Opioid-Free AnesthesiaNCT06305221
Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy
A study testing Opioid-free Analgesics (esketamine, dexmedetomidine) and Opioid Anesthetics (sufentanil and remifentanil) in people with Opioid-Free Anesthesia and Laparoscopic Sleeve Gastrectomy, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-Free Anesthesia, Laparoscopic Sleeve Gastrectomy, Postoperative Vomiting
- What is being tested?
- Opioid-free Analgesics (esketamine, dexmedetomidine) and Opioid Anesthetics (sufentanil and remifentanil)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2024to 31 Mar 2025
- 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
- Patients undergoing elective laparoscopic sleeve gastrectomy
- ASAA I or grade;
- volunteered in this trial and signed informed consent; ④ age 18-65 years; ⑤ BMI> 30kg / m2.
Who cannot join
- chronic pain;
- severe liver dysfunction (total bilirubin 2 mg dl-1);
- severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2);
- pregnancy or lactation;
- preoperative heart rate <50 beats / min, sick sinus syndrome, severe heart block; -dementia or significant neurological disorders (such as stroke, epilepsy, intracranial tumors, PD, etc.);
- history of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
bijia Song
Beijing
bijia Song, 18309845273, songbijia@163.com
About this study
The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain.
- Conditions
- Opioid-Free Anesthesia, Laparoscopic Sleeve Gastrectomy, Postoperative Vomiting, Postoperative Recovery
- Being tested
- Opioid-free Analgesics (esketamine, dexmedetomidine), Opioid Anesthetics (sufentanil and remifentanil)
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-free Analgesics (esketamine, dexmedetomidine)Drug
opioid free group: After infusion of a loading dose of dexmedetomidine, intravenous midazolam 2mg, propofol 2mg kg-1, esketamine 0.5 mg kg-1, rocuronium 0.6-1mg kg-1, and 3min after endotracheal intubation. Intravenous continuous infusion of propofol, esketamine and dexmedetomidine hydrochloride mixture (esketamine 50mg + dexmedetomidine hydrochloride 150 ug + 0.9% saline 50ml in the same 50ml syringe) 0.1ml kg-1 h-1-0.2 ml kg-1 h-1 (equivalent to esketamine 0.1-0.2mg kg-1 h-1; Dexmedetomidine hydrochloride 0.3-0.6 μ g kg-1 h-1) maintains a BIS value between 40-60, 10-20mg / time was added as appropriate.
Opioid Anesthetics (sufentanil and remifentanil)Drug
Intravenous midazolam 2mg, propofol 2mg kg-1, sufentanyl 0.3-0.5 μ g kg-1, rocuronium 0.6-1mg kg-1,3min before endotracheal intubation. After successful endotracheal intubation, continuous intravenous infusion of propofol and remifentanil was started to maintain BIS values between 40-60, and rocuronium 10-20mg / time as appropriate. After the start of surgery, 10-20 μ g of sufentanil was added according to blood pressure and heart rate. At the end of the operation, 5mg and 50mg were injected before the end of the operation, and propofol and remifentanil were stopped at the end of the operation
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free group | Experimental | Not described Receives: Drug: Opioid-free Analgesics (esketamine, dexmedetomidine) |
| Opioid group | Active comparator | Not described Receives: Drug: Opioid Anesthetics (sufentanil and remifentanil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
15-item recovery quality scale score 48 hours after surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
Measured: 48 hours after surgery
15-item recovery quality scale score 24 hours before surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
Measured: 24 hours before surgery
15-item recovery quality scale score 24 hours after surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
Measured: 24 hours after surgery
Secondary outcomes (9)
Dosage of postoperative analgesics
record dosage of postoperative analgesics
Measured: 48 hours after surgery
Duration of until postoperative PACU Aldrete score> 9 points
Anesthesia recovery was defined by Aldrete's recovery score (RS, 0-10), assessed following postanesthesia care unit (PACU) arrival, with RS ≥9 considered discharge eligible
Measured: up to 30 min after surgery at postoperative recovery room
anesthesia-related complication
record anesthesia-related complication
Measured: 24 hours after surgery
time to first exhaust gas after surgery
Measured: 24 hours after surgery
time of first postoperative mobilization
Measured: 24 hours after surgery
Overall benefit of analgesic score satisfaction in pain treatment
To calculate the OBAS score, compute the sum of scores in items 1-6 and add '4-score in item 7'. Note that a low score indicates high benefit. test overall benefit of analgesic score satisfaction in pain treatment at 6, 24, 48 hours after surgery
Measured: 6, 24, 48 hours after surgery
Acute pain numeric rating scale score
The pain 0-10 classification is the numerical classification (NRS) of subjective assessment, with 0 painless pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, and 10 severe pain. test acute pain numeric rating scale score at 6, 24, 48 hours after surgery
Measured: 6, 24, 48 hours after surgery
Rhodes Index of Nausea, Vomiting, and Retching
Rhodes Index of Nausea, Vomiting, and Retching, an 8-item questionnaire, to measure the incidence and severity of nausea, vomiting, and retching At each timepoint, a total Rhodes score was calculated from the sum of the 8 RINVR questions. Total Rhodes scores were compared at 6 different timepoints as well as overall across all 6 time points. record Nausea and vomiting, the Rhodes index score
Measured: one night before surgery
Rhodes Index of Nausea, Vomiting, and Retching
Rhodes Index of Nausea, Vomiting, and Retching , an 8-item questionnaire, to measure the incidence and severity of nausea, vomiting, and retching At each timepoint, a total Rhodes score was calculated from the sum of the 8 RINVR questions. Total Rhodes scores were compared at 6 different timepoints as well as overall across all 6 time points. record Nausea and vomiting, the Rhodes index score. record Nausea and vomiting, the Rhodes index score
Measured: 6, 24, 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start9 Mar 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Free AnesthesiaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bijia Song, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305221
- Sponsor's protocol ID
- opioid-free analgesia
- Status last verified
- May 2024
- First submitted
- 3 Mar 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06305221
- Acronym / sponsor ID
- opioid-free analgesia
- Conditions
- Opioid-Free Anesthesia, Laparoscopic Sleeve Gastrectomy, Postoperative Vomiting, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 12 Mar 2024 (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.
