Opioid UsePhase 4NCT04396587

Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone

A Phase 4 study testing Sufentanil, Hydromorphone and Oxycodone in people with Opioid Use, run by Peking University People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women only
Conditions the study is for: Opioid Use
What is being tested?: Sufentanil, Hydromorphone and Oxycodone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteChina
Study dates: 20 May 2020to 1 Jun 2023
Phase: Phase 4
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 50 years
Women only
No healthy volunteers
Adult

Who may be able to join

American Society of Anesthesiologists GradeⅠ-II;
Patients undergo low-risk elective surgery for benign diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, breast operation, thyroid operation, etc) ;
Aged 18-45 years;
Body Mass Index 18-25kg/m2, weight 40-65 kilograms;
Agreed to participate in the research

Who cannot join

Difficult airway;
upper respiratory tract infection within 2 weeks;
history of allergy or long-term use of propofol and opioids;
self-rating anxiety scale before operation indicates anxiety;
pregnancy or lactation.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University People's Hospital
Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in Female Patients Before Anesthesia Induction

This study aimed to investigate Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in female patients. Methods: A total of 60 patients were randomly divided into 4 groups, with 20 patients in each group. Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) ,saline(10ml)was administered before anesthesia induction. Bispectral Index (BIS), Respiratory rate(RR), other non-analgesic effects at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.

Conditions: Opioid Use
Being tested: Sufentanil, Hydromorphone, Oxycodone, normal Saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SufentanilDrug
Sufentanil(0.1μg/kg) was administered before anesthesia induction.
HydromorphoneDrug
Hydromorphone(20μg/kg)was administered before anesthesia induction.
OxycodoneDrug
Oxycodone(60μg/kg) was administered before anesthesia induction.
normal SalineDrug
normal saline 10ml

Study groups in NCT04396587
Study group	Role	What they receive
Sufentanil	Experimental	Sufentanil(0.1μg/kg) Receives: Drug: Sufentanil
Hydromorphone	Experimental	Hydromorphone(20μg/kg） Receives: Drug: Hydromorphone
Oxycodone	Experimental	Oxycodone(60μg/kg) Receives: Drug: Oxycodone
normal saline	Placebo comparator	10ml Receives: Drug: normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Respiratory rate
Number of breaths per minute
Measured: 20 minutes after administration
Bispectral Index
bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
Measured: 20 minutes after administration
dizziness
a temporary feeling that your sense of balance is not good and that you may fall down
Measured: 20 minutes after administration

Secondary outcomes (4)

itch
itch
Measured: 20 minutes after administration
nausea or vomiting
nausea or vomiting
Measured: 20 minutes after administration
drowsiness
drowsiness
Measured: 20 minutes after administration
sweating
sweating
Measured: 20 minutes after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 20201 Jun 2023

First posted20 May 2020
Study start20 May 2020
Primary completion1 Jan 2023
Study completion1 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Opioid UseStudies of the same condition, open and under way.
More trials run by Peking University People's 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04396587
Sponsor's protocol ID: NAESHO
Status last verified: May 2024
First submitted: 16 May 2020
Last updated: 30 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Use trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in Female Patients Before Anesthesia Induction
ClinicalTrials.gov ID: NCT04396587
Acronym / sponsor ID: NAESHO
Conditions: Opioid Use
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Peking University People's HospitalUniversity, hospital or other
Study start: 20 May 2020 (actual)
Primary completion: 1 Jan 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 20 May 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Sufentanil	Experimental	Drug: SufentanilSufentanil(0.1μg/kg)
Hydromorphone	Experimental	Drug: HydromorphoneHydromorphone(20μg/kg）
Oxycodone	Experimental	Drug: OxycodoneOxycodone(60μg/kg)
normal saline	Placebo comparator	Drug: normal Saline10ml

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

American Society of Anesthesiologists GradeⅠ-II;
Patients undergo low-risk elective surgery for benign diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, breast operation, thyroid operation, etc) ;
Aged 18-45 years;
Body Mass Index 18-25kg/m2, weight 40-65 kilograms;
Agreed to participate in the research

Key exclusion criteria (5 listed)

Difficult airway;
upper respiratory tract infection within 2 weeks;
history of allergy or long-term use of propofol and opioids;
self-rating anxiety scale before operation indicates anxiety;
pregnancy or lactation.

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
SufentanilSufentanil(0.1μg/kg) was administered before anesthesia induction.	Drug	Sufentanil
HydromorphoneHydromorphone(20μg/kg)was administered before anesthesia induction.	Drug	Hydromorphone
OxycodoneOxycodone(60μg/kg) was administered before anesthesia induction.	Drug	Oxycodone
normal Salinenormal saline 10ml	Drug	normal saline

Primary outcome

Respiratory rate
Time frame: 20 minutes after administration
Number of breaths per minute
Bispectral Index
Time frame: 20 minutes after administration
bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
dizziness
Time frame: 20 minutes after administration
a temporary feeling that your sense of balance is not good and that you may fall down

4 secondary outcomes

itch
Time frame: 20 minutes after administration
nausea or vomiting
Time frame: 20 minutes after administration
drowsiness
Time frame: 20 minutes after administration
sweating
Time frame: 20 minutes after administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
Individual participant dataSharing planned: No

Related trials for Opioid Use

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
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Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sufentanil, Hydromorphone and Oxycodone in people with Opioid Use, run by Peking University People's 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 30 May 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory rate (time frame: 20 minutes after administration). The study lists 3 primary outcomes in all. 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 NCT04396587.

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 30 May 2024.