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

NCT03756233 | Completed

• 1 other identifier: SMC2018-07-153
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale(NRS)

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

  postoperative 1 hour

Secondary Outcomes (8)

• SPI

  intraoperative (after the laryngeal mask airway)

• SPI

  intraoperative (after the incision)

• analgesics consumption

  during post-anesthesia care unit

• analgesics consumption

  up to postoperative 48hours

• nausea & vomiting

  postoperative 1 hour

Study Arms (2)

Remifentanil gradually withdrawal group

ACTIVE COMPARATOR

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

Drug: Remifentanil

Remifentanil immediately stop group

ACTIVE COMPARATOR

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

Drug: Remifentanil

Interventions

Remifentanil DRUG

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.

Remifentanil gradually withdrawal group; Remifentanil immediately stop group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received the breast conserving surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• sehee kang, fellow

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 28, 2018
• Study Start: November 26, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 3, 2019
• Last Updated: September 11, 2019

Record last verified: 2018-10

Locations

KR (1)