Sufentanil as Adjuvant of Balanced Anesthesia
Comparison Between Sufentanil and Remifentanil as General Anesthetic Adjuvant
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedStudy Start
First participant enrolled
November 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2020
CompletedJune 4, 2020
June 1, 2020
2 months
March 6, 2019
June 2, 2020
Conditions
Outcome Measures
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.
10 minutes after surgery
Study Arms (2)
Sufentanil
EXPERIMENTALBalanced anesthesia is maintained with 1 MAC desflurane and sufentanil during laparoscopic cholecystectomy.
Remifentanil
EXPERIMENTALBalanced anesthesia is maintained with 1 MAC desflurane and remifentanil during laparoscopic cholecystectomy.
Interventions
The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyoung-Ho Ryu, M.D.
Kangbuk Samsung Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 6, 2019
First Posted
March 8, 2019
Study Start
November 4, 2019
Primary Completion
January 12, 2020
Study Completion
January 12, 2020
Last Updated
June 4, 2020
Record last verified: 2020-06