Breast Cancer SurgeryNCT05060068
Effect of Intravenous S-ketamine on Opioid Consumption
A study testing S-ketamine (low dose) and S-ketamine (high dose) in people with Breast Cancer Surgery, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
Female patients with an American Society of Anesthesia (ASA) physical status I-II, scheduled for elective breast cancer surgery will be included in the study. Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Surgery
- What is being tested?
- S-ketamine (low dose) and S-ketamine (high dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 345 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2021to 7 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female patients with an American Society of Anesthesia (ASA) physical status I-II
- Scheduled for elective breast cancer surgery
Who cannot join
- Patients unable to understand the study procedure or unable to give informed consent
- with concurrent analgesic or sedative medication,
- with history of chronic pain
- with history of psychiatric disorders
- with history of alcohol or drug abuse
- with an allergy to the study medication
Show all 10Show fewer
- who are pregnant or breast feeding
- with a BMI >30 and <18 kg/m^2
- with severe cardiac, pulmonary, hepatic or renal dysfunction
- with intracranial hypertension
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Anhui Medical University
Hefei, 230601
About this study
Official title: Effect of Intravenous S-ketamine on Opioid Consumption and Postoperative Pain in Patients Undergoing Breast Cancer Surgery：a Multicenter, Randomised, Control Trial
Female patients with an American Society of Anesthesia (ASA) physical status I-II, scheduled for elective breast cancer surgery will be included in the study. Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The primary outcome is the consumption of sufentanil during the surgery.
Read the detailed description
All patients will be scheduled to a propofol-remifentanil general anesthesia and receive non-steroid anti-inflammatory drug before incision. Bolus sufentanil will be administered according to the blood pressure, heart rate and bispectral index perioperatively. Patients unable to understand the study procedure or unable to give informed consent, with concurrent analgesic or sedative medication, with history of chronic pain, psychiatric disorders, or alcohol or drug abuse, with an allergy to the study medication, who are pregnant or breast feeding, with a BMI >30 and <18 kg/m2, with severe cardiac, pulmonary, hepatic or renal dysfunction, with intracranial hypertension will be excluded.
Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The study medication will be administered in a bolus injected over 30 s after induction, followed by continuous infusion, which started after the initial bolus. The placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline. The low-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by 2μg/kg/min S-ketamine in saline, whereas the high-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4μg/kg/min S-ketamine in saline. The syringes and infusions will be identical for all of the groups and will run at the same rate in all subjects to enable blinding of the investigators. Study medication will be terminated 30 min prior to the end of the surgery. After surgery and in the postanesthesia care unit, patients will be asked about their pain level on a numeric rating scale (NRS), and about the presence of intraoperative awareness, nausea, vomiting, and hallucinations. Rescue analgesia of sufentanil will be provided when NRS ≥ 4 or patients require. Pain level will also be assessed at 0.5, 2, 4, 6, 12 and 24 hour postoperatively as well as 3 and 6 month after the surgery. Depression scale will be evaluated before the surgery and in the 7th postoperative day.
- Conditions
- Breast Cancer Surgery
- Being tested
- S-ketamine (low dose), Placebo, S-ketamine (high dose)
- Keywords
- breast cancer surgery, S-ketamine, opioid consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamine (low dose)Drug
Also called LKET
Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
PlaceboDrug
Also called CON
Patients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery.
S-ketamine (high dose)Drug
Also called HKET
Patients in the high-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Patients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery. Receives: Drug: Placebo |
| Low-dose ketamine group | Experimental | Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery. Receives: Drug: S-ketamine (low dose) |
| High-dose ketamine group | Experimental | Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery. Receives: Drug: S-ketamine (high dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of sufentanil
the consumption of sufentanil during the surgery.
Measured: during the surgery
Secondary outcomes (17)
postoperative pain assessment
Patients will be asked about their pain level at rest and moving on a numeric rating scale evaluated on a 11-point (0 = no pain, 10 = worst pain imaginable).
