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CompletedNCT03868111Updated Jun 4, 2020

Sufentanil as Adjuvant of Balanced Anesthesia

An interventional study of Sufentanil and Remifentanil in Anesthesia, sponsored by Kangbuk Samsung Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Sufentanil

    Balanced anesthesia is maintained with 1 MAC desflurane and sufentanil during laparoscopic cholecystectomy.

    Drug: Sufentanil

  • Experimental
    Remifentanil

    Balanced anesthesia is maintained with 1 MAC desflurane and remifentanil during laparoscopic cholecystectomy.

    Drug: Remifentanil

Interventions

  • DrugSufentanil

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

    Also known as: Group S

  • DrugRemifentanil

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

    Also known as: Group R

06

What researchers measure

Primary outcomes

  1. Postoperative wound pain score

    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.

    Time frame: 10 minutes after surgery

07

Study locations

1 site
  • Kangbuk Samsung Hospital
    Seoul, 03181, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03868111
Lead sponsor
Kangbuk Samsung Hospital
Responsible party
Kyoung-Ho Ryu, MD (Assistant Professor, Kangbuk Samsung Hospital) — Principal investigator
First posted
Mar 8, 2019
Start date
Nov 4, 2019
Primary completion
Jan 12, 2020
Completion
Jan 12, 2020
Last update
Jun 4, 2020

Study contacts

Kyoung-Ho Ryu, M.D.
principal investigator · Kangbuk Samsung Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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