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

Not Applicable

Recruiting

• Conditions: Morphine Consumption
• Interventions: Drug: Dexmedetomidine; Drug: placebo

• Registration Number: NCT04454515
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-01
• Study Start: 2021-04-20
• Status Verified: 2023-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	Dexmedetomidine	patient recieving dexmedetomidine
placebo	placebo	patients receiving placebo

Primary Outcome Measures

Name	Time	Method
morphine consumption	postoperative 7 days	postoperative morphine consumption by mg

Secondary Outcome Measures

Name	Time	Method
i-feed score	up to postoperative day 7	recovery of eating by I-feed questionare ( score: 0-14), minimum 0 (complete recovery without eating problems), maximum 14

Trial Locations

Locations (1)

National Taiwan University Cancer Center; 🇨🇳 Taipei, Taiwan