NCT03398759

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2.9 years

First QC Date

January 3, 2018

Last Update Submit

March 8, 2020

Conditions

Agitation

Keywords

ButorphanolFunctional endoscopic sinus surgeryEmergence agitation

Outcome Measures

Primary Outcomes (1)

  • Emergence agitation incidence

    Emergence agitation incidence

    1 hour in the post anesthesia care unite(PACU)

Secondary Outcomes (3)

  • 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

Study Arms (2)

Butorphanol

EXPERIMENTAL

Butorphanol 20ug/kg , anesthesia induction，Intravenous injection

Drug: Butorphanol

Placebo

PLACEBO COMPARATOR

Normal saline 5ml ， anesthesia induction，Intravenous injection

Drug: Placebos

Interventions

ButorphanolDRUG

IV injection during induction

Butorphanol
PlacebosDRUG

IV injection during induction

Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

  • Zhang X, Qi S, Lin Z, Zhang Y, Dai W, Tian W, Tian J, Zheng L, Su D, Huai X. Pre-operative administration of butorphanol mitigates emergence agitation in patients undergoing functional endoscopic sinus surgery: A randomized controlled clinical trial. Front Psychiatry. 2023 Jan 17;13:1090149. doi: 10.3389/fpsyt.2022.1090149. eCollection 2022.

    PMID: 36733413DERIVED

MeSH Terms

Conditions

Psychomotor AgitationEmergence Delirium

Interventions

ButorphanolSaline Solution

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorDeliriumConfusionPostoperative ComplicationsPathologic ProcessesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Weifeng Yu, MD

    Anesthesiology Department Renji Hospital, Shanghai

    STUDY CHAIR

Central Study Contacts

Xiaorong Huai, MS

CONTACT

+8613818003683smile_huai@126.com

Diansan Su, MD

CONTACT

+8618616514088diansansu@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident physician

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 12, 2018

Study Start

February 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

CN(1)