Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Butorphanol

Butorphanol 20ug/kg , anesthesia induction，Intravenous injection

Group Type EXPERIMENTAL

Butorphanol

Intervention Type DRUG

IV injection during induction

Placebo

Normal saline 5ml ， anesthesia induction，Intravenous injection

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

IV injection during induction

Interventions

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Butorphanol

IV injection during induction

Intervention Type DRUG

Placebos

IV injection during induction

Intervention Type DRUG

Other Intervention Names

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Normal saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No