Back to resultsGradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Remifentanil gradually withdrawal group
Remifentanil immediately stop group
Arm Description
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.
Outcomes
Primary Outcome Measures
Numeric Rating Scale(NRS)
The difference of postoperative highest pain score (NRS) between two groups
Secondary Outcome Measures
SPI
The difference of Surgical Pleth Index between two groups
SPI
The difference of Surgical Pleth Index between two groups
analgesics consumption
The difference of analgesics consumption between two groups
analgesics consumption
The difference of analgesics consumption between two groups
nausea & vomiting
The difference of nausea and vomiting between two groups
Numeric Rating Scale(NRS)
The difference of highest postoperative pain score (NRS) between two groups
the duration of eye opening
the duration of eye opening after stoping propofol
intraoperative remifentanil consumption
the dose of intraoperative remifentanil according to postoperative pain
Full Information
NCT ID
NCT03756233
First Posted
October 25, 2018
Last Updated
September 8, 2019
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03756233
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remifentanil gradually withdrawal group
Arm Type
Active Comparator
Arm Description
20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes.
Arm Title
Remifentanil immediately stop group
Arm Type
Active Comparator
Arm Description
The control group stopped remifentanil 10 minutes before the end of the operation.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Rating Scale(NRS)
Description
The difference of postoperative highest pain score (NRS) between two groups
Time Frame
postoperative 1 hour
Secondary Outcome Measure Information:
Title
SPI
Description
The difference of Surgical Pleth Index between two groups
Time Frame
intraoperative (after the laryngeal mask airway)
Title
SPI
Description
The difference of Surgical Pleth Index between two groups
Time Frame
intraoperative (after the incision)
Title
analgesics consumption
Description
The difference of analgesics consumption between two groups
Time Frame
during post-anesthesia care unit
Title
analgesics consumption
Description
The difference of analgesics consumption between two groups
Time Frame
up to postoperative 48hours
Title
nausea & vomiting
Description
The difference of nausea and vomiting between two groups
Time Frame
postoperative 1 hour
Title
Numeric Rating Scale(NRS)
Description
The difference of highest postoperative pain score (NRS) between two groups
Time Frame
during postoperative 48hours
Title
the duration of eye opening
Description
the duration of eye opening after stoping propofol
Time Frame
end of surgery
Title
intraoperative remifentanil consumption
Description
the dose of intraoperative remifentanil according to postoperative pain
Time Frame
intraoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sehee kang, fellow
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery
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