Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398759
• Other study ID #: FNPA2017
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: RenJi Hospital
• Contact: Xiaorong Huai, MS
• Phone: +8613818003683
• Email: smile_huai[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Butorphanol
IV injection during induction
• Placebos
IV injection during induction

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence agitation incidence	Emergence agitation incidence	1 hour in the post anesthesia care unite(PACU)
Secondary	MAP	The mean arterial pressure	1 hour in the post anesthesia care unite(PACU)
Secondary	HR	Heart rate	1 hour in the post anesthesia care unite(PACU)
Secondary	quality of recovery -40 questionnaire	Measurement of quality of recovery with QoR-40	24h after operation