Esketamine Administration on Recovery Quality After Radical Mastectomy

The Effect of Esketamine on the Quality of Recovery After Modified Radical Mastectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05289440

Enrollment

105

Registered

2022-03-21

Start date

2022-03-15

Completion date

2022-09-20

Last updated

2022-11-09

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

Conditions

Esketamine and the Quality of Recovery

Keywords

Esketamine, The quality of recovery

Brief 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.

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of recovery scores (QoR-15)	1 day after operation	Our primary outcome was quality of recovery scores (QoR-15) 1 day after operation

Secondary

Measure	Time frame	Description
Pain visual analogue scale scores	The first 48 hours after operation	Secondary Outcome Measure was pain visual analogue scale scores

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026