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The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04048070
Enrollment
55
Registered
2019-08-07
Start date
2018-05-03
Completion date
2018-10-30
Last updated
2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis (Diagnosis), Surgery

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.

Interventions

One kind of NSAIDs, 200mg for 48 hours after surgery.

DRUGSufentanil

One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery

BEHAVIORALExtended 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.

BEHAVIORALShorter 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

BEHAVIORALConventional perioperative counseling

THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.

BEHAVIORALRegular fasting food and water time before surgery

The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.

Sponsors

Beijing Tongren Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain managementat 2 hours after surgeryThe 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

MeasureTime frameDescription
Hunger scoresat 5 minutes before surgery startThe 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 Scaleat baseline and 72 hours after surgeryThe 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 scoresat 5 minutes before surgery startThe 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 scoresat baseline and 72 hours after surgeryKolcaba 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 sleepingat baseline and 72 hours after surgeryMedical 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026