Gastrointestinal SurgeryPhase 3NCT05576675
Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery
A Phase 3 study testing sufentanil + nalbuphine, Sufentanil and hydromorphone + nalbuphine in people with Gastrointestinal Surgery, run by Xijing Hospital at 1 site in China.
Trial summary
Objective To evaluate the effect of patient-controlled intravenous analgesia combined with different opioid receptors for gastrointestinal surgery. Methods A total of 4342 patients who underwent gastrointestinal postoperative analgesia in the first affiliated Hospital of Air Force military Medical University from May… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Surgery
- What is being tested?
- sufentanil + nalbuphine, Sufentanil and hydromorphone + nalbuphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,342 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Mar 2022
- Phase
- Phase 3
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years ,there is no gender limit，ASA grade Ⅰ-Ⅱ
Who cannot join
- BMI > 35 kg/m2, history of upper abdominal surgery, history of analgesic or hormone use before operation, history of depression or chronic pain before operation, infection before operation and ICU after operation
Trial locations and contacts
1 site in 1 country.
About this study
Objective To evaluate the effect of patient-controlled intravenous analgesia combined with different opioid receptors for gastrointestinal surgery. Methods A total of 4342 patients who underwent gastrointestinal postoperative analgesia in the first affiliated Hospital of Air Force military Medical University from May 2018 to March 2022 were collected retrospectively. The patient-controlled intravenous analgesia regimen in this study was composed of different opioid receptor drugs：sufentanil combined with nalbuphine group (SN group) and Hydromorphone combined with nalbuphine group (HN group) and single opioid receptor group: sufentanil group (S group). SN group ,HN group and S group were treated with sufentanil 100 μ g + nalbuphine 40 mg, hydromorphone 10 mg+ nalbuphine 40 mg, sufentanil 200 μ g, diluted to 100 ml, background dose 1 ml/h, PCA dose 0.5 ml, locking time 10 min. The demographic data of the three groups were collected, the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected, evaluate the analgesic effect of combination of different opioid receptor drugs and single opioid receptor drugs in PCIA after gastrointestinal surgery.
Read the detailed description
Control group：S group Test group：SN group and HN group Observation index：the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions（drowsiness, nausea and vomiting, respiratory depression, dizziness） at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected
- Conditions
- Gastrointestinal Surgery
- Being tested
- sufentanil + nalbuphine, Sufentanil, hydromorphone + nalbuphine
- Keywords
- patient-controlled intravenous analgesia, gastrointestinal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanil + nalbuphineDrug
sufentanil 100 μ g + nalbuphine 40 mg
SufentanilDrug
sufentanil 200 μ g
hydromorphone + nalbuphineDrug
hydromorphone 10 mg+ nalbuphine 40 mg
| Study group | Role | What they receive |
|---|---|---|
| SN group | Experimental | sufentanil 100 μ g + nalbuphine 40 mg Receives: Drug: sufentanil + nalbuphine |
| HN group | Experimental | hydromorphone 10 mg+ nalbuphine 40 mg Receives: Drug: hydromorphone + nalbuphine |
| S group | Experimental | sufentanil 200 μ g, Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of insufficient static and dynamic analgesia dynamic analgesia
VAS ≥ 4
Measured: 24 hours after operation
the incidence of insufficient static and dynamic analgesia dynamic analgesia
VAS ≥ 4
Measured: 48 hours after operation
Secondary outcomes (2)
the incidence of adverse reactions
dizziness, nausea and vomiting
Measured: 24 hours after operation
the incidence of adverse reactions
dizziness, nausea and vomiting
Measured: 48 hours 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 Oct 2022
- Study start1 May 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SurgeryStudies of the same condition, open and under way.
- More trials run by Xijing 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan LI, Study chair, The First Affiliated Hospital of the Air Force Medical Universtiyjing LIN, Study chair, The First Affiliated Hospital of the Air Force Medical Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576675
- Sponsor's protocol ID
- xijingHospital
- Status last verified
- Aug 2022
- First submitted
- 1 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT05576675
- Acronym / sponsor ID
- xijingHospital
- Conditions
- Gastrointestinal Surgery
- Keywords
- patient-controlled intravenous analgesia, gastrointestinal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,342 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 12 Oct 2022 (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.
Objective To evaluate the effect of patient-controlled intravenous analgesia combined with different opioid receptors for gastrointestinal surgery. Methods A total of 4342 patients who underwent gastrointestinal postoperative analgesia in the first affiliated Hospital of Air Force military Medical University from May 2018 to March 2022 were collected retrospectively. The patient-controlled intravenous analgesia regimen in this study was composed of different opioid receptor drugs：sufentanil combined with nalbuphine group (SN group) and Hydromorphone combined with nalbuphine group (HN group) and single opioid receptor group: sufentanil group (S group). SN group ,HN group and S group were treated with sufentanil 100 μ g + nalbuphine 40 mg, hydromorphone 10 mg+ nalbuphine 40 mg, sufentanil 200 μ g, diluted to 100 ml, background dose 1 ml/h, PCA dose 0.5 ml, locking time 10 min. The demographic data of the three groups were collected, the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected, evaluate the analgesic effect of combination of different opioid receptor drugs and single opioid receptor drugs in PCIA after gastrointestinal surgery.
Detailed description
Control group：S group Test group：SN group and HN group Observation index：the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions（drowsiness, nausea and vomiting, respiratory depression, dizziness） at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SN group | Experimental | Drug: sufentanil + nalbuphinesufentanil 100 μ g + nalbuphine 40 mg |
| HN group | Experimental | Drug: hydromorphone + nalbuphinehydromorphone 10 mg+ nalbuphine 40 mg |
| S group | Experimental | Drug: Sufentanilsufentanil 200 μ g, |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75 years ,there is no gender limit，ASA grade Ⅰ-Ⅱ
Key exclusion criteria (1 listed)
- BMI > 35 kg/m2, history of upper abdominal surgery, history of analgesic or hormone use before operation, history of depression or chronic pain before operation, infection before operation and ICU after operation
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 |
|---|---|---|
| sufentanil + nalbuphinesufentanil 100 μ g + nalbuphine 40 mg | Drug | SN group |
| Sufentanilsufentanil 200 μ g | Drug | S group |
| hydromorphone + nalbuphinehydromorphone 10 mg+ nalbuphine 40 mg | Drug | HN group |
Primary outcome
the incidence of insufficient static and dynamic analgesia dynamic analgesia
Time frame: 24 hours after operation
VAS ≥ 4
the incidence of insufficient static and dynamic analgesia dynamic analgesia
Time frame: 48 hours after operation
VAS ≥ 4
2 secondary outcomes
the incidence of adverse reactions
Time frame: 24 hours after operation
the incidence of adverse reactions
Time frame: 48 hours after operation
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 12 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Yan LI study chair
The First Affiliated Hospital of the Air Force Medical Universtiy
jing LIN study chair
The First Affiliated Hospital of the Air Force Medical Universtiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sufentanil + nalbuphine, Sufentanil and hydromorphone + nalbuphine in people with Gastrointestinal Surgery, run by Xijing 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 1 inclusion and 1 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 12 Oct 2022. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the incidence of insufficient static and dynamic analgesia dynamic analgesia (time frame: 24 hours after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2022.