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

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StatusNot yet recruiting
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National Taiwan University Hospital

Keywords

Abstract

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. We aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.

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.

We aimed to compare the effects of dexmedetomidine infusion versus placebo on postoperative narcotics requirement, complications, and oral intake.

Our patients 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.

Dates

Last Verified: 05/31/2020
First Submitted: 06/28/2020
Estimated Enrollment Submitted: 06/29/2020
First Posted: 06/30/2020
Last Update Submitted: 06/29/2020
Last Update Posted: 06/30/2020
Actual Study Start Date: 07/02/2020
Estimated Primary Completion Date: 06/30/2023
Estimated Study Completion Date: 06/30/2025

Condition or disease

Morphine Consumption

Intervention/treatment

Drug: dexmedetomidine

Drug: placebo

Phase

-

Arm Groups

ArmIntervention/treatment
Experimental: dexmedetomidine
patient recieving dexmedetomidine
Drug: dexmedetomidine
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.
Placebo Comparator: placebo
patients receiving placebo
Drug: placebo
normal saline infusion

Eligibility Criteria

Ages Eligible for Study 20 Years To 20 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
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.

Outcome

Primary Outcome Measures

1. morphine consumption [postoperative 7 days]

To examine if intraoperative dexmedetomidine decreases the postoperative opioid consumption

Secondary Outcome Measures

1. I-feeding score [postoperative 7 days]

recovery of gastrointestinal function

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