

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Extended perioperative counseling (Behavioral)

ERAS with postoperative intravenous Flubiprofen Axetil

Experimental

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Shorter fasting food and water time before surgery (Behavioral)

ERAS with analgesia pump

Experimental

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Sufentanil (Drug)

ERAS with analgesia pump

Experimental

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Extended perioperative counseling (Behavioral)

ERAS with analgesia pump

Experimental

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Shorter fasting food and water time before surgery (Behavioral)

Traditional care with Flubiprofen Axetil

Experimental

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Flurbiprofen Axetil (Drug)

Traditional care with Flubiprofen Axetil

Experimental

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Conventional perioperative counseling (Behavioral)

Traditional care with Flubiprofen Axetil

Experimental

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Regular fasting food and water time before surgery (Behavioral)

Traditional care with analgesia pump

Experimental

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Sufentanil (Drug)

Traditional care with analgesia pump

Experimental

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Conventional perioperative counseling (Behavioral)

Traditional care with analgesia pump

Experimental

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

干预措施: Regular fasting food and water time before surgery (Behavioral)

traditional care without postoperative intravenous analgesia.

Placebo Comparator

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Intravenous saline with necessary oral analgesic for postoperative pain management.

干预措施: Conventional perioperative counseling (Behavioral)

traditional care without postoperative intravenous analgesia.

Placebo Comparator

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Intravenous saline with necessary oral analgesic for postoperative pain management.

干预措施: Regular fasting food and water time before surgery (Behavioral)

结局指标

主要结局

Pain management

时间窗: at 48 hours after surgery

The pain scores after surgery were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable.

次要结局

  • Hunger scores(at 5 minutes before surgery start)
  • Self-rating Anxiety Scale(at baseline and 72 hours after surgery)
  • thirst scores(at 5 minutes before surgery start)
  • General comfort scores(at baseline and 72 hours after surgery)
  • quality of sleeping(at baseline and 72 hours after surgery)

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luo Zhang

vise president of BeijingTongren Hospital

Beijing Tongren Hospital

研究点 (1)

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