Dexmedetomidine, Esketamine, Postoperative Pain and Recovery QualityNCT05283408
The Clinical Study of Dexmedetomidine and Esketamine Combined Infusion Undergoing Modified Radical Mastectomy
A study testing Dexmedetomidine infusion, Co-administration dexmedetomidine and low-dose esketamine infusion and Co-administration dexmedetomidine and high-dose esketamine infusion in people with Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality, run by Anqing Municipal Hospital at 1 site in China.
Trial summary
BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine alleviated postoperative pain and improve the quality of recovery after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better alleviated postoperative pain and improve the the… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality
- What is being tested?
- Dexmedetomidine infusion, Co-administration dexmedetomidine and low-dose esketamine infusion and Co-administration dexmedetomidine and high-dose esketamine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2022to 30 Mar 2023
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ
- Scheduled for elective modified radical mastectomy
Who cannot join
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative psychiatric
- Preoperative bradycardia
- Preoperative atrioventricular block
- Preoperative hypertension
- BMI>30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmedetomidine and Esketamine Combined Infusion on Postoperative Pain and Recovey Quality Undergoing Modified Radical Mastectomy
BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine alleviated postoperative pain and improve the quality of recovery after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better alleviated postoperative pain and improve the the quality of recovery after modified radical mastectomy.
METHODS: One hundred and thirty-five women with elective modified radical mastectomy were randomly divided into 3 groups: Patients in group D received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation. Patients in group DE1 received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. Patients in group DE2 received received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery and 3 day after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea, vomiting and bradycardia, hallucination, nightmare, as well as postoperative rescue analgesics and anti-emetics, recovery time, and extubation time.
- Being tested
- Dexmedetomidine infusion, Co-administration dexmedetomidine and low-dose esketamine infusion, Co-administration dexmedetomidine and high-dose esketamine infusion
- Keywords
- Dexmedetomidine, esketamine, pain, recovery quality
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusionDrug
Patients received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation
Co-administration dexmedetomidine and low-dose esketamine infusionDrug
Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively.
Co-administration dexmedetomidine and high-dose esketamine infusionDrug
Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine infusion on recovey quality with radical mastectomy | Experimental | Drug: Dexmedetomidine infusion Patients received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation Receives: Drug: Dexmedetomidine infusion; Drug: Co-administration dexmedetomidine and low-dose esketamine infusion; Drug: Co-administration dexmedetomidine and high-dose esketamine infusion |
| Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy | Experimental | Drug: Dexmedetomidine and low-dose eskeamine combined infusion Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. Receives: Drug: Dexmedetomidine infusion; Drug: Co-administration dexmedetomidine and low-dose esketamine infusion; Drug: Co-administration dexmedetomidine and high-dose esketamine infusion |
| Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy | Experimental | Drug: Dexmedetomidine and high-dose eskeamine combined infusion Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. Receives: Drug: Dexmedetomidine infusion; Drug: Co-administration dexmedetomidine and low-dose esketamine infusion; Drug: Co-administration dexmedetomidine and high-dose esketamine 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 (3)
Intraoperative remifentanil total dose
Secondary Outcome Measure was remifentanil total dose during the perioperative period
Measured: Intraoperative
Pain visual analogue scale scores
Secondary Outcome Measure was pain visual analogue scale scores
Measured: The first 48 hours after operation
incidence of PONV
Secondary Outcome Measure was incidence of PONV
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 posted17 Mar 2022
- Study start10 Apr 2022
- Primary completion20 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexmedetomidine, Esketamine, Postoperative Pain and Recovery QualityStudies 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
- 135 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
- NCT05283408
- Sponsor's protocol ID
- Xuwen521
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine and Esketamine Combined Infusion on Postoperative Pain and Recovey Quality Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT05283408
- Acronym / sponsor ID
- Xuwen521
- Keywords
- Dexmedetomidine, esketamine, pain, recovery quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 17 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.
BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine alleviated postoperative pain and improve the quality of recovery after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better alleviated postoperative pain and improve the the quality of recovery after modified radical mastectomy.
METHODS: One hundred and thirty-five women with elective modified radical mastectomy were randomly divided into 3 groups: Patients in group D received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation. Patients in group DE1 received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. Patients in group DE2 received received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery and 3 day after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea, vomiting and bradycardia, hallucination, nightmare, as well as postoperative rescue analgesics and anti-emetics, recovery time, and extubation time.
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 |
|---|---|---|
| Dexmedetomidine infusion on recovey quality with radical mastectomy | Experimental | Drug: Dexmedetomidine infusion, Drug: Co-administration dexmedetomidine and low-dose esketamine infusion, Drug: Co-administration dexmedetomidine and high-dose esketamine infusionDrug: Dexmedetomidine infusion Patients received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation |
| Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy | Experimental | Drug: Dexmedetomidine infusion, Drug: Co-administration dexmedetomidine and low-dose esketamine infusion, Drug: Co-administration dexmedetomidine and high-dose esketamine infusionDrug: Dexmedetomidine and low-dose eskeamine combined infusion Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. |
| Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy | Experimental | Drug: Dexmedetomidine infusion, Drug: Co-administration dexmedetomidine and low-dose esketamine infusion, Drug: Co-administration dexmedetomidine and high-dose esketamine infusionDrug: Dexmedetomidine and high-dose eskeamine combined infusion Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ
- Scheduled for elective modified radical mastectomy
Key exclusion criteria (7 listed)
- Severe respiratory disease
- Renal or hepatic insufficiency
- History of preoperative psychiatric
- Preoperative bradycardia
- Preoperative atrioventricular block
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 |
|---|---|---|
| Dexmedetomidine infusionPatients received dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until 20 min before the end of operation | Drug | Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy, Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy, Dexmedetomidine infusion on recovey quality with radical mastectomy |
| Co-administration dexmedetomidine and low-dose esketamine infusionPatients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 2 µg/kg/min until 20 min before the end of operation, respectively. | Drug | Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy, Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy, Dexmedetomidine infusion on recovey quality with radical mastectomy |
| Co-administration dexmedetomidine and high-dose esketamine infusionPatients received a bolus infusion of dexmedetomidine (0.5 µg/kg) and esketamine (0.5 mg/kg)over 10 min before the induction of anesthesia, and then dexmedetomidine were infused at a rate of 0.4 µg/kg/h and 4 µg/kg/min until 20 min before the end of operation, respectively. | Drug | Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy, Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy, Dexmedetomidine infusion on recovey quality with 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
3 secondary outcomes
Intraoperative remifentanil total dose
Time frame: Intraoperative
Pain visual analogue scale scores
Time frame: The first 48 hours after operation
incidence of PONV
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 13 Apr 2023.
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 Dexmedetomidine infusion, Co-administration dexmedetomidine and low-dose esketamine infusion and Co-administration dexmedetomidine and high-dose esketamine infusion in people with Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality, 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 7 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 13 Apr 2023. 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 13 Apr 2023.