Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Last updated: March 8, 2020
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Manic Disorders

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT03398759
FNPA2017
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Existing cerebral disease, or have a history of neurological and psychiatric diseasesincluding 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

Study Design

Total Participants: 700
Study Start date:
February 01, 2018
Estimated Completion Date:
December 31, 2020

Study 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.

Connect with a study center

  • Renji Hospital, Shanghai Jiao Tong University, School of Medicine

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

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