Effect of Intravenous S-ketamine on Opioid Consumption

NCT05060068 | Completed

• 1 other identifier: YX2021-070(F1)
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast cancer surgery; S-ketamine; opioid consumption

Outcome Measures

Primary Outcomes (1)

• consumption of sufentanil

  the consumption of sufentanil during the surgery.

  during the surgery

Secondary Outcomes (17)

• postoperative pain assessment

  at 0.5, 2, 4, 6, 12 and 24 hours respectively after surgery; Month 3 and Month 6 after surgery

• consumption of analgesics

  in the first 24 hour after surgery

• Richmond Agitation-Sedation Scale (RASS)

  30 minutes after surgery

• sleep quality scale

  sleep quality scale will be assessed in the morning (8:00 am）of first postoperative day

• consumption of propofol

  during the surgery

Study Arms (3)

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.

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.

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.

Drug: S-ketamine (high dose)

Interventions

S-ketamine (low dose) DRUG

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.

Also known as: LKET

Low-dose ketamine group

Placebo DRUG

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.

Also known as: CON

Placebo group

S-ketamine (high dose) DRUG

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.

Also known as: HKET

High-dose ketamine group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with an American Society of Anesthesia (ASA) physical status I-II
• Scheduled for elective breast cancer surgery

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

Second Affiliated Hospital of Anhui Medical University

Hefei, 230601, China

Location

Related Publications (2)

• 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.

  PMID: 32167978 BACKGROUND

• Hamp 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.

  PMID: 30442251 BACKGROUND

MeSH Terms

Interventions

Esketamine

Study Officials

• Ye Zhang, M.D., Ph. D.

  The Second Hospital of Anhui Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 28, 2021
• Study Start: October 7, 2021
• Primary Completion: July 7, 2024
• Study Completion: July 7, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD will become available when summary data are published.
• Access Criteria: Yun Wu and Ye Zhang will review requests and criteria to share IPD. Requests are to be sent by email to [email protected] or zhangye\ [email protected].

Locations

CN (1)