ED50 of Sufentanil for Intraoperative Analgesia (ED50)

ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy

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".

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Cholecystectomy; Analgesics，Opioid

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".

• Study Type: Observational
• Enrollment (Estimated): 26

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital
      • Contact: Yanghai Cui, PHD; Phone Number: 15010283592 83199270; Email: 1055885750@qq.com
      • Contact: Tianlong Wang, Doctor; Phone Number: 15910851623 15910851623; Email: w_tl5595@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients in Xuanwu Hospital for elective laparoscopic cholecystectomy are selected. Before surgery, visitors recorded basic information such as the patient's sex, age, BMI, ASA grade in the ward.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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.)
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.)
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.)
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.)
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.)
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of the IOC2 target a reachment	The primary endpoint of the study was the attainment rate of the IOC2 target during operation	through study completion, an average of 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale score	visual analog scale (VAS) score at 12 h and 24 hours after operation,	12 hours and 24hours after surgery
The ratio of vomiting	the ratio of vomiting	0 day, 1 day, 2 day after operation
Systolic Blood Pressure	Systolic Blood Pressure reflect haemodynamics changeduring operation	0 day
Dystolic Blood Pressure	Dystolic Blood Pressure during operation	0 day
Mean Blood Pressure	Mean Blood Pressure during opeation	0 day
Heart rate	Heart rate during operation	0 day

Collaborators and Investigators

• Sponsor: China International Neuroscience Institution

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: October 27, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 27, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CINI-AD-202403-13 (Other Identifier: XuanWu Hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No