Postoperative PainPhase 4NCT04837170
Safety and Efficacy Evaluation of S (+) - Ketamine in Adults
A Phase 4 study testing Conventional therapy + S (+)-Ketamine and Conventional therapy in people with Postoperative Pain and Adults, run by Chinese PLA General Hospital.
Trial summary
A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in adults in perioperative settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Adults, Anesthesia
- What is being tested?
- Conventional therapy + S (+)-Ketamine and Conventional therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 30 Jun 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years old;
- 2. Scheduled for elective digestive tract surgery, gynecological surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or body surface surgery (thyroid surgery or breast surgery), head and neck surgery;
- 3. ASA score Ⅰ～Ⅲ;
- 4. The informed consent form was signed by the patients.
Who cannot join
- 1. The expected length of hospital stay of the patient is less than 48h;
- 2. Patients expected to be admitted to the ICU after surgery;
- 3. Patients expected to return to the ward with tracheal catheter after surgery;
- 4. Be allergic to S (+) - ketamine;
- 5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
- 6. Patients with a history of severe cardiovascular disease (congestive heart failure, severe angina attack, or unstable angina or myocardial infarction within 6 months);
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- 7. Patients during pregnancy or lactation;
- 8. Patients with MMSE score <18 points;
- 9. Patients with any of the following contraindications of S (+) - ketamine:
- Patients with risk of serious rise of blood pressure or intracranial pressure;
- Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;
- Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);
- Patients with untreated or undertreated hyperthyroidism.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy Evaluation of S（+）-Ketamine for Postoperative Acute Pain in Adults in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial
A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in adults in perioperative settings.
Read the detailed description
Patients often suffer acute pain after operation ，which may affect the recovery. Opioid such as morphine is the most commonly analgesic drugs, but opioid has many obviously adverse reactions ,for example respiratory depression,circulation inhibition,tolerance, addiction, nausea, vomiting, pruritus, etc. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese patients undergoing surgery.
Objective:Evaluate the efficacy and safety of S (+) - ketamine on acute perioperative pain for chinese adult patients,and look for the best dosage, mode of administration, timing, and compatibility ,as well explore the effect of S (+) - ketamine on postoperative delirium,anxiety ,depression and cognitive dysfunction.
- Conditions
- Postoperative Pain, Adults, Anesthesia
- Being tested
- Conventional therapy + S (+)-Ketamine, Conventional therapy
- Keywords
- S-ketamine,Esketamine,S (+) - ketamine, Acute Pain, Depression, Anxiety, Delirium, Hyperalgesia
- Medical subject headings
- Pain, Postoperative, Acute Pain, Depression, Anxiety Disorders, Delirium, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapy + S (+)-KetamineDrug
Also called Conventional therapy + S-ketamine, Conventional therapy + Esketamine
Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction,maintenance or postoperative analgesia.
Also called Routine treatment
Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine.
| Study group | Role | What they receive |
|---|---|---|
| S (+)-Ketamine group | Experimental | Drug: Conventional therapy + S (+)-Ketamine In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection,but the recommended dosage is given, which is lower than the dosage specified in the instructions.
Recommended use and dosage of S (+)-Ketamine:
1. Bolus intravenous injection before skin incision, the dose is 0.1~0.5 mg/kg;
2. Bolus intravenous injection (dose 0.1~0.5 mg/kg) before skin incision +continuous intravenous infusion (dose of 0.1~0.25 mg/kg/h) during operation;
3. Continuous intravenous infusion after surgery with a dose of 0.02~0.1 mg/kg/h for 24~48 h. Receives: Drug: Conventional therapy + S (+)-Ketamine |
| Control group | Active comparator | Drug: Conventional therapy Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine. Receives: Drug: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the broken line of NRS score
The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain.
Measured: Hour 0-48 after surgery
Opioid consumption
Total opioid consumption(conversion to equivalent morphine)
Measured: Hour 0-48 after surgery
Secondary outcomes (11)
NRS pain scores
The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain.
