ED50 of Sufentanil for Intraoperative Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Laparoscopic Cholecystectomy, Analgesics，Opioid. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy
Overview
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".
Detailed description
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".
Primary outcome measures
- The rate of the IOC2 target a reachment [Time frame: through study completion, an average of 1 day]
Secondary outcome measures (6)
- visual analog scale score [Time frame: 12 hours and 24hours after surgery]
- The ratio of vomiting [Time frame: 0 day, 1 day, 2 day after operation]
- Systolic Blood Pressure [Time frame: 0 day]
- Dystolic Blood Pressure [Time frame: 0 day]
- Mean Blood Pressure [Time frame: 0 day]
- Heart rate [Time frame: 0 day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xuanwu hospital — Beijing
Identifiers
NCT: NCT06662656 · CINI-AD-202403-13 · CINI-AD-202403-13