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Completed

NCT Number: NCT04048070

The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

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.

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Key information

Conditions

Chronic Rhinosinusitis (Diagnosis) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flurbiprofen Axetil

Drug

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

Sufentanil

Drug

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

Extended perioperative counseling

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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

Primary outcomes

  1. Pain management

    Time frame: at 2 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.

  2. Pain management

    Time frame: at 6 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.

  3. Pain management

    Time frame: at 24 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.

  4. Pain management

    Time frame: 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 outcomes

  1. Hunger scores

    Time frame: 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.

  2. Self-rating Anxiety Scale

    Time frame: 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.

  3. thirst scores

    Time frame: 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.

  4. General comfort scores

    Time frame: 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.

  5. quality of sleeping

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2019
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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