Measured: Hour 0-48 after surgery
Time of first rescue analgesia
The time from the end of the operation to the first rescue analgesics after the operation. Rescue analgesia refers to the analgesia according to the patient's requirements in addition to routine postoperative analgesia.
Measured: Hour 0-48 after surgery
The incidence of rescue analgesia
The incidence of rescue analgesia within 48h after surgery
Measured: Hour 0-48 after surgery
Recovery time
The time from the end of the operation to recovery(can be awakened)
Measured: Day 0
The incidence of unexpected intraoperative events
Unexpected events during operation include intraoperative cough, laryngeal spasm, body movement, tachycardia,decreased oxygen saturation, respiratory depression, bradycardia, hypertension and hypotension.
Measured: Intraoperative
The Patient Efficacy Questionnaire (IPOQ ) scores
Patient Efficacy Questionnaire (IPOQ ) scale include 13 questions , each question's score is 0-10 or 0-100%, it involves postoperative pain, mood and quality of life. The higher the score, the more severe the pain symptoms.
Measured: Hour 48 after surgery
The incidence of adverse events after surgery
The incidence of adverse events from the end of the operation to 48h after surgery. Including nausea, vomiting, increased secretions, dizziness, oversedation, infection,anesthetic awareness, nightmares, restlessness, pruritus, disorientation, delirium, respiratory depression, diplopia, diarrhea, intestinal obstruction, urinary retention, gastroesophageal reflux, constipation, chills, hallucinations, etc.
Measured: Hour 0-48 after surgery
Pharmacoeconomic indicators
Calculating incremental cost-effectiveness ratio （ICER）based on cost-effectiveness analysis.
Measured: Hour 48 after surgery
Incidence of postoperative delirium
The Chinese version of the 3D-CAM scale is used for the diagnosis of delirium, and the assessment will be carried out at 24h, 48h and 72h after the operation. If the patient is discharged 72h after the patient is discharged, it may not be assessed.
Measured: Hour 0-48 after surgery
Simple Mental State Examination (MMSE) Scale score
The total score of Simple Mental State Examination Scale (MMSE) is 30,the higher the score, the better the cognitive function.
Measured: Hour 48 after surgery
Hospital Anxiety and Depression (HAD) Scale score
Hospital Anxiety and Depression Scale (HAD) includes anxiety measure(7questions,0-21pionts) and depression measure(7 questions,0-21pionts),the higher the score, the more severe thesymptoms.
Measured: Hour 48 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion30 Jun 2022 (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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group : Control group=2:1
- Masking
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Beijing Hospital, The Affiliated Hospital of Qingdao University, Renmin Hospital of Wuhan University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, Shengjing Hospital, Southern Medical University, China
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837170
- Sponsor's protocol ID
- SAFE-SK-A
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang H, Duan CY, Huang WQ, Zhao P, Zhou LZ, Liu YH, Liu CM, Chu HC, Wang Q, Diao YG, Hua Z, Meng QT, Li H, Zhang XY, Mi WD, Chen PY. Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial). BMJ Open. 2021 Dec 16;11(12):e054681. doi: 10.1136/bmjopen-2021-054681.
PubMed 34916327
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of S（+）-Ketamine for Postoperative Acute Pain in Adults in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT04837170
- Acronym / sponsor ID
- SAFE-SK-A
- Conditions
- Postoperative Pain, Adults, Anesthesia
- Keywords
- S-ketamine,Esketamine,S (+) - ketamine, Acute Pain, Depression, Anxiety, Delirium, Hyperalgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Beijing Hospital, The Affiliated Hospital of Qingdao University, Renmin Hospital of Wuhan University, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, Shengjing Hospital, Southern Medical University, China
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 8 Apr 2021 (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.
A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in adults in perioperative settings.
Detailed description
Patients often suffer acute pain after operation ，which may affect the recovery. Opioid such as morphine is the most commonly analgesic drugs, but opioid has many obviously adverse reactions ,for example respiratory depression,circulation inhibition,tolerance, addiction, nausea, vomiting, pruritus, etc. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese patients undergoing surgery.
