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Clinical Trials/NCT04454515
NCT04454515
Recruiting
Not Applicable

The Effect of Intraoperative Dexmedetomidine on Postoperative Morphine Requirements and Oral Intake After Breast Cancer Surgery

National Taiwan University Hospital1 site in 1 country60 target enrollmentApril 20, 2021

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Morphine Consumption
Sponsor
National Taiwan University Hospital
Enrollment
60
Locations
1
Primary Endpoint
morphine consumption
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge. The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.

Detailed Description

Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge. The invetigators aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake. The participantss under general anesthesia and aged from 30 to 65 years old will be enrolled. All subjects were randomized into the dexmedetomidine or placebo group. They received placebo (group P, n = 30) or dexmedetomidine (loading dose of 1 μg kg-1 followed by 0.5 μg kg-1 h-1) (group D, n = 30) to the end of surgery. Data collected included intraoperative and postoperative opioid consumption. Postoperative questionare including PONV, Pain intensity, I-FEED questionnaire. Prospective analysis will be performed on the prospectively collected data. We expected to examine if intraoperative dexmedetomidine decreases the postoperative opioid consumption and associated complications, and enhances the gastrointestinal recovery and oral intake with narcotic-sparing effect.

Registry
clinicaltrials.gov
Start Date
April 20, 2021
End Date
July 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who fulfill the criteria of breast cancer under general anesthesia.

Exclusion Criteria

  • Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy.
  • Patients who have the risk of difficult ventilation or intubation.
  • Pregnant women.
  • Coagulopathy.

Arms & Interventions

dexmedetomidine

patient recieving dexmedetomidine

Intervention: Dexmedetomidine

placebo

patients receiving placebo

Intervention: placebo

Outcomes

Primary Outcomes

morphine consumption

Time Frame: postoperative 7 days

postoperative morphine consumption by mg

Secondary Outcomes

  • i-feed score(up to postoperative day 7)

Study Sites (1)

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