Effect of Sufentanil on the Postoperative Pain
Analgesic Effect of Intraoperative Sufentanil on Postoperative Pain in Patients Undergoing Robot-assisted Nephrectomy: a Prospective Randomized Controlled Trial
1 other identifier
interventional
48
1 country
1
Brief Summary
This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration 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
December 26, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2027
ExpectedFebruary 15, 2024
February 1, 2024
11 months
December 26, 2023
February 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
opioid consumption
During post-anesthesia care unit(PACU) stay, until 1 hour
Secondary Outcomes (4)
Richmond Agitation-Sedation scale
During post-anesthesia care unit(PACU) stay, until 1 hour
Incidence of postoperative nausea and vomiting
During post-anesthesia care unit(PACU) stay, until 1 hour
Number of patients who administered antiemetics
During post-anesthesia care unit(PACU) stay, until 1 hour
Pain score
immediately after surgery, 15minutes, 30minutes, 60minutes after surgery
Study Arms (2)
sufentanil group
EXPERIMENTALsufentanil is administered for analgesic during general anesthesia
remifentanil group
ACTIVE COMPARATORremifentanil is administered for analgesic during general anesthesia
Interventions
Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml
Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml
Eligibility Criteria
You may qualify if:
- Patients who undergo elective robot-assisted nephrectomy surgery
- American Society of Anesthesiologists grade 1,2,3
- Age \> 18 years old
You may not qualify if:
- Refuse to participate to the study
- Allergic history of opioid
- chronic pain
- opioid user before surgery
- MAO inhibitor user
- Severe respiratory insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chang-Hoon Koo
Seoul National University Bundang Hospital
Central Study Contacts
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
December 26, 2023
First Posted
February 15, 2024
Study Start
March 1, 2024
Primary Completion
January 15, 2025
Study Completion (Estimated)
January 15, 2027
Last Updated
February 15, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share