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

Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery



Sponsors

Lead Sponsor



Source

RenJi Hospital

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2017-10-01

Completion Date

2018-12-31

Primary Completion Date

2018-12-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

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

Secondary Outcome

Measure

Time Frame

MAP
1 hour in the post anesthesia care unite(PACU)
HR
1 hour in the post anesthesia care unite(PACU)
quality of recovery -40 questionnaire
24h after operation

Enrollment

700

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Butorphanol IV injection

Arm Group Label

Butorphanol

Placebo



Eligibility

Criteria

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

Gender

All

Minimum Age

18 Years

Maximum Age

65 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Weifeng Yu, MD
Study Chair
Anesthesiology Department Renji Hospital, Shanghai

Overall Contact

Last Name

Xiaorong Huai, MS

Phone

+8613818003683

Email



Location

Facility

Status

Contact

Investigator

Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai Shanghai 200127 China
Recruiting
Last Name: Xiaorong Huai, MS
Phone: +8613818003683
Email: [email protected]
Last Name: Xiaorong Huai, MS
Role: Principal Investigator

Location Countries

Country

China


Verification Date

2018-01-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

RenJi Hospital

Investigator Full Name

Xiaorong Huai

Investigator Title

resident physician


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Intervention Browse

Mesh Term

Butorphanol


Arm Group

Arm Group Label

Butorphanol

Arm Group Type

Experimental

Description

Butorphanol 20ug/kg , anesthesia induction,Intravenous injection


Arm Group Label

Placebo

Arm Group Type

Placebo Comparator

Description

Normal saline 5ml , anesthesia induction,Intravenous injection



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Diansan Su, MD

Phone

+8618616514088

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Prevention

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Study First Submitted

January 3, 2018

Study First Submitted Qc

January 6, 2018

Study First Posted

January 12, 2018

Last Update Submitted

January 16, 2018

Last Update Submitted Qc

January 16, 2018

Last Update Posted

January 17, 2018


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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