Sufentanil as Adjuvant of Balanced Anesthesia

June 2, 2020 updated by: Kyoung-Ho Ryu, MD, Kangbuk Samsung Hospital

Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 4, 2019

Primary Completion (ACTUAL)

January 12, 2020

Study Completion (ACTUAL)

January 12, 2020

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (ACTUAL)

March 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-02-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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