Chronic Rhinosinusitis (Diagnosis)NCT04048070
The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery
A study testing Flurbiprofen Axetil, Sufentanil and Extended perioperative counseling in people with Chronic Rhinosinusitis (Diagnosis) and Surgery, run by Beijing Tongren Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis), Surgery
- What is being tested?
- Flurbiprofen Axetil, Sufentanil and Extended perioperative counseling
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2018to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has CRSwNP need endoscopic sinus surgery for treatment.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Rhinosinusitis (Diagnosis), Surgery
- Being tested
- Flurbiprofen Axetil, Sufentanil, Extended perioperative counseling, Shorter fasting food and water time before surgery, Conventional perioperative counseling
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flurbiprofen AxetilDrug
One kind of NSAIDs, 200mg for 48 hours after surgery.
SufentanilDrug
One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery
Extended perioperative counselingBehavioural
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 surgeryBehavioural
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 counselingBehavioural
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 surgeryBehavioural
The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Conventional perioperative counseling; Behavioral: Regular fasting food and water time before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 48 hours after surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline and 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start3 May 2018
- Primary completion15 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo Zhang, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048070
- Sponsor's protocol ID
- TR-ERAS
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Enhanced Recovery After Surgery in Patients Undergoing Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT04048070
- Acronym / sponsor ID
- TR-ERAS
- Conditions
- Chronic Rhinosinusitis (Diagnosis), Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- 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).
| Arm | Type | Receives |
|---|---|---|
| ERAS with postoperative intravenous Flubiprofen Axetil | Experimental | Drug: Flurbiprofen Axetil, Behavioral: Extended perioperative counseling, Behavioral: Shorter fasting food and water time before surgeryThe 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. |
| ERAS with analgesia pump | Experimental | Drug: Sufentanil, Behavioral: Extended perioperative counseling, Behavioral: Shorter fasting food and water time before surgeryThe 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. |
| Traditional care with Flubiprofen Axetil | Experimental | Drug: Flurbiprofen Axetil, Behavioral: Conventional perioperative counseling, Behavioral: Regular fasting food and water time before surgeryConventional 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. |
| Traditional care with analgesia pump | Experimental | Drug: Sufentanil, Behavioral: Conventional perioperative counseling, Behavioral: Regular fasting food and water time before surgeryConventional 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. |
| traditional care without postoperative intravenous analgesia. | Placebo comparator | Behavioral: Conventional perioperative counseling, Behavioral: Regular fasting food and water time before surgeryConventional 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patient has CRSwNP need endoscopic sinus surgery for treatment.
Key exclusion criteria (8 listed)
- age under 18 years
- pregnant
- ASA grade IV
- received oral or topical steroids within 4 weeks preceding surgery
- had previous ESS history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flurbiprofen AxetilOne kind of NSAIDs, 200mg for 48 hours after surgery. | Drug | ERAS with postoperative intravenous Flubiprofen Axetil, Traditional care with Flubiprofen Axetil |
| SufentanilOne kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery | Drug | ERAS with analgesia pump, Traditional care with analgesia pump |
| Extended perioperative counselingThe 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. | Behavioural | ERAS with analgesia pump, ERAS with postoperative intravenous Flubiprofen Axetil |
| Shorter fasting food and water time before surgeryThe 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 | Behavioural | ERAS with analgesia pump, ERAS with postoperative intravenous Flubiprofen Axetil |
| Conventional perioperative counselingTHe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know. | Behavioural | Traditional care with Flubiprofen Axetil, Traditional care with analgesia pump, traditional care without postoperative intravenous analgesia. |
| Regular fasting food and water time before surgeryThe stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time. | Behavioural | Traditional care with Flubiprofen Axetil, Traditional care with analgesia pump, traditional care without postoperative intravenous analgesia. |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Hunger scores
Time frame: at 5 minutes before surgery start
Self-rating Anxiety Scale
Time frame: at baseline and 72 hours after surgery
thirst scores
Time frame: at 5 minutes before surgery start
General comfort scores
Time frame: at baseline and 72 hours after surgery
quality of sleeping
Time frame: at baseline and 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flurbiprofen Axetil, Sufentanil and Extended perioperative counseling in people with Chronic Rhinosinusitis (Diagnosis) and Surgery, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain management (time frame: at 2 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.