Effect of Sufentanil on the Postoperative Pain

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain, Acute
• Interventions: Drug: Sufentanil; Drug: Remifentanil

• Registration Number: NCT06260046
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-26
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Study Start: 2024-03-01
• Primary Completion: 2025-01-15
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sufentanil group	Sufentanil	sufentanil is administered for analgesic during general anesthesia
remifentanil group	Remifentanil	remifentanil is administered for analgesic during general anesthesia

Primary Outcome Measures

Name	Time	Method
opioid consumption	During post-anesthesia care unit(PACU) stay, until 1 hour

Secondary Outcome Measures

Name	Time	Method
Pain score	immediately after surgery, 15minutes, 30minutes, 60minutes after surgery	Numeric rating scale (0=none, 10=extremely pain)
Richmond Agitation-Sedation scale	During post-anesthesia care unit(PACU) stay, until 1 hour	(+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
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	ramosetron will be administered as antiemetics

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of