Analgesics，OpioidNCT05386979
Multimodal Analgesic Management of Naborphine Combined With Opioid Free Anesthesia in OSA Patients Undergoing Bariatric Surgery
A study testing Opioid free anesthesia technology in people with Analgesics，Opioid and Bariatric Surgery, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Comparative study to explore the effect of opioid free anesthesia technology in perioperative analgesia management, clarify the effect of naborphine instead of opioids on perioperative analgesia management in morbid obesity patients with moderate and severe OSA, reduce related adverse events, and explore the latest… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesics，Opioid, Bariatric Surgery
- What is being tested?
- Opioid free anesthesia technology
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2022to 31 Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA grade I ~ III;
- Age from 18 - 65 years old;
- BMI ≥ 35kg / m2 in patients with OSA to undergo bariatric surgery； （4 provide written informed consent for participation.
Who cannot join
- Age < 18 years or age >65 years old;
- Pregnancy test was positive;
- Patients with a history of drug abuse or dependence on opioids;
- Patients with chronic pain or severe heart, lung, liver or nervous system diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Yongtao Sun
Jinan, Shandong, 250000
Yongtao Sun, doctor, 18660795201, sunyongtao1979@163.com
About this study
Official title: Multimodal Analgesic Management of Naborphine Combined With Opioid Free Under General Anesthesia in OSA Patients Undergoing Weight Loss Surgery Under the Concept of ERAS: a Prospective, Randomized, Parallel Controlled Study
Comparative study to explore the effect of opioid free anesthesia technology in perioperative analgesia management, clarify the effect of naborphine instead of opioids on perioperative analgesia management in morbid obesity patients with moderate and severe OSA, reduce related adverse events, and explore the latest clinical anesthetic drugs.
Read the detailed description
- The concept of enhanced recovery after surgery (ERAS) has been applied in the perioperative period of many operations. Reducing the dosage of opioids is an important part of the concept of ERAS.
- Opioid free anesthesia technology has been recognized in reducing nausea and vomiting, but whether it can meet the perioperative analgesic needs of patients undergoing bariatric surgery and obtain more clinical benefits still has no research supportment.
- This study is expected to clarify the clinical effect of opioid free anesthesia technology in perioperative analgesia management of morbid obesity patients with moderate and severe OSA, reduce adverse events, and explore the latest clinical anesthesia scheme.
- Conditions
- Analgesics，Opioid, Bariatric Surgery
- Being tested
- Opioid free anesthesia technology
- Keywords
- Opioid free anesthesia, Bariatric Surgery, ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid free anesthesia technologyProcedure or surgery
We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Opioid anesthesia group | Other | Anesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, sufentanil 0.3μg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and remifentanil 0.2-0.5 μg/kg·min to maintain anesthesia. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and sufentanil 10 μg will be given after surgery. For PCA, sufentanil 2μg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg. Receives: Procedure: Opioid free anesthesia technology |
| Opioid free anesthesia group | Experimental | Anesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, naborphine 0.2mg/kg，esketamine 0.3mg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and esketamine 0.3～0.5mg/kg·h. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and naborphine 0.2mg/kg will be given after surgery. For PCA, naborphine 2mg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg. Receives: Procedure: Opioid free anesthesia technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative NRS score
A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient or yes/no alternatives. The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain). A pain measurement list about quiet NRS score and cough NRS score at different postoperative time will be used.
Measured: Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
Secondary outcomes (11)
Dosage of remedial analgesics postoperatively
If the participant still feels severe pain after operation and needs additional analgesic drugs for treatment, we will record the type and dose of drugs used by the patient.
Measured: It takes about 24 hours.
Hemodynamic fluctuation
Hemodynamic fluctuation during perioperative period. The levels of SBP in mmHg, DBP in mmHg, MAP in mmHg and HR in times/minute in basic(T0), after induction(T1), preoperative(T2) and after establishing pneumoperitoneum(T3) 1h after the pneumoperitoneum(T4) and Immediately after operation(T5), Before(T6) and after(T7) extubation were recorded.
