Esketamine and the Quality of RecoveryNCT05289440
Esketamine Administration on Recovery Quality After Radical Mastectomy
A study testing Low-dose esketamine infusion, High-dose esketamine infusion and Saline infusion in people with Esketamine and the Quality of Recovery, run by Anqing Municipal Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Esketamine and the Quality of Recovery
- What is being tested?
- Low-dose esketamine infusion, High-dose esketamine infusion and Saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2022to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status
- Scheduled for elective modified radical mastectomy
Who cannot join
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative psychiatric
- Preoperative hypertension
- Preoperative history of chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Esketamine and the Quality of Recovery
- Being tested
- Low-dose esketamine infusion, High-dose esketamine infusion, Saline infusion
- Keywords
- Esketamine, The quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose esketamine infusionDrug
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 infusionDrug
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 infusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose esketamine infusion on the quality of recovery after radical mastectomy | Experimental | 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. Receives: Drug: Low-dose esketamine infusion; Drug: High-dose esketamine infusion; Drug: Saline infusion |
| High-dose esketamine infusion on the quality of recovery after radical mastectomy | Experimental | 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. Receives: Drug: Low-dose esketamine infusion; Drug: High-dose esketamine infusion; Drug: Saline infusion |
| Saline infusion on the quality of recovery after radical mastectomy | Experimental | 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. Receives: Drug: Low-dose esketamine infusion; Drug: High-dose esketamine infusion; Drug: Saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery scores (QoR-15)
Our primary outcome was quality of recovery scores (QoR-15) 1 day after operation
Measured: 1 day after operation
Secondary outcomes (1)
Pain visual analogue scale scores
Secondary Outcome Measure was pain visual analogue scale scores
Measured: The first 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start15 Mar 2022
- Primary completion15 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esketamine and the Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anqing Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289440
- Sponsor's protocol ID
- Zhumin
- Status last verified
- Nov 2022
- First submitted
- 10 Mar 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esketamine on the Quality of Recovery After Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT05289440
- Acronym / sponsor ID
- Zhumin
- Conditions
- Esketamine and the Quality of Recovery
- Keywords
- Esketamine, The quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose esketamine infusion on the quality of recovery after radical mastectomy | Experimental | Drug: Low-dose esketamine infusion, Drug: High-dose esketamine infusion, Drug: Saline infusionPatients 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 | Experimental | Drug: Low-dose esketamine infusion, Drug: High-dose esketamine infusion, Drug: Saline infusionPatients 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 | Experimental | Drug: Low-dose esketamine infusion, Drug: High-dose esketamine infusion, Drug: Saline infusionPatients 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 may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status
- Scheduled for elective modified radical mastectomy
Key exclusion criteria (5 listed)
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative psychiatric
- Preoperative hypertension
- Preoperative history of chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose esketamine infusionPatients 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 on the quality of recovery after radical mastectomy, Low-dose esketamine infusion on the quality of recovery after radical mastectomy, Saline infusion on the quality of recovery after radical mastectomy |
| High-dose esketamine infusionPatients 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 | High-dose esketamine infusion on the quality of recovery after radical mastectomy, Low-dose esketamine infusion on the quality of recovery after radical mastectomy, Saline infusion on the quality of recovery after radical mastectomy |
| Saline infusionPatients 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 | High-dose esketamine infusion on the quality of recovery after radical mastectomy, Low-dose esketamine infusion on the quality of recovery after radical mastectomy, Saline infusion on the quality of recovery after radical mastectomy |
Primary outcome
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
1 secondary outcome
Pain visual analogue scale scores
Time frame: The first 48 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
Related trials for Esketamine and the Quality of Recovery
RecruitingPhase 4
Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery
General Anesthesia, Surgery
RecruitingPhase 4
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Sleep Wake Disorders, Esketamine and the Quality of Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose esketamine infusion, High-dose esketamine infusion and Saline infusion in people with Esketamine and the Quality of Recovery, run by Anqing Municipal Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery scores (QoR-15) (time frame: 1 day after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.