Esketamine Administration on Recovery Quality After Radical Mastectomy

Not Applicable

Completed

• Conditions: Esketamine and the Quality of Recovery
• Interventions: Drug: Low-dose esketamine infusion; Drug: High-dose esketamine infusion; Drug: Saline infusion

• Registration Number: NCT05289440
• Lead Sponsor: Anqing Municipal Hospital

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.

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-13
• Study Start: 2022-03-15
• Study First Posted: 2022-03-21
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose esketamine infusion on the quality of recovery after radical mastectomy	High-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.
Saline infusion on the quality of recovery after radical mastectomy	Low-dose esketamine 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.
Low-dose esketamine infusion on the quality of recovery after radical mastectomy	High-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.
Low-dose esketamine infusion on the quality of recovery after radical mastectomy	Low-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.
Saline infusion on the quality of recovery after radical mastectomy	High-dose esketamine 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.
Low-dose esketamine infusion on the quality of recovery after radical mastectomy	Saline 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.
High-dose esketamine infusion on the quality of recovery after radical mastectomy	Saline 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.
Saline infusion on the quality of recovery after radical mastectomy	Saline 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.
High-dose esketamine infusion on the quality of recovery after radical mastectomy	Low-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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Anqing Hospital Anesthesiology; 🇨🇳 Anqing, Anhui, China