Cardiac Surgery PatientsNCT06437886
High-dose Opioid Versus Opioid-sparing Anaesthesia in Cardiac Surgery
A study testing opioid-sparing protocol in people with Cardiac Surgery Patients, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
BACKGROUND In cardiac surgery, high-dose opioid contributes to adverse events associated with poor postoperative outcomes. There is growing evidence that nerve block-based multi-modal anesthesia protocols may reduce intraoperative opioid consumption without compromising analgesia management and consequently improve… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Cardiac Surgery Patients
- What is being tested?
- opioid-sparing protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to 22 Jul 2024
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult patients aged 45 to 70 years, awaiting elective cardiac surgery, and American Society of Anaesthesiologists physical status classes II or III were eligible.
Who cannot join
- contraindications to punctual or local anesthetic drugs, a history of chronic pain or chronic opioid use, and an inability to communicate or refuse to enroll.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Recovery After Cardiac Surgery A Randomised Controlled Trial of High-dose Opioid Versus Opioid-sparing Anaesthesia
BACKGROUND In cardiac surgery, high-dose opioid contributes to adverse events associated with poor postoperative outcomes. There is growing evidence that nerve block-based multi-modal anesthesia protocols may reduce intraoperative opioid consumption without compromising analgesia management and consequently improve patient's early postoperative recovery.
OBJECTIVE To determine whether opioid-sparing anaesthesia based on ultrasound-guided nerve block could improve early postoperative recovery after cardiac surgery.
Read more
DESIGN A randomised controlled trial. SETTING A tertiary hospital. PATIENTS Eighty patients aged 45 to 70 years undergoing cardiac surgery were enrolled. Key exclusion criteria included contraindication to interventions or drugs and a history of chronic pain or chronic opioid use.
INTERVENTIONS Eligible patients were randomised at a 1:1 ratio to receive either opioid-sparing anaesthesia based on ultrasound-guided nerve block (intervention group) or opioid-based anaesthesia (control group).
MAIN OUTCOME MEASURES The primary outcome was the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24h after surgery. Secondary outcomes included QoR-15 at 72h after surgery, postoperative pain score, the incidence of postoperative adverse events and chronic pain. Other outcomes included endotracheal intubation duration, length of hospitalization, and hospital costs.
- Conditions
- Cardiac Surgery Patients
- Being tested
- opioid-sparing protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid-sparing protocolOther
Patients in the OSA group was administrated with 0.5 to 1 mcg·kg-1 sufentanil and received PIFB combined with RSB after anesthetic induction. Patients in the control group were recommended to receive 2 to 3 mcg·kg-1 opioid-based sufentanil. PIFB was conducted at the T2 to T5 levels under ultrasound guidance. Each side received 20 ml 0.3% ropivacaine containing 2.5 mg dexamethasone. Bilateral RSB was conducted after the PIFB and the needle was inserted into the plane between the rectus abdominal muscle and its posterior sheath using an in-plane approach. After verifying needle placement, 15 ml 0.3% ropivacaine containing 2.5 mg dexamethasone was delivered to each side. In the control group, patients received no procedure and were administrated with traditional anesthetic protocol. Patients received continuous intravenous sufentanil (50 to 100 mg) and tropisetron (5 to 10 mg) at 2 ml·h-1 for the first 48 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia | Experimental | Not described Receives: Other: opioid-sparing protocol |
| high-dose opiod traditional anesthesia | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-15 at 24h
the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24h after surgery
Measured: at 24 hours after surgery
Secondary outcomes (4)
QoR-15 at 72h
the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 72h after surgery
Measured: QoR-15 at 72 hours after surgery
Number rating score (NRS)
Postoperatvie pain was evaluated using a number rating score (NRS) (0 = no pain, 10 = worst pain possible).
Measured: NRS at 24 hours and 72 hours after surgery
postoperative adverse events
postoperative adverse events included major adverse cardiovascular events (MACCEs), moderate to severe acute kidney injury (AKI), moderate to severe acute liver injury, reintubation, and postoperative nausea and vomiting (PONV).
