The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

Capital Medical University

Status: Completed

Conditions: Surgery; Chronic Rhinosinusitis (Diagnosis)

Treatments: Behavioral: Extended perioperative counseling; Behavioral: Shorter fasting food and water time before surgery; Drug: Sufentanil; Behavioral: Regular fasting food and water time before surgery; Drug: Flurbiprofen Axetil; Behavioral: Conventional perioperative counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04048070

TR-ERAS

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 5 patient groups, including a placebo group

ERAS with postoperative intravenous Flubiprofen Axetil

Experimental group

Description:

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.

Treatment:

Behavioral: Extended perioperative counseling

Drug: Flurbiprofen Axetil

Behavioral: Shorter fasting food and water time before surgery

ERAS with analgesia pump

Experimental group

Description:

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.

Treatment:

Behavioral: Extended perioperative counseling

Behavioral: Shorter fasting food and water time before surgery

Drug: Sufentanil

Traditional care with Flubiprofen Axetil

Experimental group

Description:

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.

Treatment:

Drug: Flurbiprofen Axetil

Behavioral: Regular fasting food and water time before surgery

Behavioral: Conventional perioperative counseling

Traditional care with analgesia pump

Experimental group

Description:

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.

Treatment:

Drug: Sufentanil

Behavioral: Regular fasting food and water time before surgery

Behavioral: Conventional perioperative counseling

traditional care without postoperative intravenous analgesia.

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Regular fasting food and water time before surgery

Behavioral: Conventional perioperative counseling