Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Agitation
• Intervention / Treatment: Drug: Butorphanol; Drug: Placebos

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 Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaorong Huai, MS; Phone Number: +8613818003683; Email: smile_huai@126.com
• Study Contact Backup: Name: Diansan Su, MD; Phone Number: +8618616514088; Email: diansansu@yahoo.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
      • Contact: Xiaorong Huai, MS; Phone Number: +8613818003683; Email: smile_huai@126.com
      • Contact: Diansan Su, M.D., Ph.D; Phone Number: +8618616514088; Email: diansansu@yahoo.com
      • Principal Investigator: Xiaorong Huai, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Butorphanol; Butorphanol 20ug/kg , anesthesia induction，Intravenous injection	Drug: Butorphanol; IV injection during induction
Placebo Comparator: Placebo; Normal saline 5ml ， anesthesia induction，Intravenous injection	Drug: Placebos; IV injection during induction; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence agitation incidence	Emergence agitation incidence	1 hour in the post anesthesia care unite(PACU)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAP	The mean arterial pressure	1 hour in the post anesthesia care unite(PACU)
HR	Heart rate	1 hour in the post anesthesia care unite(PACU)
quality of recovery -40 questionnaire	Measurement of quality of recovery with QoR-40	24h after operation

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Weifeng Yu, MD, Anesthesiology Department Renji Hospital, Shanghai

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 6, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 8, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Butorphanol; Emergence agitation; Functional endoscopic sinus surgery
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Butorphanol
• Other Study ID Numbers: FNPA2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No