Measured: From the beginning of the general anesthesia induction to the time leaving PACU, it takes about 4 hours.
Ramsay scale
Ramsay scale is the most widely used sedation scoring standard in clinic, which is simple and practical. This scale has multiple advantages: it is reproducible, easily executed and has good applicability. This has made the scale the most widely used to assess level of sedation for procedures in pediatrics. It is divided into six levels(1-6): 1 shows patient is anxious and agitated or restless, or both; 2 shows patient is co-operative, oriented, and tranquil; 3 shows patient responds to commands only; 4 shows patient exhibits brisk response to light tactile stimuli or loudauditory stimulus; 5 shows patient exhibits sluggish response to light tactile stimuli or loud auditory stimulus; 6 shows patient exhibits no response.
Measured: Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
recovery time
From the time when the patient entered PACU to the time when the participant meets the standard of leaving the PACU.
Measured: It will take up to 1 hour or 2 hours.
The levels of C-reactive protein (CRP)
We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of C-reactive protein (mg/L).
Measured: It takes about 24 hours.
The levels of cortisol (COR).
We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of cortisol (nmol/L).
Measured: It takes about 24 hours.
The levels of blood glucose (BG)
We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of blood glucose (mmol/L).
Measured: It takes about 24 hours.
The levels of interleukin-6 (IL-6).
We will collect the participant's blood at the time before surgery(T0), after surgery(T1), and 24h after surgery(T2) to obtain the levels of IL-6 (pg/mL).
Measured: It takes about 24 hours.
Scores of 15-item Quality of Recovery (QoR-15) scale 24 hours postoperatively of participants.
The QoR-15 scale is a validated tool to assess the quality of postoperative recovery (QoR) from 0 to 150. The QoR was classified as excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) or poor (QoR-15 < 90).
Measured: One day after the surgery.
Rate of postoperative nausea and vomiting
Postoperative nausea and vomiting will be recorded if it happens.
Measured: It takes about 24 hours.
Acceptability of participants with laryngeal mask 24 hours after surgery.
One day after surgery, we will record the acceptability of laryngeal mask and the degree of postoperative pharyngeal pain of the participants. Acceptability of participants with laryngeal mask will be assessed by whether the participant was willing to receive laryngeal mask anesthesia again. Pharyngeal pain can be evaluated using the Numeric Pain Scale (NRS) pain numerical score. A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient or yes/no alternatives. The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain).
Measured: One day after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start15 May 2022 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Oct 2023 (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 Analgesics，OpioidStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Yongtao Sun, doctor, Principal investigator, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386979
- Sponsor's protocol ID
- YXLL-KY-2022(035)
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo Y, Chen L, Gao Z, Zhang M, Liu M, Gao X, Liu Y, Zhang X, Guo N, Sun Y, Wang Y. Is esketamine-based opioid-free anesthesia more superior for postoperative analgesia in obstructive sleep apnea patients undergoing bariatric surgery? A study protocol. Front Med (Lausanne). 2022 Nov 15;9:1039042. doi: 10.3389/fmed.2022.1039042. eCollection 2022.
PubMed 36457567
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analgesic Management of Naborphine Combined With Opioid Free Under General Anesthesia in OSA Patients Undergoing Weight Loss Surgery Under the Concept of ERAS: a Prospective, Randomized, Parallel Controlled Study
- ClinicalTrials.gov ID
- NCT05386979
- Acronym / sponsor ID
- YXLL-KY-2022(035)
- Conditions
- Analgesics，Opioid, Bariatric Surgery
- Keywords
- Opioid free anesthesia, Bariatric Surgery, ERAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 24 May 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.
Comparative study to explore the effect of opioid free anesthesia technology in perioperative analgesia management, clarify the effect of naborphine instead of opioids on perioperative analgesia management in morbid obesity patients with moderate and severe OSA, reduce related adverse events, and explore the latest clinical anesthetic drugs.
