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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butorphanol | Experimental | Butorphanol 20ug/kg , anesthesia induction,Intravenous injection |
|
| Placebo | Placebo Comparator | Normal saline 5ml , anesthesia induction,Intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butorphanol | Drug | IV injection during induction |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Emergence agitation incidence | Emergence agitation incidence | 1 hour in the post anesthesia care unite(PACU) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaorong Huai, MS | Contact | +8613818003683 | smile_huai@126.com | |
| Diansan Su, MD | Contact | +8618616514088 | diansansu@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Weifeng Yu, MD | Anesthesiology Department Renji Hospital, Shanghai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, Shanghai Jiao Tong University, School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36733413 | Derived | Zhang X, Qi S, Lin Z, Zhang Y, Dai W, Tian W, Tian J, Zheng L, Su D, Huai X. Pre-operative administration of butorphanol mitigates emergence agitation in patients undergoing functional endoscopic sinus surgery: A randomized controlled clinical trial. Front Psychiatry. 2023 Jan 17;13:1090149. doi: 10.3389/fpsyt.2022.1090149. eCollection 2022. |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D002077 | Butorphanol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Drug |
IV injection during induction |
|
|
| quality of recovery -40 questionnaire | Measurement of quality of recovery with QoR-40 | 24h after operation |
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003693 | Delirium |
| D003221 | Confusion |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |