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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Morphine Consumption
• Intervention / Treatment: Drug: placebo; Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Jung Cheng, MD,PhD; Phone Number: 23220322; Email: chengyj@ntu.edu.tw
• Study Contact Backup: Name: Chih-Jun Lai, MD; Phone Number: 62158 23123456; Email: littlecherrytw@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 106
    • Recruiting
    • National Taiwan University Cancer Center
    • Contact: Yajung Cheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	postoperative morphine consumption by mg	postoperative 7 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of OCTT (orocecal transit time) by minutes	detect the hydrogen in exhaled gas every 15 minutes after drinking 10 gram lactulose. The time with hydrogen production more than 10 ppm is the OCTT. The changes of OCTT time between pre-operation and POD1	preoperative and postoperative day 1

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 202004120MINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: due to the ethical concern, we did not share our paatients' data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No