The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery
- Conditions
- Chronic Rhinosinusitis (Diagnosis)Surgery
- Interventions
- Behavioral: Extended perioperative counselingBehavioral: Conventional perioperative counselingBehavioral: Shorter fasting food and water time before surgeryBehavioral: Regular fasting food and water time before surgery
- Registration Number
- NCT04048070
- Lead Sponsor
- Beijing Tongren Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- The patient has CRSwNP need endoscopic sinus surgery for treatment.
- age under 18 years
- pregnant
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ERAS with postoperative intravenous Flubiprofen Axetil Flurbiprofen Axetil 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. ERAS with postoperative intravenous Flubiprofen Axetil Extended perioperative counseling 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. ERAS with postoperative intravenous Flubiprofen Axetil Shorter fasting food and water time before surgery 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. ERAS with analgesia pump Sufentanil 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. ERAS with analgesia pump Extended perioperative counseling 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. ERAS with analgesia pump Shorter fasting food and water time before surgery 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. Traditional care with Flubiprofen Axetil Flurbiprofen Axetil 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. Traditional care with Flubiprofen Axetil Conventional perioperative counseling 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. Traditional care with Flubiprofen Axetil Regular fasting food and water time before surgery 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. Traditional care with analgesia pump Sufentanil 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. Traditional care with analgesia pump Conventional perioperative counseling 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. Traditional care with analgesia pump Regular fasting food and water time before surgery 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. traditional care without postoperative intravenous analgesia. Conventional perioperative counseling 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. traditional care without postoperative intravenous analgesia. Regular fasting food and water time before surgery 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.
- Primary Outcome Measures
Name Time Method Pain management 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.
- Secondary Outcome Measures
Name Time Method Hunger scores at 5 minutes before surgery start The hunger scores before 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.
Self-rating Anxiety Scale at baseline and 72 hours after surgery The anxiety scale was measured by Self-rating Anxiety Scale (SAS) questionaire. The SAS questionaire contain 20 items and each item is range 1 to 4 points. The total scores is reported, which range 20 to 80 points and higher scores mean that more anxiety.
thirst scores at 5 minutes before surgery start The thirst scores before 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.
General comfort scores at baseline and 72 hours after surgery Kolcaba General Comfort Questionnaire (GCQ) was assessed to evaluate the quality of life of patients. The GCQ questionaire contain 28 items and each item is range 1 to 4 points. The total scores is reported, which range 28 to 112 points and higher scores mean that feel more comfort.
quality of sleeping at baseline and 72 hours after surgery Medical Outcomes Study Sleep Scale (MOS-SS) was assessed to evaluate the quality of sleep of patients. The MOS-SS questionaire contain 7 items, including sleep disturbance, snoring, awakening short of breath or with headache, sleep adequacy, daytime somnolence and amount of sleeping.
Trial Locations
- Locations (1)
Beijing Tongren Hospital
šØš³Beijing, Beijing, China