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Effect of Intravenous S-ketamine on Opioid Consumption

NCT05060068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2024-08-06

No results posted yet for this study

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. The primary outcome is the consumption of sufentanil during the surgery.

Conditions

  • Breast Cancer Surgery

Interventions

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • The Second Hospital of Anhui Medical University

    lead OTHER

Principal Investigators

  • Ye Zhang, M.D., Ph. D. · The Second Hospital of Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-07
Primary Completion
2024-07-07
Completion
2024-07-07

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05060068 on ClinicalTrials.gov