Esketamine Administration on Recovery Quality After Radical Mastectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Esketamine and the Quality of Recovery
• Intervention / Treatment: Drug: Low-dose esketamine infusion; Drug: High-dose esketamine infusion; Drug: Saline infusion

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Anqing, Anhui, China, 246000
      • Department of Anqing Hospital Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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: 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.; Drug: 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.
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; 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: 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.; Drug: 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.
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; 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: 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.; Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Anqing Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 13, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Esketamine; The quality of recovery
• Additional Relevant MeSH Terms: Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: Zhumin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No