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ED50 of Sufentanil for Intraoperative Analgesia

ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06662656
Acronym
ED50
Enrollment
26
Registered
2024-10-29
Start date
2024-11-01
Completion date
2025-01-30
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesics,Opioid, Laparoscopic Cholecystectomy

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.

Interventions

None listed

Sponsors

China International Neuroscience Institution
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The rate of the IOC2 target a reachmentthrough study completion, an average of 1 dayThe primary endpoint of the study was the attainment rate of the IOC2 target during operation

Secondary

MeasureTime frameDescription
The ratio of vomiting0 day, 1 day, 2 day after operationthe ratio of vomiting
Systolic Blood Pressure0 daySystolic Blood Pressure reflect haemodynamics changeduring operation
visual analog scale score12 hours and 24hours after surgeryvisual analog scale (VAS) score at 12 h and 24 hours after operation,
Mean Blood Pressure0 dayMean Blood Pressure during opeation
Heart rate0 dayHeart rate during operation
Dystolic Blood Pressure0 dayDystolic Blood Pressure during operation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026