The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

NCT04048070 | Completed

• 1 other identifier: TR-ERAS
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis); Surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Hunger scores

  at 5 minutes before surgery start

• Self-rating Anxiety Scale

  at baseline and 72 hours after surgery

• thirst scores

  at 5 minutes before surgery start

• General comfort scores

  at baseline and 72 hours after surgery

• quality of sleeping

  at baseline and 72 hours after surgery

Study Arms (5)

ERAS with postoperative intravenous Flubiprofen Axetil

EXPERIMENTAL

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; Behavioral: Extended perioperative counseling; Behavioral: Shorter fasting food and water time before surgery

ERAS with analgesia pump

EXPERIMENTAL

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; Behavioral: Extended perioperative counseling; Behavioral: Shorter fasting food and water time before surgery

Traditional care with Flubiprofen Axetil

EXPERIMENTAL

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; Behavioral: Conventional perioperative counseling; Behavioral: Regular fasting food and water time before surgery

Traditional care with analgesia pump

EXPERIMENTAL

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; Behavioral: Conventional perioperative counseling; Behavioral: Regular fasting food and water time before surgery

traditional care without postoperative intravenous analgesia.

PLACEBO COMPARATOR

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; Behavioral: Regular fasting food and water time before surgery

Interventions

Flurbiprofen Axetil DRUG

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

ERAS with postoperative intravenous Flubiprofen Axetil; Traditional care with Flubiprofen Axetil

Sufentanil DRUG

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

ERAS with analgesia pump; Traditional care with analgesia pump

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.

ERAS with analgesia pump; ERAS with postoperative intravenous Flubiprofen Axetil

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

ERAS with analgesia pump; ERAS with postoperative intravenous Flubiprofen Axetil

Conventional perioperative counseling BEHAVIORAL

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

Traditional care with Flubiprofen Axetil; Traditional care with analgesia pump; traditional care without postoperative intravenous analgesia.

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.

Traditional care with Flubiprofen Axetil; Traditional care with analgesia pump; traditional care without postoperative intravenous analgesia.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has CRSwNP need endoscopic sinus surgery for treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Disease

Interventions

flurbiprofen axetil; Sufentanil

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vise president of BeijingTongren Hospital

Model Details: 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).

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 7, 2019
• Study Start: May 3, 2018
• Primary Completion: October 15, 2018
• Study Completion: October 30, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CN (1)