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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Drug: Sufentanil; Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang-Hoon Koo; Phone Number: +821085098841; Email: vollock9@gmail.com

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
    • Contact: Chang-Hoon Koo; Email: vollock9@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who undergo elective robot-assisted nephrectomy surgery
• American Society of Anesthesiologists grade 1,2,3
• Age > 18 years old

Exclusion Criteria:

• Refuse to participate to the study
• Allergic history of opioid
• chronic pain
• opioid user before surgery
• MAO inhibitor user
• Severe respiratory insufficiency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sufentanil group; sufentanil is administered for analgesic during general anesthesia	Drug: Sufentanil; Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml
Active Comparator: remifentanil group; remifentanil is administered for analgesic during general anesthesia	Drug: Remifentanil; Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
opioid consumption	During post-anesthesia care unit(PACU) stay, until 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richmond Agitation-Sedation scale	(+4), Combative, Overtly combative or violent; immediate danger to staff (+3), Very agitated, Pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff (+2), Agitated, Frequent nonpurposeful movement or patient-ventilator dyssynchrony (+1), Restless, Anxious or apprehensive but movements not aggressive or vigorous 0, Alert and calm, Spontaneously pays attention to caregiver (-1), Drowsy, Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice (-2), Light sedation, Briefly (less than 10 seconds) awakens with eye contact to voice (-3), Moderate sedation, Any movement (but no eye contact) to voice (-4), Deep sedation, No response to voice, but any movement to physical stimulation (-5), Unarousable, No response to voice or physical stimulation	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	ramosetron will be administered as antiemetics	During post-anesthesia care unit(PACU) stay, until 1 hour
Pain score	Numeric rating scale (0=none, 10=extremely pain)	immediately after surgery, 15minutes, 30minutes, 60minutes after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chang-Hoon Koo, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Sufentanil
• Other Study ID Numbers: Robot Nx-SFTN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No