Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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Emergence agitation is one of the common postoperative complications after functional endoscopic sinus surgery（FESS). The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus Surgery.

Detailed Description
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Butorphanol is a mixed agonist-antagonist opioid with strong κappa-receptor agonist and weak mu-receptor antagonist activity. It is commonly used for the management of cancer, postoperative, gynecologic, and obstetric pain. Additionally, Butorphanol has less respiratory depression and sedation effects, which make it may become a good medicine to alleviate the agitation. However, there is no clinical evidence to confirmation of such effectiveness of butorphanol. The objective of present study is to explore the effectiveness of butorphanol in the alleviation of emergence agitation in patients undergoing Functional Endoscopic Sinus Surgery.

Official Title
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Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery：a Randomized Control Double Blinded Clinical Trail

Conditions
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Agitation

Intervention / Treatment
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* Drug: Butorphanol
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 years,<=65years; height 150-180 cm; weight 55-80 kg; Signed the inform consent American Society of Anesthesiologists classification I to II Select to functional endoscopic sinus surgery Exclusion Criteria: Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis; Several audition or vision disorder; Unwillingness to comply with the protocol or procedures. Can not communicated with Chinese Mandarin Existing bradycardiac arrhythmia（Heart rate <60 bpm for any reasons） Existing gastrointestinal ulcer Existing urinary incontinence Existing asthma or chronic obstructive pulmonary disease Allegory to Butorphanol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butorphanol<br>Butorphanol 20ug/kg , anesthesia induction，Intravenous injection | Drug: Butorphanol<br>* IV injection during induction<br>|
| Placebo Comparator: Placebo<br>Normal saline 5ml ， anesthesia induction，Intravenous injection | Drug: Placebos<br>* IV injection during induction<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation incidence | Emergence agitation incidence | 1 hour in the post anesthesia care unite(PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAP | The mean arterial pressure | 1 hour in the post anesthesia care unite(PACU) | 
| HR | Heart rate | 1 hour in the post anesthesia care unite(PACU) | 
| quality of recovery -40 questionnaire | Measurement of quality of recovery with QoR-40 | 24h after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Butorphanol, Functional endoscopic sinus surgery, Emergence agitation