Pain, Postoperative
Conditions
Brief summary
Although remifentanil provides profound analgesia during operation, postoperative occurrence of hyperalgesia and tolerance after remifentanil administration could be a challenge to the postoperative pain control. Evaluation of analgesia and anti-nociception during anesthesia is still a challenging issue. Surgical Pleth Index (SPI) is a non-invasive and simple access tool used to monitor autonomous nervous system during anesthesia. This technique is based on photoplethysmographic wave and heart beat analysis. SPI values range between 0 (no stress) and 100 (high stress level). The purpose of this study was to determine the appropriate use of Remifentanil for pain control in patients with SPI.
Detailed description
Patients were randomized into either SPI-guided analgesia or standard practice (Control). In both groups, anesthesia was maintained with total intravenous anaesthesia(TIVA) to keep bispectral index values between 40 and 60. In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group stopped remifentanil 10 minutes before the end of the operation. SPI was recorded before the intubation, after the intubation, directly before the end of surgery. The number of unwanted somatic events, hemodynamics, Patient-controlled analgesia(PCA) consumption, narcotic analgesics consumption, and recovery times were recorded.
Interventions
DRUGRemifentanil
Remifentanil is a potent, short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anesthetic.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
In this study, remifentanil gradually withdrawal goup (test group) and remifentanil immediately stop group (control group) were divided into two groups. In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group stopped remifentanil 10 minutes before the end of the operation.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who received the breast conserving surgery
Exclusion criteria
* Patients with arrhythmia who have poor SPI measurement * When the patient refused * Patients with decreased renal function of Cr\> 2 * Surgery for more than 3 hours, surgery expected to bleed more than 500 ml
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale(NRS) | postoperative 1 hour | The difference of postoperative highest pain score (NRS) between two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| analgesics consumption | during post-anesthesia care unit | The difference of analgesics consumption between two groups |
| nausea & vomiting | postoperative 1 hour | The difference of nausea and vomiting between two groups |
| SPI | intraoperative (after the laryngeal mask airway) | The difference of Surgical Pleth Index between two groups |
| the duration of eye opening | end of surgery | the duration of eye opening after stoping propofol |
| intraoperative remifentanil consumption | intraoperative | the dose of intraoperative remifentanil according to postoperative pain |
| Numeric Rating Scale(NRS) | during postoperative 48hours | The difference of highest postoperative pain score (NRS) between two groups |
Countries
South Korea
Outcome results
None listed