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Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Primary Purpose

Agitation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Butorphanol

Placebos

About this trial

This is an interventional prevention trial for Agitation focused on measuring Butorphanol, Functional endoscopic sinus surgery, Emergence agitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age >=18 years,<=65years;
height 150-180 cm;
weight 55-80 kg;
Signed the inform consent
American Society of Anesthesiologists classification I to II
Select to functional endoscopic sinus surgery

Exclusion Criteria:

Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
Several audition or vision disorder;
Unwillingness to comply with the protocol or procedures.
Can not communicated with Chinese Mandarin
Existing bradycardiac arrhythmia（Heart rate <60 bpm for any reasons）
Existing gastrointestinal ulcer
Existing urinary incontinence
Existing asthma or chronic obstructive pulmonary disease
Allegory to Butorphanol

Sites / Locations

Renji Hospital, Shanghai Jiao Tong University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Butorphanol

Placebo

Arm Description

Butorphanol 20ug/kg , anesthesia induction，Intravenous injection

Normal saline 5ml ， anesthesia induction，Intravenous injection

Outcomes

Primary Outcome Measures

Emergence agitation incidence

Secondary Outcome Measures

MAP

The mean arterial pressure

Heart rate

quality of recovery -40 questionnaire

Measurement of quality of recovery with QoR-40

Full Information

NCT ID

NCT03398759

First Posted

January 3, 2018

Last Updated

March 8, 2020

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03398759

Brief Title

Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Agitation

Keywords

Butorphanol, Functional endoscopic sinus surgery, Emergence agitation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Butorphanol

Arm Type

Experimental

Arm Description

Butorphanol 20ug/kg , anesthesia induction，Intravenous injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Normal saline 5ml ， anesthesia induction，Intravenous injection

Intervention Type

Drug

Intervention Name(s)

Butorphanol

Intervention Description

IV injection during induction

Intervention Type

Drug

Intervention Name(s)

Placebos

Other Intervention Name(s)

Normal saline

Intervention Description

IV injection during induction

Primary Outcome Measure Information:

Title

Emergence agitation incidence

Description

Emergence agitation incidence

Time Frame

1 hour in the post anesthesia care unite(PACU)

Secondary Outcome Measure Information:

Title

MAP

Description

The mean arterial pressure

Time Frame

1 hour in the post anesthesia care unite(PACU)

Title

Description

Heart rate

Time Frame

1 hour in the post anesthesia care unite(PACU)

Title

quality of recovery -40 questionnaire

Description

Measurement of quality of recovery with QoR-40

Time Frame

24h after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age >=18 years,<=65years; height 150-180 cm; weight 55-80 kg; Signed the inform consent American Society of Anesthesiologists classification I to II Select to functional endoscopic sinus surgery Exclusion Criteria: Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis; Several audition or vision disorder; Unwillingness to comply with the protocol or procedures. Can not communicated with Chinese Mandarin Existing bradycardiac arrhythmia（Heart rate <60 bpm for any reasons） Existing gastrointestinal ulcer Existing urinary incontinence Existing asthma or chronic obstructive pulmonary disease Allegory to Butorphanol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaorong Huai, MS

Phone

+8613818003683

smile_huai@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Diansan Su, MD

Phone

+8618616514088

diansansu@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weifeng Yu, MD

Organizational Affiliation

Anesthesiology Department Renji Hospital, Shanghai

Official's Role

Study Chair

Facility Information:

Facility Name

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaorong Huai, MS

Phone

+8613818003683

smile_huai@126.com

First Name & Middle Initial & Last Name & Degree

Diansan Su, M.D., Ph.D

Phone

+8618616514088

diansansu@yahoo.com

First Name & Middle Initial & Last Name & Degree

Xiaorong Huai, MS

12. IPD Sharing Statement

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Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

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