ED50 of Sufentanil for Intraoperative Analgesia

NCT ID: NCT06662656

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-01-30

Brief Summary

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".

Conditions

Laparoscopic Cholecystectomy; Analgesics，Opioid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1μg/ kg group

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.)

No interventions assigned to this group

0.83μg/ kg group

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.)

No interventions assigned to this group

0.69μg/ kg group

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.)

No interventions assigned to this group

0.58μg/ kg group

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.)

No interventions assigned to this group

0.48μg/ kg group

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.)

No interventions assigned to this group

0.4μg/ kg group

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.)

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China International Neuroscience Institution

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu hospital

Beijing, Beijing Municipality, China

Countries

China

Facility Contacts

Yanghai Cui, PHD

Role: primary

1055885750@qq.com

83199270 ext. 15010283592

Tianlong Wang, Doctor

Role: backup

w_tl5595@yeah.net

15910851623 ext. 15910851623

Other Identifiers

CINI-AD-202403-13

Identifier Type: OTHER

Identifier Source: secondary_id

CINI-AD-202403-13

Identifier Type: -

Identifier Source: org_study_id