Objective:Evaluate the efficacy and safety of S (+) - ketamine on acute perioperative pain for chinese adult patients,and look for the best dosage, mode of administration, timing, and compatibility ,as well explore the effect of S (+) - ketamine on postoperative delirium,anxiety ,depression and cognitive dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group : Control group=2:1
| Arm | Type | Receives |
|---|---|---|
| S (+)-Ketamine group | Experimental | Drug: Conventional therapy + S (+)-KetamineDrug: Conventional therapy + S (+)-Ketamine In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection,but the recommended dosage is given, which is lower than the dosage specified in the instructions. Recommended use and dosage of S (+)-Ketamine: 1. Bolus intravenous injection before skin incision, the dose is 0.1~0.5 mg/kg; 2. Bolus intravenous injection (dose 0.1~0.5 mg/kg) before skin incision +continuous intravenous infusion (dose of 0.1~0.25 mg/kg/h) during operation; 3. Continuous intravenous infusion after surgery with a dose of 0.02~0.1 mg/kg/h for 24~48 h. |
| Control group | Active comparator | Drug: Conventional therapyDrug: Conventional therapy Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Age ≥18 years old;
- 2. Scheduled for elective digestive tract surgery, gynecological surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or body surface surgery (thyroid surgery or breast surgery), head and neck surgery;
- 3. ASA score Ⅰ～Ⅲ;
- 4. The informed consent form was signed by the patients.
Key exclusion criteria (13 listed)
- 1. The expected length of hospital stay of the patient is less than 48h;
- 2. Patients expected to be admitted to the ICU after surgery;
- 3. Patients expected to return to the ward with tracheal catheter after surgery;
- 4. Be allergic to S (+) - ketamine;
- 5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
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 |
|---|---|---|
| Conventional therapy + S (+)-KetamineAlso: Conventional therapy + S-ketamine, Conventional therapy + EsketaminePatients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction,maintenance or postoperative analgesia. | Drug | S (+)-Ketamine group |
| Conventional therapyAlso: Routine treatmentReceiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine. | Drug | Control group |
Primary outcome
The area under the broken line of NRS score
Time frame: Hour 0-48 after surgery
The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain.
Opioid consumption
Time frame: Hour 0-48 after surgery
Total opioid consumption(conversion to equivalent morphine)
11 secondary outcomes
NRS pain scores
Time frame: Hour 0-48 after surgery
Time of first rescue analgesia
Time frame: Hour 0-48 after surgery
The incidence of rescue analgesia
Time frame: Hour 0-48 after surgery
Recovery time
Time frame: Day 0
The incidence of unexpected intraoperative events
Time frame: Intraoperative
The Patient Efficacy Questionnaire (IPOQ ) scores
Time frame: Hour 48 after surgery
The incidence of adverse events after surgery
Time frame: Hour 0-48 after surgery
Pharmacoeconomic indicators
Time frame: Hour 48 after surgery
Incidence of postoperative delirium
Time frame: Hour 0-48 after surgery
Simple Mental State Examination (MMSE) Scale score
Time frame: Hour 48 after surgery
Hospital Anxiety and Depression (HAD) Scale score
Time frame: Hour 48 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 34916327Wang H, Duan CY, Huang WQ, Zhao P, Zhou LZ, Liu YH, Liu CM, Chu HC, Wang Q, Diao YG, Hua Z, Meng QT, Li H, Zhang XY, Mi WD, Chen PY. Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial). BMJ Open. 2021 Dec 16;11(12):e054681. doi: 10.1136/bmjopen-2021-054681.
- 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.
Weidong Mi, MD study chair
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional therapy + S (+)-Ketamine and Conventional therapy in people with Postoperative Pain and Adults, run by Chinese PLA General Hospital.
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 4 inclusion and 13 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Weidong Mi, MD (8613381082966, wwdd1962@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the broken line of NRS score (time frame: Hour 0-48 after surgery). 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?
On the ClinicalTrials.gov record for NCT04837170, 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 8 Apr 2021.