The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Rhinosinusitis (Diagnosis), Surgery

Intervention / Treatment
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* Drug: Flurbiprofen Axetil
* Drug: Sufentanil
* Behavioral: Extended perioperative counseling
* Behavioral: Shorter fasting food and water time before surgery
* Behavioral: Conventional perioperative counseling
* Behavioral: Regular fasting food and water time before surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has CRSwNP need endoscopic sinus surgery for treatment. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with chronic rhinosinusitis undergoing ESS were prospectively assigned to one of five groups; ERAS groups with postoperative intravenous Flubiprofen Axetil or analgesia pump, traditional care with Flubiprofen Axetil or analgesia pump (NERAS groups), or traditional care without postoperative intravenous analgesia group (control).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS with postoperative intravenous Flubiprofen Axetil<br>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. | Drug: Flurbiprofen Axetil<br>* One kind of NSAIDs, 200mg for 48 hours after surgery.<br>Behavioral: Extended perioperative counseling<br>* The extended perioperative counseling contained additional information, including surgery procedures, importance of medicine treatment and medical help to relieve depression and anxiety about disease during peri-operation period.<br>Behavioral: Shorter fasting food and water time before surgery<br>* The patients in ERAS group were required to fast food for 6 to 8 hours and provided 12.6% maltodextrin carbohydrate supplement beverage for 2 hours before surgery<br>|
| Experimental: ERAS with analgesia pump<br>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. | Drug: Sufentanil<br>* One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery<br>Behavioral: Extended perioperative counseling<br>* The extended perioperative counseling contained additional information, including surgery procedures, importance of medicine treatment and medical help to relieve depression and anxiety about disease during peri-operation period.<br>Behavioral: Shorter fasting food and water time before surgery<br>* The patients in ERAS group were required to fast food for 6 to 8 hours and provided 12.6% maltodextrin carbohydrate supplement beverage for 2 hours before surgery<br>|
| Experimental: Traditional care with Flubiprofen Axetil<br>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. | Drug: Flurbiprofen Axetil<br>* One kind of NSAIDs, 200mg for 48 hours after surgery.<br>Behavioral: Conventional perioperative counseling<br>* THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.<br>Behavioral: Regular fasting food and water time before surgery<br>* The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.<br>|
| Experimental: Traditional care with analgesia pump<br>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. | Drug: Sufentanil<br>* One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery<br>Behavioral: Conventional perioperative counseling<br>* THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.<br>Behavioral: Regular fasting food and water time before surgery<br>* The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.<br>|
| Placebo Comparator: traditional care without postoperative intravenous analgesia.<br>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. | Behavioral: Conventional perioperative counseling<br>* THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.<br>Behavioral: Regular fasting food and water time before surgery<br>* The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain management | 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. | at 2 hours after surgery | 
| Pain management | 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. | at 6 hours after surgery | 
| Pain management | 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. | at 24 hours after surgery | 
| Pain management | 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. | at 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hunger scores | 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. | at 5 minutes before surgery start | 
| Self-rating Anxiety Scale | 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. | at baseline and 72 hours after surgery | 
| thirst scores | 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. | at 5 minutes before surgery start | 
| General comfort scores | 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. | at baseline and 72 hours after surgery | 
| quality of sleeping | 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. | at baseline and 72 hours after surgery |