Agitation
Conditions
Keywords
Butorphanol, Functional endoscopic sinus surgery, Emergence agitation
Brief summary
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
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.
Interventions
DRUGButorphanol
IV injection during induction
DRUGPlacebos
IV injection during induction
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 years,\<=65years; 2. height 150-180 cm; 3. weight 55-80 kg; 4. Signed the inform consent 5. American Society of Anesthesiologists classification I to II 6. Select to functional endoscopic sinus surgery
Exclusion criteria
1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis; 2. Several audition or vision disorder; 3. Unwillingness to comply with the protocol or procedures. 4. Can not communicated with Chinese Mandarin 5. Existing bradycardiac arrhythmia（Heart rate \<60 bpm for any reasons） 6. Existing gastrointestinal ulcer 7. Existing urinary incontinence 8. Existing asthma or chronic obstructive pulmonary disease 9. Allegory to Butorphanol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence agitation incidence | 1 hour in the post anesthesia care unite(PACU) | Emergence agitation incidence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MAP | 1 hour in the post anesthesia care unite(PACU) | The mean arterial pressure |
| HR | 1 hour in the post anesthesia care unite(PACU) | Heart rate |
| quality of recovery -40 questionnaire | 24h after operation | Measurement of quality of recovery with QoR-40 |
Countries
China
Contacts
Primary ContactXiaorong Huai, MS
Backup ContactDiansan Su, MD
Outcome results
None listed