Measured: at 0.5, 2, 4, 6, 12 and 24 hours respectively after surgery; Month 3 and Month 6 after surgery
consumption of analgesics
cumulative analgesic consumption after surgery
Measured: in the first 24 hour after surgery
Richmond Agitation-Sedation Scale (RASS)
Richmond Agitation-Sedation Scale is a 10-point scale. The values and definitions for each level of agitation and sedation are displayed as follows: +4, Combative, overtly combative or violent; immediate danger to staff; +3, Very agitation, pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff; +2, Agitated, frequent nonpurposeful movement or patient-ventilator dyssynchrony; +1, Restless, anxious or apprehensive but movements not aggressive or vigorous; 0, Alert and calm; -1, Drowsy, not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice; -2, Light sedation, briefly (less than 10 seconds) awakens with eye contact to voice; -3, Moderate sedation, any movement (but no eye contact) to voice; -4, Deep sedation, no response to voice, but any movement to physical stimulation; -5, Unarousable, no response to voice or physical stimulation
Measured: 30 minutes after surgery
sleep quality scale
Quality of sleep in the night of surgery day using a 4-point scale (1 = "slept well," 2 = "disturbed sleep," 3 = "nightmares," and 4 = "sleepless") will be recorded.
Measured: sleep quality scale will be assessed in the morning (8:00 am）of first postoperative day
consumption of propofol
the consumption of propofol during the surgery.
Measured: during the surgery
consumption of remifentanil
the consumption of remifentanil during the surgery.
Measured: during the surgery
length of anesthesia
from beginning to the end of anesthesia
Measured: at the end of anesthesia
length of surgery
from beginning to the end of surgery
Measured: at the end of surgery
recovery time
awakening time from surgery
Measured: at the time when patients waking up
consumption of vasoactive agents
the consumption of any vasoactive agent (such as phenylephrine, urapidil, ephedrine)
Measured: during the surgery
blood pressure
noninvasive blood pressure
Measured: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery
heart rate
Heart rate of the patients
Measured: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery
bispectral index
Bispectral index during the surgery
Measured: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery
adverse effects
The presence of intraoperative awareness, nausea, vomiting, and hallucinations after surgery
Measured: through 24 hours after the surgery
Edinburgh postnatal depression scale
Depression scale generated from Edinburgh postnatal depression scale will be assessed. The minimum value is 0, and the maximum value is 30. The higher score means the higher possibility of depression.
Measured: before surgery, at the 7th day and 3 months after surgery
ambulation time
interval time of patients' transit from bed rest to ambulation after surgery
Measured: 7 days after surgery
hospitalization postoperatively
days of hospital staying after surgery
Measured: two weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start7 Oct 2021
- Primary completion7 Jul 2024
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- 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
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Wu, The Second Hospital of Anhui Medical University
- Investigators
- Ye Zhang, M.D., Ph. D., Study chair, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060068
- Sponsor's protocol ID
- YX2021-070(F1)
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication are to be shared with other researchers.
Publications
Brinck ECV, Maisniemi K, Kankare J, Tielinen L, Tarkkila P, Kontinen VK. Analgesic Effect of Intraoperative Intravenous S-Ketamine in Opioid-Naive Patients After Major Lumbar Fusion Surgery Is Temporary and Not Dose-Dependent: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Anesth Analg. 2021 Jan;132(1):69-79. doi: 10.1213/ANE.0000000000004729.
PubMed 32167978Hamp T, Baron-Stefaniak J, Krammel M, Reiter B, Langauer A, Stimpfl T, Plochl W. Effect of intravenous S-ketamine on the MAC of sevoflurane: a randomised, placebo-controlled, double-blinded clinical trial. Br J Anaesth. 2018 Dec;121(6):1242-1248. doi: 10.1016/j.bja.2018.08.023. Epub 2018 Oct 15.
PubMed 30442251
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous S-ketamine on Opioid Consumption and Postoperative Pain in Patients Undergoing Breast Cancer Surgery：a Multicenter, Randomised, Control Trial
- ClinicalTrials.gov ID
- NCT05060068
- Acronym / sponsor ID
- YX2021-070(F1)
- Conditions
- Breast Cancer Surgery
- Keywords
- breast cancer surgery, S-ketamine, opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 28 Sep 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.
Female patients with an American Society of Anesthesia (ASA) physical status I-II, scheduled for elective breast cancer surgery will be included in the study. Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The primary outcome is the consumption of sufentanil during the surgery.
Detailed description
All patients will be scheduled to a propofol-remifentanil general anesthesia and receive non-steroid anti-inflammatory drug before incision. Bolus sufentanil will be administered according to the blood pressure, heart rate and bispectral index perioperatively. Patients unable to understand the study procedure or unable to give informed consent, with concurrent analgesic or sedative medication, with history of chronic pain, psychiatric disorders, or alcohol or drug abuse, with an allergy to the study medication, who are pregnant or breast feeding, with a BMI >30 and <18 kg/m2, with severe cardiac, pulmonary, hepatic or renal dysfunction, with intracranial hypertension will be excluded.
Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The study medication will be administered in a bolus injected over 30 s after induction, followed by continuous infusion, which started after the initial bolus. The placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline. The low-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by 2μg/kg/min S-ketamine in saline, whereas the high-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4μg/kg/min S-ketamine in saline. The syringes and infusions will be identical for all of the groups and will run at the same rate in all subjects to enable blinding of the investigators. Study medication will be terminated 30 min prior to the end of the surgery. After surgery and in the postanesthesia care unit, patients will be asked about their pain level on a numeric rating scale (NRS), and about the presence of intraoperative awareness, nausea, vomiting, and hallucinations. Rescue analgesia of sufentanil will be provided when NRS ≥ 4 or patients require. Pain level will also be assessed at 0.5, 2, 4, 6, 12 and 24 hour postoperatively as well as 3 and 6 month after the surgery. Depression scale will be evaluated before the surgery and in the 7th postoperative day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboPatients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery. |
| Low-dose ketamine group | Experimental | Drug: S-ketamine (low dose)Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery. |
| High-dose ketamine group | Experimental | Drug: S-ketamine (high dose)Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients with an American Society of Anesthesia (ASA) physical status I-II
- Scheduled for elective breast cancer surgery
Key exclusion criteria (10 listed)
- Patients unable to understand the study procedure or unable to give informed consent
- with concurrent analgesic or sedative medication,
- with history of chronic pain
- with history of psychiatric disorders
- with history of alcohol or drug abuse
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 |
|---|---|---|
| S-ketamine (low dose)Also: LKETPatients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery. | Drug | Low-dose ketamine group |
| PlaceboAlso: CONPatients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery. | Drug | Placebo group |
| S-ketamine (high dose)Also: HKETPatients in the high-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery. | Drug | High-dose ketamine group |
Primary outcome
consumption of sufentanil
Time frame: during the surgery
the consumption of sufentanil during the surgery.
17 secondary outcomes
postoperative pain assessment
Time frame: at 0.5, 2, 4, 6, 12 and 24 hours respectively after surgery; Month 3 and Month 6 after surgery
consumption of analgesics
Time frame: in the first 24 hour after surgery
Richmond Agitation-Sedation Scale (RASS)
Time frame: 30 minutes after surgery
sleep quality scale
Time frame: sleep quality scale will be assessed in the morning (8:00 am）of first postoperative day
consumption of propofol
Time frame: during the surgery
consumption of remifentanil
Time frame: during the surgery
length of anesthesia
Time frame: at the end of anesthesia
length of surgery
Time frame: at the end of surgery
recovery time
Time frame: at the time when patients waking up
consumption of vasoactive agents
Time frame: during the surgery
blood pressure
Time frame: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery
heart rate
Time frame: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery
bispectral index
Time frame: before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery
adverse effects
Time frame: through 24 hours after the surgery
Edinburgh postnatal depression scale
Time frame: before surgery, at the 7th day and 3 months after surgery
ambulation time
Time frame: 7 days after surgery
hospitalization postoperatively
Time frame: two weeks after surgery
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 6 Aug 2024.
- Background: PubMed 32167978Brinck ECV, Maisniemi K, Kankare J, Tielinen L, Tarkkila P, Kontinen VK. Analgesic Effect of Intraoperative Intravenous S-Ketamine in Opioid-Naive Patients After Major Lumbar Fusion Surgery Is Temporary and Not Dose-Dependent: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Anesth Analg. 2021 Jan;132(1):69-79. doi: 10.1213/ANE.0000000000004729.
- Background: PubMed 30442251Hamp T, Baron-Stefaniak J, Krammel M, Reiter B, Langauer A, Stimpfl T, Plochl W. Effect of intravenous S-ketamine on the MAC of sevoflurane: a randomised, placebo-controlled, double-blinded clinical trial. Br J Anaesth. 2018 Dec;121(6):1242-1248. doi: 10.1016/j.bja.2018.08.023. Epub 2018 Oct 15.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication are to be shared with other researchers.
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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.
Ye Zhang, M.D., Ph. D. study chair
The Second Hospital of Anhui 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 S-ketamine (low dose) and S-ketamine (high dose) in people with Breast Cancer Surgery, run by The Second Hospital of Anhui Medical University 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 2 inclusion and 10 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 6 Aug 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. Some participants in this study may receive a placebo. 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?
consumption of sufentanil (time frame: during the surgery). 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 NCT05060068, which also lists 2 linked publications.
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 6 Aug 2024.