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NCT Number: NCT06260046

Effect of Sufentanil on the Postoperative Pain

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location contact

Chang-Hoon Koo

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil

Drug

Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml

Remifentanil

Drug

Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml

Primary outcomes

  1. opioid consumption

    Time frame: During post-anesthesia care unit(PACU) stay, until 1 hour

Secondary outcomes

  1. Richmond Agitation-Sedation scale

    Time frame: 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

  2. Incidence of postoperative nausea and vomiting

    Time frame: During post-anesthesia care unit(PACU) stay, until 1 hour

  3. Number of patients who administered antiemetics

    Time frame: During post-anesthesia care unit(PACU) stay, until 1 hour

    ramosetron will be administered as antiemetics

  4. Pain score

    Time frame: immediately after surgery, 15minutes, 30minutes, 60minutes after surgery

    Numeric rating scale (0=none, 10=extremely pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Chang-Hoon Koo

CONTACT

[email protected]

+821085098841

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Analgesic Effect of Intraoperative Sufentanil on Postoperative Pain in Patients Undergoing Robot-assisted Nephrectomy: a Prospective Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Feb 15, 2024
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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