Back to resultsThe Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery
Primary Purpose
Chronic Rhinosinusitis (Diagnosis), Surgery
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Flurbiprofen Axetil
Sufentanil
Extended perioperative counseling
Shorter fasting food and water time before surgery
Conventional perioperative counseling
Regular fasting food and water time before surgery
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Rhinosinusitis (Diagnosis)
Eligibility Criteria
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.
Sites / Locations
- Beijing Tongren Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
ERAS with postoperative intravenous Flubiprofen Axetil
ERAS with analgesia pump
Traditional care with Flubiprofen Axetil
Traditional care with analgesia pump
traditional care without postoperative intravenous analgesia.
Arm 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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04048070
First Posted
August 5, 2019
Last Updated
August 10, 2019
Sponsor
Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04048070
Brief Title
The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery
Official Title
Benefits of Enhanced Recovery After Surgery in Patients Undergoing Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis), Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ERAS with postoperative intravenous Flubiprofen Axetil
Arm Type
Experimental
Arm 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.
Arm Title
ERAS with analgesia pump
Arm Type
Experimental
Arm 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.
Arm Title
Traditional care with Flubiprofen Axetil
Arm Type
Experimental
Arm 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.
Arm Title
Traditional care with analgesia pump
Arm Type
Experimental
Arm 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.
Arm Title
traditional care without postoperative intravenous analgesia.
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen Axetil
Intervention Description
One kind of NSAIDs, 200mg for 48 hours after surgery.
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery
Intervention Type
Behavioral
Intervention Name(s)
Extended perioperative counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Shorter fasting food and water time before surgery
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional perioperative counseling
Intervention Description
THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.
Intervention Type
Behavioral
Intervention Name(s)
Regular fasting food and water time before surgery
Intervention Description
The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.
Primary Outcome Measure Information:
Title
Pain management
Description
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.
Time Frame
at 2 hours after surgery
Title
Pain management
Description
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.
Time Frame
at 6 hours after surgery
Title
Pain management
Description
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.
Time Frame
at 24 hours after surgery
Title
Pain management
Description
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.
Time Frame
at 48 hours after surgery
Secondary Outcome Measure Information:
Title
Hunger scores
Description
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.
Time Frame
at 5 minutes before surgery start
Title
Self-rating Anxiety Scale
Description
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.
Time Frame
at baseline and 72 hours after surgery
Title
thirst scores
Description
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.
Time Frame
at 5 minutes before surgery start
Title
General comfort scores
Description
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.
Time Frame
at baseline and 72 hours after surgery
Title
quality of sleeping
Description
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.
Time Frame
at baseline and 72 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
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The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery
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