Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Shanghai Jiao Tong University

Status: Unknown

Conditions: Agitation

Treatments: Drug: Placebos; Drug: Butorphanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03398759

FNPA2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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700 participants in 2 patient groups, including a placebo group

Butorphanol

Experimental group

Description:

Butorphanol 20ug/kg , anesthesia induction，Intravenous injection

Treatment:

Drug: Butorphanol

Placebo

Placebo Comparator group

Description:

Normal saline 5ml ， anesthesia induction，Intravenous injection

Treatment:

Drug: Placebos