Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Not Applicable

• Conditions: Agitation
• Interventions: Drug: Placebos; Drug: Butorphanol

• Registration Number: NCT03398759
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-06
• Study First Posted: 2018-01-12
• Study Start: 2018-02-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-08
• Last Update Posted: 2020-03-10
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Normal saline 5ml ， anesthesia induction，Intravenous injection
Butorphanol	Butorphanol	Butorphanol 20ug/kg , anesthesia induction，Intravenous injection

Primary Outcome Measures

Name	Time	Method
Emergence agitation incidence	1 hour in the post anesthesia care unite(PACU)	Emergence agitation incidence

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine; 🇨🇳 Shanghai, Shanghai, China