The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

NCT ID: NCT04048070

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2018-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Rhinosinusitis (Diagnosis) Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Flurbiprofen Axetil

Intervention Type DRUG

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

Extended perioperative counseling

Intervention Type 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.

Shorter fasting food and water time before surgery

Intervention Type 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

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.

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

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

Extended perioperative counseling

Intervention Type 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.

Shorter fasting food and water time before surgery

Intervention Type 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

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.

Group Type EXPERIMENTAL

Flurbiprofen Axetil

Intervention Type DRUG

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

Conventional perioperative counseling

Intervention Type BEHAVIORAL

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 surgery

Intervention Type BEHAVIORAL

The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.

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.

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

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

Conventional perioperative counseling

Intervention Type BEHAVIORAL

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 surgery

Intervention Type BEHAVIORAL

The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.

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.

Group Type PLACEBO_COMPARATOR

Conventional perioperative counseling

Intervention Type BEHAVIORAL

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 surgery

Intervention Type BEHAVIORAL

The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flurbiprofen Axetil

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

Intervention Type DRUG

Sufentanil

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

Intervention Type DRUG

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.

Intervention Type 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

Intervention Type BEHAVIORAL

Conventional perioperative counseling

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luo Zhang

vise president of BeijingTongren Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TR-ERAS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Global Sinus Surgery Registry
NCT02347943 TERMINATED
Topical Irrigation Therapy for CRS
NCT02630472 TERMINATED PHASE1/PHASE2