ED50 of Sufentanil for Intraoperative Analgesia

China International Neuroscience Institution

Status: Not yet enrolling

Conditions: Analgesics，Opioid; Laparoscopic Cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06662656

CINI-AD-202403-13 (Other Identifier)

Details and patient eligibility

About

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".

Full 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".

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

26 participants in 6 patient groups

1μg/ kg group

Description:

Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. ( IOC2 values of \< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)

0.83μg/ kg group

Description:

Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 1/1.2=0.833 ( IOC2 values of \< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)

0.69μg/ kg group

Description:

Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 0.833/1.2=0.694( IOC2 values of \< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)

0.58μg/ kg group

Description:

Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 0.694/1.2=0.578( IOC2 values of \< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)

0.48μg/ kg group

Description:

Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 0.578/1.2=0.482( IOC2 values of \< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)

0.4μg/ kg group

Description:

Administration method of sufentanil: the dose of the first patient is 1μg / kg, and the ratio between adjacent doses is 1.2. 0.482/1.2=0.402( IOC2 values of \< 60, which were the target of this study, indicate adequate analgesic efect and analgesic level for regional surgery. IOC2 values of ≥ 60 indicate inadequate use of analgesics. If the analgesic effect of this patient is satisfactory, the next patient will use the lower dose. If the analgesic efect of this patient is not satisfactory, the next patient will use a higher dose. Starting from the first case of dissatisfaction, the number of observation units is counted. Dissatisfaction - satisfaction occurs at 7 exchange points and then the test ends.)