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Completed

NCT Number: NCT05289440

Esketamine Administration on Recovery Quality After 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.

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Key information

Conditions

Esketamine and the Quality of Recovery

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anqing Hospital Anesthesiology

Anqing, Anhui, 246000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose esketamine infusion

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. Quality of recovery scores (QoR-15)

    Time frame: 1 day after operation

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

Secondary outcomes

  1. Pain visual analogue scale scores

    Time frame: The first 48 hours after operation

    Secondary Outcome Measure was pain visual analogue scale scores

Sponsors and collaborators

Lead sponsor

Anqing Municipal Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2022
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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