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Completed

NCT Number: NCT03868111

Sufentanil as Adjuvant of Balanced Anesthesia

The aim of the study was to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced general anesthesia.

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Key information

Conditions

Anesthesia

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

About this study

The investigators hypothesized that sufentanil would reduce postoperative pain than remifentanil without prolonging recovery times in minor laparoscopic surgery when administered equivalent antinociceptive doses during surgery. Intraoperative opioid administration for equivalent nociception-antinociception balance could be achieved via surgical pleth index (SPI)-guided analgesia. This study was designed to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced anesthesia in patients undergoing laparoscopic cholecystectomy under SPI-guided opioid administration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 19 and 65 years
  • Patients with American Society of Anesthesiologists physical status I or II
  • Patients scheduled for elective laparoscopic cholecystectomy under balanced general anesthesia for benign cholecystic diseases
  • Patients obtaining written informed consent

Exclusion criteria

  • Patients with asthma or hypertension
  • Patients with an inability to express their pain accurately
  • Patients with an inability to understand the pain scale
  • Patients with chronic abdominal pain or chronic pain syndrome
  • Patients who required to convert to laparotomy from laparoscopic surgery
  • Patients who required to receive incidental lower abdominal procedures owing to adhesion, injury, or other incidental findings at the lower abdominal cavity
  • Patients with a history of drug or alcohol abuse
  • Pregnant women

Treatment and study plan

Sufentanil

Drug

The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.

Other names: Group S

Remifentanil

Drug

The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.

Other names: Group R

Primary outcomes

  1. Postoperative wound pain score

    Time frame: 10 minutes after surgery

    The pain score is evaluated by 10 point visual analogue scale at post-anesthesia care unit. The visual analogue scale is presented as a 10-cm line with verbal descriptors indicating "no pain" and "pain as bad as it could be". The visual analogue scale ranges from 0 to 10, representing minimum and maximum pain levels, respectively.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2019
Registry last updated
Jun 4, 2020

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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