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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Remifentanil

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 06351
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remifentanil gradually withdrawal group; 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes.	Drug: Remifentanil; 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.
Active Comparator: Remifentanil immediately stop group; The control group stopped remifentanil 10 minutes before the end of the operation.	Drug: Remifentanil; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale(NRS)	The difference of postoperative highest pain score (NRS) between two groups	postoperative 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPI	The difference of Surgical Pleth Index between two groups	intraoperative (after the laryngeal mask airway)
SPI	The difference of Surgical Pleth Index between two groups	intraoperative (after the incision)
analgesics consumption	The difference of analgesics consumption between two groups	during post-anesthesia care unit
analgesics consumption	The difference of analgesics consumption between two groups	up to postoperative 48hours
nausea & vomiting	The difference of nausea and vomiting between two groups	postoperative 1 hour
Numeric Rating Scale(NRS)	The difference of highest postoperative pain score (NRS) between two groups	during postoperative 48hours
the duration of eye opening	the duration of eye opening after stoping propofol	end of surgery
intraoperative remifentanil consumption	the dose of intraoperative remifentanil according to postoperative pain	intraoperative

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: sehee kang, fellow, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 3, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 8, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: SMC2018-07-153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No