Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414941
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-09
Brief Title:
The Effect of Dexmedetomidine and Esketamine Combined Infusion Quality of Sleep Undergoing Modified Radical Mastectomy
Sponsor:
Anqing Municipal Hospital
Organization:
Anqing Municipal Hospital
Study Overview
Official Title:
Dexmedetomidine Combined With Esketamine Effects the Quality of Sleep
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 µgkg over 10 min before the induction of anesthesia and then dexmedetomidine was infused at a rate of 04 μgkgh until 20 min before the end of operation Patients in group DE1 received a bolus infusion of dexmedetomidine 05 µgkg and esketamine 05 mgkgover 10 min before the induction of anesthesia and then dexmedetomidine were infused at a rate of 04 µgkgh and 2 µgkgmin until 20 min before the end of operation respectively Patients in group DE2 received received a bolus infusion of dexmedetomidine 05 µgkg and esketamine 05 mgkgover 10 min before the induction of anesthesia and then dexmedetomidine were infused at a rate of 04 µgkgh and 4 µgkgmin 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
METHODS One hundred and five women with elective modified radical mastectomy were randomly divided into 3 groups Patients in group D received dexmedetomidine 05 µgkg over 10 min before the induction of anesthesia and then dexmedetomidine was infused at a rate of 04 μgkgh until 20 min before the end of operation Patients in group DE1 received a bolus infusion of dexmedetomidine 05 µgkg and esketamine 05 mgkgover 10 min before the induction of anesthesia and then dexmedetomidine were infused at a rate of 04 µgkgh and 2 µgkgmin until 20 min before the end of operation respectively Patients in group DE2 received received a bolus infusion of dexmedetomidine 05 µgkg and esketamine 05 mgkgover 10 min before the induction of anesthesia and then dexmedetomidine were infused at a rate of 04 µgkgh and 4 µgkgmin 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None