ED50 of Sufentanil for Intraoperative Analgesia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorChina International Neuroscience Institution
About this trial
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".
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA I ~ II level;
BMI22-30kg/m2;
Those who intend to undergo laparoscopic cholecystectomy;
Age 18~65 years.
Disqualifiers
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;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
26 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: 1μg/ kg group
Group B: 0.83μg/ kg group
Group C: 0.69μg/ kg group
Group D: 0.58μg/ kg group
Group E: 0.48μg/ kg group
Group F: 0.4μg/ kg group
Trial outcomes
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
Time frame
through study completion, an average of 1 daySecondary outcomes
1
visual analog scale score
visual analog scale (VAS) score at 12 h and 24 hours after operation,
Time frame
12 hours and 24hours after surgery2
The ratio of vomiting
the ratio of vomiting
Time frame
0 day, 1 day, 2 day after operation3
Systolic Blood Pressure
Systolic Blood Pressure reflect haemodynamics changeduring operation
Time frame
0 day4
Dystolic Blood Pressure
Dystolic Blood Pressure during operation
Time frame
0 daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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