The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

Benefits of Enhanced Recovery After Surgery in Patients Undergoing 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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (Diagnosis); Surgery
• Intervention / Treatment: Drug: Flurbiprofen Axetil; Behavioral: Extended perioperative counseling; Behavioral: Shorter fasting food and water time before surgery; Drug: Sufentanil; Behavioral: Conventional perioperative counseling; Behavioral: Regular fasting food and water time before surgery

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS with postoperative intravenous Flubiprofen Axetil; 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; One kind of NSAIDs, 200mg for 48 hours 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.; Behavioral: 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
Experimental: ERAS with analgesia pump; 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.	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.; Behavioral: 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; Drug: Sufentanil; One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery
Experimental: Traditional care with Flubiprofen Axetil; 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; One kind of NSAIDs, 200mg for 48 hours after surgery.; Behavioral: Conventional perioperative counseling; THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.; Behavioral: 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.
Experimental: Traditional care with analgesia pump; 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; One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery; Behavioral: Conventional perioperative counseling; THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.; Behavioral: 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.
Placebo Comparator: traditional care without postoperative intravenous analgesia.; 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; THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 10, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil; Flurbiprofen; Flurbiprofen axetil
• Other Study ID Numbers: TR-ERAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No