ED50 of Sufentanil for Intraoperative Analgesia

NCT06662656 | Not Yet Recruiting DMC

• 1 other identifier: CINI-AD-202403-13
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Sufentanil as an strong analgesic is used widespreadly during laparoscopic cholecystectomy.
2. 2.Lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect.
3. 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".

Conditions

Laparoscopic Cholecystectomy; Analgesics，Opioid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• visual analog scale score

  12 hours and 24hours after surgery

• The ratio of vomiting

  0 day, 1 day, 2 day after operation

• Systolic Blood Pressure

  0 day

• Dystolic Blood Pressure

  0 day

• Mean Blood Pressure

  0 day

Study Arms (6)

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.)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China International Neuroscience Institution: lead

Study Sites (1)

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

CN (1)