Long-term-opioid-free AnesthesiaNCT05548465
Long-term-opioid-free Anesthesia in Anterior Cervical Surgery
A study testing Remifentanil Hydrochloride and Sufentanil Citrate in people with Long-term-opioid-free Anesthesia, run by West China Hospital at 1 site in China.
Trial summary
We design this randomized controlled trial to explore the safety and efficacy of the long-term-opioid-free anesthesia in anterior cervical surgery, to reduce the dosage of perioperative long-acting opioids and promoting patients'rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Long-term-opioid-free Anesthesia
- What is being tested?
- Remifentanil Hydrochloride and Sufentanil Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2022to 31 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing anterior cervical surgery., sign the "informed consent form"
- Age above 18 years old
- ASA Ⅰ-Ⅲ.
Who cannot join
- Pregnant or lactating women.
- Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc
- Allergic to the materials or drugs used in this study.
- Patients with current/previous gastrointestinal bleeding and gastric ulcers;
- Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness.
- Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: The Safety and Efficacy of Long-term-opioid-free Anesthesia in Anterior Cervical Surgery: a Prospective Randomized Controlled Trial
We design this randomized controlled trial to explore the safety and efficacy of the long-term-opioid-free anesthesia in anterior cervical surgery, to reduce the dosage of perioperative long-acting opioids and promoting patients'rehabilitation.
- Conditions
- Long-term-opioid-free Anesthesia
- Being tested
- Remifentanil Hydrochloride, Sufentanil Citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil HydrochlorideDrug
Subjects will receive remifentanil anesthesia for operative analgesia.
Sufentanil CitrateDrug
Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Long-term-opioid-free anesthesia group. | Experimental | Not described Receives: Drug: Remifentanil Hydrochloride |
| Long-term-opioid anesthesia group. | Active comparator | Not described Receives: Drug: Sufentanil Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative numerical rating scales (NRS) at rest.
Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h after surgery.
Measured: Up to 48 hours after operation.
Secondary outcomes (9)
Incidence of post operative nausea and vomiting (PONV).
The proportion of subjects who experienced PONV.
Measured: Up to 30 days after operation.
Postoperative NRS on movement.
Postoperative NRS pain score on movement, up to 48hr.
Measured: Up to 48 hours after operation.
Postoperative complications.
Incidence of postoperative adverse reactions and complications.
Measured: Up to 30 days after operation.
Incidence of intraoperative adverse events.
Measured: Intraoperative .
Postoperative recovery of cervical spine function
Japanese Orthopaedic Association Scores.(JOA scores).
Measured: Up to 48 hours after operation.
Analgesic medication use before discharge。
Measured: Up to 48 hours after operation.
Length of stay (LOS) in hospital
Time frame from the day of hospital admission to discharge from the hospital (unit: days).
Measured: Up to 30 days after operation.
Postoperative LOS
Time frame from the day of operation to discharge from the hospital (unit: days).
Measured: Up to 30 days after operation.
Total in-hospital cost.
Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.
Measured: Up to 30 days after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start26 Sep 2022
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term-opioid-free AnesthesiaStudies of the same condition, open and under way.
- More trials run by West China 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548465
- Sponsor's protocol ID
- WCH20220916
- Status last verified
- May 2024
- First submitted
- 16 Sep 2022
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Long-term-opioid-free Anesthesia in Anterior Cervical Surgery: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05548465
- Acronym / sponsor ID
- WCH20220916
- Conditions
- Long-term-opioid-free Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Sep 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.
We design this randomized controlled trial to explore the safety and efficacy of the long-term-opioid-free anesthesia in anterior cervical surgery, to reduce the dosage of perioperative long-acting opioids and promoting patients'rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term-opioid-free anesthesia group. | Experimental | Drug: Remifentanil Hydrochloride |
| Long-term-opioid anesthesia group. | Active comparator | Drug: Sufentanil Citrate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing anterior cervical surgery., sign the "informed consent form"
- Age above 18 years old
- ASA Ⅰ-Ⅲ.
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc
- Allergic to the materials or drugs used in this study.
- Patients with current/previous gastrointestinal bleeding and gastric ulcers;
- Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness.
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 |
|---|---|---|
| Remifentanil HydrochlorideSubjects will receive remifentanil anesthesia for operative analgesia. | Drug | Long-term-opioid-free anesthesia group. |
| Sufentanil CitrateSubjects will receive sufentanil and remifentanil anesthesia for operative analgesia. | Drug | Long-term-opioid anesthesia group. |
Primary outcome
Postoperative numerical rating scales (NRS) at rest.
Time frame: Up to 48 hours after operation.
Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h after surgery.
9 secondary outcomes
Incidence of post operative nausea and vomiting (PONV).
Time frame: Up to 30 days after operation.
Postoperative NRS on movement.
Time frame: Up to 48 hours after operation.
Postoperative complications.
Time frame: Up to 30 days after operation.
Incidence of intraoperative adverse events.
Time frame: Intraoperative .
Postoperative recovery of cervical spine function
Time frame: Up to 48 hours after operation.
Analgesic medication use before discharge。
Time frame: Up to 48 hours after operation.
Length of stay (LOS) in hospital
Time frame: Up to 30 days after operation.
Postoperative LOS
Time frame: Up to 30 days after operation.
Total in-hospital cost.
Time frame: Up to 30 days 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 7 May 2024.
- Individual participant dataSharing planned: No
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.
Ren Liao, M.D principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil Hydrochloride and Sufentanil Citrate in people with Long-term-opioid-free Anesthesia, run by West China 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 3 inclusion and 6 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 7 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. 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?
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?
Postoperative numerical rating scales (NRS) at rest. (time frame: Up to 48 hours after operation.). 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 7 May 2024.