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NCT Number: NCT06662656

ED50 of Sufentanil for Intraoperative Analgesia

1. Sufentanil as an strong analgesic is used widespreadly during laparoscopic cholecystectomy. 2. Lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect. 3. The investigator are planning use the most classical method for determining the ED50 or half effective concentration of sufentanil facilitated with dexmedetomidine using sequential method, which is also called" up and down method" and" ladder method".

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The concordance of the current research is that lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect through operation. However, the dosages of sufentanil used in various researches vary greatly of operations. Previous studies have shown that the amount of sufentanil required for intraoperative analgesia is smaller than that required while dexmedetomindine facilitated. Although the appropriate dosage of sufentanil required for operation can ensure the analgesic effect of operation, excessive dosage can cause severe choking during intubation, postoperative nausea and vomiting, hyperalgesia, and chronic postoperative pain. The investigator planning use the most classical method for determining the ED50 or half effective concentration of sufentainl combined with dexmedetomidine using sequential method, which is also called " up and down method" and " ladder method".

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA I ~ II level;
  • BMI22-30kg/m2;
  • Those who intend to undergo laparoscopic cholecystectomy;
  • Age 18~65 years.

Exclusion criteria

  • Has been allergic to the drugs used in this study;
  • Patients with a history of chronic use of alcohol, smoke or other sedative drugs;
  • Patients took opioids and other analgesics before surgery;
  • Emergency operation;
  • Stress, anxiety resulting in secretion of catecholamine;
  • Patients with neuropsychiatric disorders, coma, depression, cognitive impairment and Alzheimer's disease;
  • Patients with epilepsy, autonomic nervous dysfunction and other diseases with abnormal EEG results;
  • SBP< 85 mmHg or HR< 45次/min;
  • Has implanted pacemaker;
  • Patients were unwilling or disable to finish whole study;
  • Patients with acute upper respiratory infections, liver or kidney failure and severe cardiopulmonary dysfunction.

Treatment and study plan

Primary outcomes

  1. The rate of the IOC2 target a reachment

    Time frame: through study completion, an average of 1 day

    The primary endpoint of the study was the attainment rate of the IOC2 target during operation

Secondary outcomes

  1. visual analog scale score

    Time frame: 12 hours and 24hours after surgery

    visual analog scale (VAS) score at 12 h and 24 hours after operation,

  2. The ratio of vomiting

    Time frame: 0 day, 1 day, 2 day after operation

    the ratio of vomiting

  3. Systolic Blood Pressure

    Time frame: 0 day

    Systolic Blood Pressure reflect haemodynamics changeduring operation

  4. Dystolic Blood Pressure

    Time frame: 0 day

    Dystolic Blood Pressure during operation

  5. Mean Blood Pressure

    Time frame: 0 day

    Mean Blood Pressure during opeation

  6. Heart rate

    Time frame: 0 day

    Heart rate during operation

Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study title

ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy

Acronym: ED50

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Oct 29, 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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