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Clinical trial

Effect of Intravenous S-ketamine on Opioid Consumption and Postoperative Pain in Patients Undergoing Breast Cancer Surgery：a Multicenter, Randomised, Control Trial

ID
Name
YX2021-070(F1)
Description
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.
Trial arms
Trial start
2021-10-07
Estimated PCD
2024-07-07
Trial end
2024-07-07
Status
Recruiting
Treatment
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.
Arms:
Low-dose ketamine group
Other names:
LKET
Placebo
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.
Arms:
Placebo group
Other names:
CON
S-ketamine (high dose)
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.
Arms:
High-dose ketamine group
Other names:
HKET
Size
352
Primary endpoint
consumption of sufentanil
during the surgery
Eligibility criteria
Inclusion Criteria: 1. Female patients with an American Society of Anesthesia (ASA) physical status I-II 2. Scheduled for elective breast cancer surgery Exclusion Criteria: 1. Patients unable to understand the study procedure or unable to give informed consent 2. with concurrent analgesic or sedative medication, 3. with history of chronic pain 4. with history of psychiatric disorders 5. with history of alcohol or drug abuse 6. with an allergy to the study medication 7. who are pregnant or breast feeding 8. with a BMI \>30 and \<18 kg/m\^2 9. with severe cardiac, pulmonary, hepatic or renal dysfunction 10. with intracranial hypertension
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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. Outcomes will be evaluated by anesthesiologists who are blinded to the treatment allocation. Patients, nurses, observers, and the statistician will be blinded to patient allocation throughout the study period.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 352, 'type': 'ESTIMATED'}}
Updated at
2023-08-25

1 organization

2 products

1 indication

Organization
The Second Hospital of Anhui Medical University
Product
S-ketamine
Indication
Breast Cancer Surgery
Product
Placebo