Detailed description
- The concept of enhanced recovery after surgery (ERAS) has been applied in the perioperative period of many operations. Reducing the dosage of opioids is an important part of the concept of ERAS.
- Opioid free anesthesia technology has been recognized in reducing nausea and vomiting, but whether it can meet the perioperative analgesic needs of patients undergoing bariatric surgery and obtain more clinical benefits still has no research supportment.
- This study is expected to clarify the clinical effect of opioid free anesthesia technology in perioperative analgesia management of morbid obesity patients with moderate and severe OSA, reduce adverse events, and explore the latest clinical anesthesia scheme.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid anesthesia group | Other | Procedure: Opioid free anesthesia technologyAnesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, sufentanil 0.3μg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and remifentanil 0.2-0.5 μg/kg·min to maintain anesthesia. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and sufentanil 10 μg will be given after surgery. For PCA, sufentanil 2μg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg. |
| Opioid free anesthesia group | Experimental | Procedure: Opioid free anesthesia technologyAnesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, naborphine 0.2mg/kg，esketamine 0.3mg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and esketamine 0.3～0.5mg/kg·h. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and naborphine 0.2mg/kg will be given after surgery. For PCA, naborphine 2mg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA grade I ~ III;
- Age from 18 - 65 years old;
- BMI ≥ 35kg / m2 in patients with OSA to undergo bariatric surgery； （4 provide written informed consent for participation.
Key exclusion criteria (4 listed)
- Age < 18 years or age >65 years old;
- Pregnancy test was positive;
- Patients with a history of drug abuse or dependence on opioids;
- Patients with chronic pain or severe heart, lung, liver or nervous system diseases
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 |
|---|---|---|
| Opioid free anesthesia technologyWe have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia. | Procedure or surgery | Opioid anesthesia group, Opioid free anesthesia group |
Primary outcome
postoperative NRS score
Time frame: Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient or yes/no alternatives. The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain). A pain measurement list about quiet NRS score and cough NRS score at different postoperative time will be used.
11 secondary outcomes
Dosage of remedial analgesics postoperatively
Time frame: It takes about 24 hours.
Hemodynamic fluctuation
Time frame: From the beginning of the general anesthesia induction to the time leaving PACU, it takes about 4 hours.
Ramsay scale
Time frame: Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
recovery time
Time frame: It will take up to 1 hour or 2 hours.
The levels of C-reactive protein (CRP)
Time frame: It takes about 24 hours.
The levels of cortisol (COR).
Time frame: It takes about 24 hours.
The levels of blood glucose (BG)
Time frame: It takes about 24 hours.
The levels of interleukin-6 (IL-6).
Time frame: It takes about 24 hours.
Scores of 15-item Quality of Recovery (QoR-15) scale 24 hours postoperatively of participants.
Time frame: One day after the surgery.
Rate of postoperative nausea and vomiting
Time frame: It takes about 24 hours.
Acceptability of participants with laryngeal mask 24 hours after surgery.
Time frame: One day after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 36457567Guo Y, Chen L, Gao Z, Zhang M, Liu M, Gao X, Liu Y, Zhang X, Guo N, Sun Y, Wang Y. Is esketamine-based opioid-free anesthesia more superior for postoperative analgesia in obstructive sleep apnea patients undergoing bariatric surgery? A study protocol. Front Med (Lausanne). 2022 Nov 15;9:1039042. doi: 10.3389/fmed.2022.1039042. 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.
Yongtao Sun, doctor principal investigator
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid free anesthesia technology in people with Analgesics，Opioid and Bariatric Surgery, run by Qianfoshan 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 4 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 24 May 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.
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 Yongtao Sun, doctor (18660795201, sunyongtao1979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative NRS score (time frame: Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.). 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 NCT05386979, 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 24 May 2022.