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The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy

Dexmedetomidine Combined With Esketamine Effects the Quality of Sleep

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06414941
Enrollment
105
Registered
2024-05-16
Start date
2024-05-15
Completion date
2024-10-20
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine Plus Esketamine Affect Postoperative Sleep Quality

Keywords

Esketamine, Sleep quality, Dexmedetomidine

Brief 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. 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.

Interventions

DRUGDexmedetomidine administration

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

DRUGDexmedetomidine plus low-dose esketamine administration

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.

DRUGDexmedetomidine plus high-dose esketamine administration

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.

Sponsors

Anqing Municipal Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅱ * Scheduled for elective modified radical mastectomy

Exclusion criteria

* Severe respiratory disease * Renal or hepatic insufficiency * History of preoperative psychiatric * Preoperative bradycardia * Preoperative atrioventricular block * Preoperative hypertension * BMI\>30

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh sleep quality index (PSQI)the day after surgeryOur primary outcome was Pittsburgh sleep quality index (PSQI) at the day after surgery

Secondary

MeasureTime frameDescription
Pittsburgh sleep quality index (PSQI)1 day after surgeryOur primary outcome was Pittsburgh sleep quality index (PSQI) on 1 day after surgery
pain visual analogue scale scoresThe first 48 hours after operationOur primary outcome was pain visual analogue scale scores

Countries

China

Contacts

Primary ContactXu si qi, Doctor
errtg555@163.com13865192106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026