Safety and efficacy of low-opioid anesthesia in breast cancer surgery—a multicenter, prospective, randomized, controlled trial.

Effects of esketamine on the dosage of sufentanil and postoperative pain in patients with radical mastectomy for breast cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200061136

Enrollment

Unknown

Registered

2022-06-15

Start date

2022-06-01

Completion date

Unknown

Last updated

2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

low-dose esketamine group:Esketamine 0.5 mg/kg intravenously loaded prior to skin incision, followed by continuous infusion of 2 µg/kg/min until the start of the seam skin

high-dose esketamine group:Esketamine 0.5 mg/kg intravenously loaded prior to skin incision, followed by continuous infusion of 4 µg/kg/min until the start of the seam skin

saline control group:Before skin incision, the same volume of normal saline was given intravenously, followed by continuous infusion of normal saline until the beginning of skin suture

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective radical mastectomy for breast cancer; 2. No age limit, ASA I-II; 3. Those who voluntarily join and sign informed consent after fully explaining the content of the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients with severe pulmonary hypertension, arrhythmia or cardiac insufficiency; 2. Patients with liver and kidney dysfunction; 3. Patients with increased intracranial pressure or intraocular pressure; 4. Patients who have recently taken analgesic and sedative drugs; 5. Patients with chronic pain in the past; 6. Mental disorders or alcohol and drug abusers; 7. Patients who are allergic to the drugs used in the study; 8. Patients who are pregnant or breastfeeding; 9. Patients who refuse to use postoperative analgesia; 10. Patients who have participated in other treatments in the last 6 months (when consent is obtained); 11. Patients who are judged to lack the ability to consent; 13. Other patients who are judged as inappropriate by the clinically responsible doctor or the clinically in charge.

Design outcomes

Primary

Measure	Time frame
Intraoperative sufentanil dosage;Dosage of postoperative analgesics;	—

Secondary

Measure	Time frame
Intraoperative dosage of propofol, remifentanil, and non-steroidal anti-inflammatory drugs;	—

Countries

China

Contacts

Public ContactXin Wang

anaesthes@126.com+86 13956089142

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026