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

NCT04454515 | Unknown DMC

• 1 other identifier: 202004120MINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Morphine Consumption

Outcome Measures

Primary Outcomes (1)

• morphine consumption

  postoperative morphine consumption by mg

  postoperative 7 days

Secondary Outcomes (1)

• i-feed score

  up to postoperative day 7

Other Outcomes (1)

• changes of OCTT (orocecal transit time) by minutes

  preoperative and postoperative day 1

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

patient recieving dexmedetomidine

Drug: Dexmedetomidine

placebo

PLACEBO COMPARATOR

patients receiving placebo

Drug: placebo

Interventions

Dexmedetomidine DRUG

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.

dexmedetomidine

placebo DRUG

normal saline infusion

placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Cancer Center

Taipei, 106, Taiwan

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ya-Jung Cheng, MD,PhD

CONTACT

23220322; chengyj@ntu.edu.tw

Chih-Jun Lai, MD

CONTACT

23123456; littlecherrytw@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind randomized study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group is going to receive precedex and another is placebo.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 1, 2020
• Study Start: April 20, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: January 17, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)