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Completed

NCT Number: NCT03756233

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Numeric Rating Scale(NRS)

    Time frame: postoperative 1 hour

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

Secondary outcomes

  1. SPI

    Time frame: intraoperative (after the laryngeal mask airway)

    The difference of Surgical Pleth Index between two groups

  2. SPI

    Time frame: intraoperative (after the incision)

    The difference of Surgical Pleth Index between two groups

  3. analgesics consumption

    Time frame: during post-anesthesia care unit

    The difference of analgesics consumption between two groups

  4. analgesics consumption

    Time frame: up to postoperative 48hours

    The difference of analgesics consumption between two groups

  5. nausea & vomiting

    Time frame: postoperative 1 hour

    The difference of nausea and vomiting between two groups

  6. Numeric Rating Scale(NRS)

    Time frame: during postoperative 48hours

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

  7. the duration of eye opening

    Time frame: end of surgery

    the duration of eye opening after stoping propofol

  8. intraoperative remifentanil consumption

    Time frame: intraoperative

    the dose of intraoperative remifentanil according to postoperative pain

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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