ClinicalTrials.gg
Status unknownNCT03398759Updated Mar 10, 2020

Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery

An interventional study of Butorphanol and Placebos in Agitation, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-10.

Primary conditionEmergence DeliriumRegistry: Psychomotor AgitationReclassifiedWhy we changed it
Registry
Psychomotor Agitation — the first condition term the registry derived for this study.
ClinicalTrials.gg
Emergence Delirium
Why
  1. The registry often attaches Psychomotor Agitation to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's title name Emergence Delirium.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by RenJi Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 12 studies in Emergence Delirium by RenJi Hospital — 4 open to participants now, 4 under way, 1 of them phase 3. Emergence Delirium · RenJi Hospital.

Planned enrollment
4th of 11
700 · median 200
Started
2018
with 1 other
No phase
5 of 12
1 open now
Registered
3rd of 12
by date

Among the 12 studies in Emergence Delirium by RenJi Hospital, this one is the 4th largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2018, is one of 5 with no phase, and was the 3rd registered.

Emergence Delirium

752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

Browse Emergence Delirium studies →

Open to participants now

4 of the 12 studies in Emergence Delirium by RenJi Hospital are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 143 Emergence Delirium studies recruiting now, 79 (55%) set no upper age limit and 44 (31%) stop at 75 or younger; 34 take children under 18; 24 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Emergence Delirium by RenJi Hospital, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Agitation

Browse trials for

Keywords

  • Butorphanol
  • Functional endoscopic sinus surgery
  • Emergence agitation
04

In context

Emergence Delirium Reclassified

752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.

This study's planned enrollment of 700 is above the median of 120 across 466 interventional studies indexed under Emergence Delirium.

Browse Emergence Delirium studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.

Compared within Emergence Delirium, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychomotor Agitation. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age >=18 years,\<=65years;
  2. height 150-180 cm;
  3. weight 55-80 kg;
  4. Signed the inform consent
  5. classification I to II
  6. Select to functional endoscopic sinus surgery

Exclusion criteria

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
  9. Allegory to Butorphanol
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

06

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
700 participants (estimated)

Study arms

  • Experimental
    Butorphanol

    Butorphanol 20ug/kg , anesthesia induction,Intravenous injection

    Drug: Butorphanol

  • Placebo comparator
    Placebo

    Normal saline 5ml , anesthesia induction,Intravenous injection

    Drug: Placebos

Interventions

  • IV injection during induction

  • DrugPlacebos

    IV injection during induction

    Also known as: Normal saline

07

What researchers measure

Primary outcomes

  1. Emergence agitation incidence

    Emergence agitation incidence

    Time frame: 1 hour in the post anesthesia care unite(PACU)

Secondary outcomes

  1. MAP

    The mean arterial pressure

    Time frame: 1 hour in the post anesthesia care unite(PACU)

  2. HR

    Heart rate

    Time frame: 1 hour in the post anesthesia care unite(PACU)

  3. quality of recovery -40 questionnaire

    Measurement of quality of recovery with QoR-40

    Time frame: 24h after operation

08

Study locations

1 of 1 sites recruiting
  • Renji Hospital, Shanghai Jiao Tong University, School of Medicine
    Shanghai, Shanghai 200127, China
    Recruiting
    • Xiaorong Huai, MS · Contactsmile_huai@126.com · +8613818003683
    • Diansan Su, M.D., Ph.D · Contactdiansansu@yahoo.com · +8618616514088
    • Xiaorong Huai, MS · Principal investigator
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Dec 2020, 34 months after the start.

Of 186 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 34 months is above that.

Counting every sponsor, half of 186 studies reached it within 19 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2018
First posted
Jan 12, 2018
StartActual
Feb 1, 2018
Primary completionEst.
Dec 31, 2020
CompletionEst.
Dec 31, 2020
Last update
Mar 10, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03398759
Lead sponsor
RenJi Hospital
Responsible party
Xiaorong Huai (resident physician, RenJi Hospital) — Principal investigator
First posted
Jan 12, 2018
Start date
Feb 1, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Mar 10, 2020

Study contacts

Xiaorong Huai, MS
Contact
smile_huai@126.com
+8613818003683
Diansan Su, MD
Contact
diansansu@yahoo.com
+8618616514088
Weifeng Yu, MD
study chair · Anesthesiology Department Renji Hospital, Shanghai

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Butorphanol

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