AgitationNCT03398759
Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery
A study testing Butorphanol in people with Agitation, run by RenJi Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Agitation
- What is being tested?
- Butorphanol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Existing urinary incontinence
- Existing asthma or chronic obstructive pulmonary disease
- Allegory to Butorphanol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
Xiaorong Huai, MS, +8613818003683, smile_huai@126.com
Diansan Su, M.D., Ph.D, +8618616514088, diansansu@yahoo.com
About this study
Official title: Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery：a Randomized Control Double Blinded Clinical Trail
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.
- Conditions
- Agitation
- Being tested
- Butorphanol, Placebos
- Keywords
- Butorphanol, Functional endoscopic sinus surgery, Emergence agitation
- Medical subject headings
- Psychomotor Agitation, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButorphanolDrug
IV injection during induction
PlacebosDrug
Also called Normal saline
IV injection during induction
| Study group | Role | What they receive |
|---|---|---|
| Butorphanol | Experimental | Butorphanol 20ug/kg , anesthesia induction，Intravenous injection Receives: Drug: Butorphanol |
| Placebo | Placebo comparator | Normal saline 5ml ， anesthesia induction，Intravenous injection Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation incidence
Emergence agitation incidence
Measured: 1 hour in the post anesthesia care unite(PACU)
Secondary outcomes (3)
MAP
The mean arterial pressure
Measured: 1 hour in the post anesthesia care unite(PACU)
HR
Heart rate
Measured: 1 hour in the post anesthesia care unite(PACU)
quality of recovery -40 questionnaire
Measurement of quality of recovery with QoR-40
Measured: 24h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Feb 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Huai, RenJi Hospital
- Investigators
- Weifeng Yu, MD, Study chair, Anesthesiology Department Renji Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398759
- Sponsor's protocol ID
- FNPA2017
- Status last verified
- Mar 2020
- First submitted
- 3 Jan 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36733413
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Butorphanol Mitigate Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery：a Randomized Control Double Blinded Clinical Trail
- ClinicalTrials.gov ID
- NCT03398759
- Acronym / sponsor ID
- FNPA2017
- Conditions
- Agitation
- Keywords
- Butorphanol, Functional endoscopic sinus surgery, Emergence agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butorphanol | Experimental | Drug: ButorphanolButorphanol 20ug/kg , anesthesia induction，Intravenous injection |
| Placebo | Placebo comparator | Drug: PlacebosNormal saline 5ml ， anesthesia induction，Intravenous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >=18 years,<=65years;
- height 150-180 cm;
- weight 55-80 kg;
- Signed the inform consent
- American Society of Anesthesiologists classification I to II
Key exclusion criteria (9 listed)
- 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）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ButorphanolIV injection during induction | Drug | Butorphanol |
| PlacebosAlso: Normal salineIV injection during induction | Drug | Placebo |
Primary outcome
Emergence agitation incidence
Time frame: 1 hour in the post anesthesia care unite(PACU)
Emergence agitation incidence
3 secondary outcomes
MAP
Time frame: 1 hour in the post anesthesia care unite(PACU)
HR
Time frame: 1 hour in the post anesthesia care unite(PACU)
quality of recovery -40 questionnaire
Time frame: 24h after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 36733413Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weifeng Yu, MD study chair
Anesthesiology Department Renji Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butorphanol in people with Agitation, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaorong Huai, MS (+8613818003683, smile_huai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence agitation incidence (time frame: 1 hour in the post anesthesia care unite(PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03398759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.