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Clinical Trials/NCT03756233
NCT03756233
Completed
Not Applicable

Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery

Samsung Medical Center1 site in 1 country60 target enrollmentNovember 26, 2018

Overview

Phase
Not Applicable
Intervention
Remifentanil
Conditions
Pain, Postoperative
Sponsor
Samsung Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Numeric Rating Scale(NRS)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
July 3, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Remifentanil gradually withdrawal group

20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes.

Intervention: Remifentanil

Remifentanil immediately stop group

The control group stopped remifentanil 10 minutes before the end of the operation.

Intervention: Remifentanil

Outcomes

Primary Outcomes

Numeric Rating Scale(NRS)

Time Frame: postoperative 1 hour

The difference of postoperative highest pain score (NRS) between two groups

Secondary Outcomes

  • nausea & vomiting(postoperative 1 hour)
  • Numeric Rating Scale(NRS)(during postoperative 48hours)
  • the duration of eye opening(end of surgery)
  • intraoperative remifentanil consumption(intraoperative)
  • SPI(intraoperative (after the incision))
  • analgesics consumption(up to postoperative 48hours)

Study Sites (1)

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