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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756233
• Other study ID #: SMC2018-07-153
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: July 3, 2019

Study information

• Verified date: October 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 3, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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