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

Morphine Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04454515
• Other study ID #: 202004120MINB
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2023
• Source: National Taiwan University Hospital
• Contact: Ya-Jung Cheng, MD,PhD
• Phone: 23220322
• Email: chengyj[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morphine Consumption

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine is an a2 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
normal saline infusion

Locations

Country	Name	City	State
Taiwan	National Taiwan University Cancer Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	morphine consumption	postoperative morphine consumption by mg	postoperative 7 days
Secondary	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