Dexmedetomidine Plus Esketamine Affect Postoperative Sleep QualityNCT06414941
The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy
A study testing Dexmedetomidine administration, Dexmedetomidine plus low-dose esketamine administration and Dexmedetomidine plus high-dose esketamine administration in people with Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality, run by Anqing Municipal Hospital at 1 site in China.
Trial summary
BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine improve the quality of sleep after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better improve the the quality of sleep after modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality
- What is being tested?
- Dexmedetomidine administration, Dexmedetomidine plus low-dose esketamine administration and Dexmedetomidine plus high-dose esketamine administration
- 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 May 2024to 20 Oct 2024
- 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 25 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.
China1 site, 1 recruiting
- Recruiting
Department of Anqing Hospital Anesthesiology
Anqing, Anhui, 246003
About this study
Official title: Dexmedetomidine Combined With Esketamine Effects the Quality of Sleep
BACKGROUND: Some studies have revealed that intravenous dexmedetomidine and esketamine improve the quality of sleep after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better improve the the quality of sleep after modified radical mastectomy.
METHODS: One hundred and 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 sleep (PSQI) at the day after surgery and 1 day after surgery. The secondary outcomes included MAP, HR, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea and vomiting, hallucination, as well as agitation, drowness, postoperative rescue analgesics and anti-emetics, recovery time, and extubation time.
- Being tested
- Dexmedetomidine administration, Dexmedetomidine plus low-dose esketamine administration, Dexmedetomidine plus high-dose esketamine administration
- Keywords
- Esketamine, Sleep quality, Dexmedetomidine
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine administrationDrug
atients 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
Dexmedetomidine plus low-dose esketamine administrationDrug
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.
Dexmedetomidine plus high-dose esketamine administrationDrug
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 on sleep quality with radical mastectomy | Experimental | 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 administration; Drug: Dexmedetomidine plus low-dose esketamine administration; Drug: Dexmedetomidine plus high-dose esketamine administration |
| Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy | Experimental | 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 administration; Drug: Dexmedetomidine plus low-dose esketamine administration; Drug: Dexmedetomidine plus high-dose esketamine administration |
| Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy | Experimental | 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 administration; Drug: Dexmedetomidine plus low-dose esketamine administration; Drug: Dexmedetomidine plus high-dose esketamine administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index (PSQI)
Our primary outcome was Pittsburgh sleep quality index (PSQI) at the day after surgery
Measured: the day after surgery
Secondary outcomes (2)
Pittsburgh sleep quality index (PSQI)
Our primary outcome was Pittsburgh sleep quality index (PSQI) on 1 day after surgery
Measured: 1 day after surgery
pain visual analogue scale scores
Our primary outcome 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 posted16 May 2024
- Study start15 May 2024 (estimated)
- Primary completion10 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexmedetomidine Plus Esketamine Affect Postoperative Sleep 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anqing Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414941
- Sponsor's protocol ID
- errtg555
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Combined With Esketamine Effects the Quality of Sleep
- ClinicalTrials.gov ID
- NCT06414941
- Acronym / sponsor ID
- errtg555
- Keywords
- Esketamine, Sleep quality, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Anqing Municipal HospitalUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 16 May 2024 (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 improve the quality of sleep after surgery. The investigators investigated whether co-administration dexmedetomidine and esketamine could better improve the the quality of sleep after modified radical mastectomy.
METHODS: One hundred and 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 sleep (PSQI) at the day after surgery and 1 day after surgery. The secondary outcomes included MAP, HR, postoperative VAS pain scores, side effects such as the incidence of postoperative nausea and vomiting, hallucination, as well as agitation, drowness, postoperative rescue analgesics and anti-emetics, recovery time, and extubation time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine on sleep quality with radical mastectomy | Experimental | Drug: Dexmedetomidine administration, Drug: Dexmedetomidine plus low-dose esketamine administration, Drug: Dexmedetomidine plus high-dose esketamine administrationDexmedetomidine 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 |
| Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy | Experimental | Drug: Dexmedetomidine administration, Drug: Dexmedetomidine plus low-dose esketamine administration, Drug: Dexmedetomidine plus high-dose esketamine administrationDexmedetomidine 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. |
| Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy | Experimental | Drug: Dexmedetomidine administration, Drug: Dexmedetomidine plus low-dose esketamine administration, Drug: Dexmedetomidine plus high-dose esketamine administrationDexmedetomidine 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
- 25 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 administrationatients 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 | Dexmedetomidine on sleep quality with radical mastectomy, Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy, Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy |
| Dexmedetomidine plus low-dose esketamine administrationPatients 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 | Dexmedetomidine on sleep quality with radical mastectomy, Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy, Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy |
| Dexmedetomidine plus high-dose esketamine administrationPatients 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 | Dexmedetomidine on sleep quality with radical mastectomy, Dexmedetomidine plus high- dose esketamine on sleep quality with radical mastectomy, Dexmedetomidine plus low-dose esketamine on sleep quality with radical mastectomy |
Primary outcome
Pittsburgh sleep quality index (PSQI)
Time frame: the day after surgery
Our primary outcome was Pittsburgh sleep quality index (PSQI) at the day after surgery
2 secondary outcomes
Pittsburgh sleep quality index (PSQI)
Time frame: 1 day after surgery
pain visual analogue scale scores
Time frame: The first 48 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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.
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 administration, Dexmedetomidine plus low-dose esketamine administration and Dexmedetomidine plus high-dose esketamine administration in people with Dexmedetomidine Plus Esketamine Affect Postoperative Sleep 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu si qi, Doctor (13865192106, errtg555@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index (PSQI) (time frame: the day after surgery). 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 16 May 2024.