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The Clinical Study of Dexmedetomidine and Esketamine Combined Infusion Undergoing Modified Radical Mastectomy

Primary Purpose

Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine infusion
Co-administration dexmedetomidine and low-dose esketamine infusion
Co-administration dexmedetomidine and high-dose esketamine infusion
Sponsored by
Anqing Municipal Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality focused on measuring Dexmedetomidine, esketamine, pain, recovery quality

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Anqing Hospital Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dexmedetomidine infusion on recovey quality with radical mastectomy

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

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Quality of recovery scores(QoR-15)
Our primary outcome was quality of recovery scores(QoR-15) 1 day after operation

Secondary Outcome Measures

Intraoperative remifentanil total dose
Secondary Outcome Measure was remifentanil total dose during the perioperative period
Pain visual analogue scale scores
Secondary Outcome Measure was pain visual analogue scale scores
incidence of PONV
Secondary Outcome Measure was incidence of PONV

Full Information

First Posted
March 8, 2022
Last Updated
April 11, 2023
Sponsor
Anqing Municipal Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05283408
Brief Title
The Clinical Study of Dexmedetomidine and Esketamine Combined Infusion Undergoing Modified Radical Mastectomy
Official Title
Effect of Dexmedetomidine and Esketamine Combined Infusion on Postoperative Pain and Recovey Quality Undergoing Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anqing Municipal Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Esketamine, Postoperative Pain and Recovery Quality
Keywords
Dexmedetomidine, esketamine, pain, recovery quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine infusion on recovey quality with radical mastectomy
Arm Type
Experimental
Arm Description
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
Arm Title
Co-administration dexmedetomidine and low-dose esketamine on recovey quality with radical mastectomy
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined dexmedetomidine and high-dose esketamine on recovey quality with radical mastectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine infusion
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Co-administration dexmedetomidine and low-dose esketamine infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Co-administration dexmedetomidine and high-dose esketamine infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of recovery scores(QoR-15)
Description
Our primary outcome was quality of recovery scores(QoR-15) 1 day after operation
Time Frame
1 day after operation
Secondary Outcome Measure Information:
Title
Intraoperative remifentanil total dose
Description
Secondary Outcome Measure was remifentanil total dose during the perioperative period
Time Frame
Intraoperative
Title
Pain visual analogue scale scores
Description
Secondary Outcome Measure was pain visual analogue scale scores
Time Frame
The first 48 hours after operation
Title
incidence of PONV
Description
Secondary Outcome Measure was incidence of PONV
Time Frame
The first 48 hours after operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anqing Hospital Anesthesiology
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246000
Country
China

12. IPD Sharing Statement

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The Clinical Study of Dexmedetomidine and Esketamine Combined Infusion Undergoing Modified Radical Mastectomy

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