Measured: during hospitalization, an average of 2 weeks, assessed up to 30 days
chronic pain
persistent postoperative pain lasting beyond 3 months
Measured: at 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start22 Apr 2024
- Primary completion22 Jul 2024 (estimated)
- Study completion22 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery PatientsStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Fuxia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437886
- Sponsor's protocol ID
- 2024-2323
- Status last verified
- Jul 2024
- First submitted
- 22 May 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data availuable by sending email to corresponding authors
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Recovery After Cardiac Surgery A Randomised Controlled Trial of High-dose Opioid Versus Opioid-sparing Anaesthesia
- ClinicalTrials.gov ID
- NCT06437886
- Acronym / sponsor ID
- 2024-2323
- Conditions
- Cardiac Surgery Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 22 Jul 2024 (estimated)
- Study completion
- 22 Jul 2024 (estimated)
- First posted
- 31 May 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.
BACKGROUND In cardiac surgery, high-dose opioid contributes to adverse events associated with poor postoperative outcomes. There is growing evidence that nerve block-based multi-modal anesthesia protocols may reduce intraoperative opioid consumption without compromising analgesia management and consequently improve patient's early postoperative recovery.
OBJECTIVE To determine whether opioid-sparing anaesthesia based on ultrasound-guided nerve block could improve early postoperative recovery after cardiac surgery.
DESIGN A randomised controlled trial. SETTING A tertiary hospital. PATIENTS Eighty patients aged 45 to 70 years undergoing cardiac surgery were enrolled. Key exclusion criteria included contraindication to interventions or drugs and a history of chronic pain or chronic opioid use.
INTERVENTIONS Eligible patients were randomised at a 1:1 ratio to receive either opioid-sparing anaesthesia based on ultrasound-guided nerve block (intervention group) or opioid-based anaesthesia (control group).
MAIN OUTCOME MEASURES The primary outcome was the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24h after surgery. Secondary outcomes included QoR-15 at 72h after surgery, postoperative pain score, the incidence of postoperative adverse events and chronic pain. Other outcomes included endotracheal intubation duration, length of hospitalization, and hospital costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia | Experimental | Other: opioid-sparing protocol |
| high-dose opiod traditional anesthesia | No intervention | – |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female adult patients aged 45 to 70 years, awaiting elective cardiac surgery, and American Society of Anaesthesiologists physical status classes II or III were eligible.
Key exclusion criteria (1 listed)
- contraindications to punctual or local anesthetic drugs, a history of chronic pain or chronic opioid use, and an inability to communicate or refuse to enroll.
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-sparing protocolPatients in the OSA group was administrated with 0.5 to 1 mcg·kg-1 sufentanil and received PIFB combined with RSB after anesthetic induction. Patients in the control group were recommended to receive 2 to 3 mcg·kg-1 opioid-based sufentanil. PIFB was conducted at the T2 to T5 levels under ultrasound guidance. Each side received 20 ml 0.3% ropivacaine containing 2.5 mg dexamethasone. Bilateral RSB was conducted after the PIFB and the needle was inserted into the plane between the rectus abdominal muscle and its posterior sheath using an in-plane approach. After verifying needle placement, 15 ml 0.3% ropivacaine containing 2.5 mg dexamethasone was delivered to each side. In the control group, patients received no procedure and were administrated with traditional anesthetic protocol. Patients received continuous intravenous sufentanil (50 to 100 mg) and tropisetron (5 to 10 mg) at 2 ml·h-1 for the first 48 hours after surgery. | Other | pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia |
Primary outcome
QoR-15 at 24h
Time frame: at 24 hours after surgery
the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24h after surgery
4 secondary outcomes
QoR-15 at 72h
Time frame: QoR-15 at 72 hours after surgery
Number rating score (NRS)
Time frame: NRS at 24 hours and 72 hours after surgery
postoperative adverse events
Time frame: during hospitalization, an average of 2 weeks, assessed up to 30 days
chronic pain
Time frame: at 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No. Data availuable by sending email to corresponding authors
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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.
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 study testing opioid-sparing protocol in people with Cardiac Surgery Patients, run by Chinese Academy of Medical Sciences, Fuwai 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: status not confirmed, as of the sponsor's last update on 30 Jul 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?
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?
QoR-15 at 24h (time frame: at 24 hours after surgery). 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 30 Jul 2024.