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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Remifentanil

• Registration Number: NCT03756233
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-25
• Study Start: 2018-11-26
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-28
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-03
• Last Update Submitted: 2019-09-08
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Remifentanil immediately stop group	Remifentanil	The control group stopped remifentanil 10 minutes before the end of the operation.
Remifentanil gradually withdrawal group	Remifentanil	20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes.

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale(NRS)	postoperative 1 hour	The difference of postoperative highest pain score (NRS) between two groups

Secondary Outcome Measures

Name	Time	Method
nausea & vomiting	postoperative 1 hour	The difference of nausea and vomiting between two groups
Numeric Rating Scale(NRS)	during postoperative 48hours	The difference of highest postoperative pain score (NRS) 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
SPI	intraoperative (after the incision)	The difference of Surgical Pleth Index between two groups
analgesics consumption	up to postoperative 48hours	The difference of analgesics consumption between two groups

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of