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CompletedNCT05289440Updated Nov 9, 2022

Esketamine Administration on Recovery Quality After Radical Mastectomy

An interventional study of Low-dose esketamine infusion and High-dose esketamine infusion in Esketamine and the Quality of Recovery, sponsored by Anqing Municipal Hospital. Completed at 1 site in China. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by Anqing Municipal Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Female
01

Study summary

Some studies have reported that intravenous esketamine reduce postoperative pain intensity. The investigators investigated whether esketamine could improve the the quality of recovery after modified radical mastectomy.

Read the detailed description

A total of 111 patients were randomly allocated into 3 groups. Patients in group LE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin. Patients in group HE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin. Patients in group CON received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

02

Conditions studied

  • Esketamine and the Quality of Recovery

Keywords

  • Esketamine
  • The quality of recovery
03

In context

Lead sponsor

Anqing Municipal Hospital is the lead sponsor of 10 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status
  • Scheduled for elective modified radical mastectomy

Exclusion criteria

Exclusion Criteria:

  • Severe respiratory disease
  • Renal or hepatic insufficiency
  • History of preoperative psychiatric
  • Preoperative hypertension
  • Preoperative history of chronic pain
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Low-dose esketamine infusion on the quality of recovery after radical mastectomy

    Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.

    Drug: Low-dose esketamine infusion · Drug: High-dose esketamine infusion · Drug: Saline infusion

  • Experimental
    High-dose esketamine infusion on the quality of recovery after radical mastectomy

    Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.

    Drug: Low-dose esketamine infusion · Drug: High-dose esketamine infusion · Drug: Saline infusion

  • Experimental
    Saline infusion on the quality of recovery after radical mastectomy

    Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

    Drug: Low-dose esketamine infusion · Drug: High-dose esketamine infusion · Drug: Saline infusion

Interventions

  • DrugLow-dose esketamine infusion

    Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.

  • DrugHigh-dose esketamine infusion

    Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.

  • DrugSaline infusion

    Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

06

What researchers measure

Primary outcomes

  1. Quality of recovery scores (QoR-15)

    Our primary outcome was quality of recovery scores (QoR-15) 1 day after operation

    Time frame: 1 day after operation

Secondary outcomes

  1. Pain visual analogue scale scores

    Secondary Outcome Measure was pain visual analogue scale scores

    Time frame: The first 48 hours after operation

07

Study locations

1 site
  • Department of Anqing Hospital Anesthesiology
    Anqing, Anhui 246000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05289440
Lead sponsor
Anqing Municipal Hospital
Responsible party
Sponsor
First posted
Mar 21, 2022
Start date
Mar 15, 2022
Primary completion
Sep 15, 2022
Completion
Sep 20, 2022
Last update
Nov 9, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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