Esketamine Administration on Recovery Quality After Radical Mastectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Esketamine and the Quality of Recovery

Intervention / Treatment
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* Drug: Low-dose esketamine infusion
* Drug: High-dose esketamine infusion
* Drug: Saline infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose esketamine infusion on the quality of recovery after radical mastectomy<br>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<br>* 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.<br>Drug: High-dose esketamine infusion<br>* 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.<br>Drug: Saline infusion<br>* 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.<br>|
| Experimental: High-dose esketamine infusion on the quality of recovery after radical mastectomy<br>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<br>* 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.<br>Drug: High-dose esketamine infusion<br>* 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.<br>Drug: Saline infusion<br>* 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.<br>|
| Experimental: Saline infusion on the quality of recovery after radical mastectomy<br>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<br>* 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.<br>Drug: High-dose esketamine infusion<br>* 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.<br>Drug: Saline infusion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esketamine, The quality of recovery