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Sufentanil as Adjuvant of Balanced Anesthesia

Sponsor
Kangbuk Samsung Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03868111
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
2.3
Actual Duration (Months)
29.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant
Actual Study Start Date :
Nov 4, 2019
Actual Primary Completion Date :
Jan 12, 2020
Actual Study Completion Date :
Jan 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sufentanil

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

Drug: Sufentanil
The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
Other Names:
  • Group S

    		•
    Experimental: Remifentanil

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

    Drug: Remifentanil
    The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
    Other Names:
  • Group R

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative wound pain score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181

    Sponsors and Collaborators

    • Kangbuk Samsung Hospital

    Investigators

    • Principal Investigator: Kyoung-Ho Ryu, M.D., Kangbuk Samsung Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyoung-Ho Ryu, MD, Assistant Professor, Kangbuk Samsung Hospital
    ClinicalTrials.gov Identifier:
    NCT03868111
    Other Study ID Numbers:
    • 2019-02-001
    First Posted:
    Mar 8, 2019
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sufentanil
    Remifentanil

    Study Results

    No Results Posted as of Jun 4, 2020