Esketamine Administration on Recovery Quality After Radical Mastectomy
The Effect of Esketamine on the Quality of Recovery After Modified Radical Mastectomy
1 other identifier
interventional
105
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2022
CompletedNovember 9, 2022
November 1, 2022
6 months
March 10, 2022
November 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pain visual analogue scale scores
The first 48 hours after operation
Study Arms (3)
Low-dose esketamine infusion on the quality of recovery after radical mastectomy
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
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.
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.
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.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA) physical status
- Scheduled for elective modified radical mastectomy
You may not qualify if:
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative psychiatric
- Preoperative hypertension
- Preoperative history of chronic pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anqing Hospital Anesthesiology
Anqing, Anhui, 246000, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 21, 2022
Study Start
March 15, 2022
Primary Completion
September 15, 2022
Study Completion
September 20, 2022
Last Updated
November 9, 2022
Record last verified: 2022-11