The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-free group | Experimental | Drug: Opioid-free Analgesics (esketamine, dexmedetomidine) |
| Opioid group | Active comparator | Drug: Opioid Anesthetics (sufentanil and remifentanil) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective laparoscopic sleeve gastrectomy
Key exclusion criteria (6 listed)
- chronic pain;
- severe liver dysfunction (total bilirubin 2 mg dl-1);
- severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2);
- pregnancy or lactation;
- preoperative heart rate <50 beats / min, sick sinus syndrome, severe heart block; -dementia or significant neurological disorders (such as stroke, epilepsy, intracranial tumors, PD, etc.);
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 Analgesics (esketamine, dexmedetomidine)opioid free group: After infusion of a loading dose of dexmedetomidine, intravenous midazolam 2mg, propofol 2mg kg-1, esketamine 0.5 mg kg-1, rocuronium 0.6-1mg kg-1, and 3min after endotracheal intubation. Intravenous continuous infusion of propofol, esketamine and dexmedetomidine hydrochloride mixture (esketamine 50mg + dexmedetomidine hydrochloride 150 ug + 0.9% saline 50ml in the same 50ml syringe) 0.1ml kg-1 h-1-0.2 ml kg-1 h-1 (equivalent to esketamine 0.1-0.2mg kg-1 h-1; Dexmedetomidine hydrochloride 0.3-0.6 μ g kg-1 h-1) maintains a BIS value between 40-60, 10-20mg / time was added as appropriate. | Drug | Opioid-free group |
| Opioid Anesthetics (sufentanil and remifentanil)Intravenous midazolam 2mg, propofol 2mg kg-1, sufentanyl 0.3-0.5 μ g kg-1, rocuronium 0.6-1mg kg-1,3min before endotracheal intubation. After successful endotracheal intubation, continuous intravenous infusion of propofol and remifentanil was started to maintain BIS values between 40-60, and rocuronium 10-20mg / time as appropriate. After the start of surgery, 10-20 μ g of sufentanil was added according to blood pressure and heart rate. At the end of the operation, 5mg and 50mg were injected before the end of the operation, and propofol and remifentanil were stopped at the end of the operation | Drug | Opioid group |
Primary outcome
15-item recovery quality scale score 48 hours after surgery
Time frame: 48 hours after surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
15-item recovery quality scale score 24 hours before surgery
Time frame: 24 hours before surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
15-item recovery quality scale score 24 hours after surgery
Time frame: 24 hours after surgery
The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery
9 secondary outcomes
Dosage of postoperative analgesics
Time frame: 48 hours after surgery
Duration of until postoperative PACU Aldrete score> 9 points
Time frame: up to 30 min after surgery at postoperative recovery room
anesthesia-related complication
Time frame: 24 hours after surgery
time to first exhaust gas after surgery
Time frame: 24 hours after surgery
time of first postoperative mobilization
Time frame: 24 hours after surgery
Overall benefit of analgesic score satisfaction in pain treatment
Time frame: 6, 24, 48 hours after surgery
Acute pain numeric rating scale score
Time frame: 6, 24, 48 hours after surgery
Rhodes Index of Nausea, Vomiting, and Retching
Time frame: one night before surgery
Rhodes Index of Nausea, Vomiting, and Retching
Time frame: 6, 24, 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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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.
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 Analgesics (esketamine, dexmedetomidine) and Opioid Anesthetics (sufentanil and remifentanil) in people with Opioid-Free Anesthesia and Laparoscopic Sleeve Gastrectomy, run by Beijing Friendship 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: status not confirmed, as of the sponsor's last update on 9 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15-item recovery quality scale score 48 hours after surgery (time frame: 48 hours after surgery). 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?
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 9 May 2024.