ED50 of Sufentanil for Intraoperative Analgesia

Not yet recruiting

• Conditions: Laparoscopic Cholecystectomy; Analgesics，Opioid

• Registration Number: NCT06662656
• Lead Sponsor: China International Neuroscience Institution

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".

Study Timeline

• Study First Submitted: 2024-03-17
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-27
• Last Update Submitted: 2024-10-27
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Study Start: 2024-11-01
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of the IOC2 target a reachment	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 Outcome Measures

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

Trial Locations

Locations (1)

Xuanwu hospital; 🇨🇳 Beijing, Beijing, China