Morphine Consumption
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
DRUGplacebo
normal saline infusion
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind randomized study
Intervention model description
one group is going to receive precedex and another is placebo.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morphine consumption | postoperative 7 days | postoperative morphine consumption by mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| changes of OCTT (orocecal transit time) by minutes | preoperative and postoperative day 1 | 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 |
Countries
Taiwan
Contacts
Primary ContactYa-Jung Cheng, MD,PhD
Backup ContactChih-Jun Lai, MD
Outcome results
None listed