Clinical trial NCT03756233: Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery
Official title: Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Rating Scale(NRS)
timeFrame: postoperative 1 hour
Secondary outcomes:
measure: SPI
timeFrame: intraoperative (after the laryngeal mask airway)
measure: SPI
timeFrame: intraoperative (after the incision)
measure: analgesics consumption
timeFrame: during post-anesthesia care unit
measure: analgesics consumption
timeFrame: up to postoperative 48hours
measure: nausea & vomiting
timeFrame: postoperative 1 hour
measure: Numeric Rating Scale(NRS)
timeFrame: during postoperative 48hours
measure: the duration of eye opening
timeFrame: end of surgery
measure: intraoperative remifentanil consumption
timeFrame: intraoperative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
Study officials:
affiliation: Samsung Medical Center
name: sehee kang, fellow
role: PRINCIPAL_INVESTIGATOR
References: