The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048070
• Other study ID #: TR-ERAS
• Status: Completed
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: August 2019
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 30, 2018
• Est. primary completion date: October 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis
• Surgery

Intervention

Drug:
• Flurbiprofen Axetil
One kind of NSAIDs, 200mg for 48 hours after surgery.
• Sufentanil
One kind of opioid drugs, 1.5µg/kg, and recorded the drug consumption after surgery

Behavioral:
• Extended perioperative counseling
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.
• Shorter fasting food and water time before surgery
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
• Conventional perioperative counseling
THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.
• Regular fasting food and water time before surgery
The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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