Laparoscopic CholecystectomyED50NCT06662656
ED50 of Sufentanil for Intraoperative Analgesia
An observational study of Laparoscopic Cholecystectomy and Analgesics，Opioid, run by China International Neuroscience Institution at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Analgesics，Opioid
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 30 Jan 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ASA I ~ II level;
- BMI22-30kg/m2;
- Those who intend to undergo laparoscopic cholecystectomy;
- Age 18~65 years.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu hospital
Beijing, Beijing Municipality, 100053
Yanghai Cui, PHD, 83199270 ext. 15010283592, 1055885750@qq.com
Tianlong Wang, Doctor, 15910851623 ext. 15910851623, w_tl5595@yeah.net
About this study
Official title: ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy
- Sufentanil as an strong analgesic is used widespreadly during laparoscopic cholecystectomy.
- Lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect.
- 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".
Read the 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".
- Conditions
- Laparoscopic Cholecystectomy, Analgesics，Opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The rate of the IOC2 target a reachment
The primary endpoint of the study was the attainment rate of the IOC2 target during operation
Measured: through study completion, an average of 1 day
Secondary outcomes (6)
visual analog scale score
visual analog scale (VAS) score at 12 h and 24 hours after operation,
Measured: 12 hours and 24hours after surgery
The ratio of vomiting
the ratio of vomiting
Measured: 0 day, 1 day, 2 day after operation
Systolic Blood Pressure
Systolic Blood Pressure reflect haemodynamics changeduring operation
Measured: 0 day
Dystolic Blood Pressure
Dystolic Blood Pressure during operation
Measured: 0 day
Mean Blood Pressure
Mean Blood Pressure during opeation
Measured: 0 day
Heart rate
Heart rate during operation
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662656
- Sponsor's protocol ID
- CINI-AD-202403-13
- Other IDs
- CINI-AD-202403-13
- Acronym
- ED50
- Status last verified
- Oct 2024
- First submitted
- 17 Mar 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED50 of Sufentanil with Dexmedetomidine Analgesia During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06662656
- Acronym / sponsor ID
- ED50 / CINI-AD-202403-13
- Conditions
- Laparoscopic Cholecystectomy, Analgesics，Opioid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Sufentanil as an strong analgesic is used widespreadly during laparoscopic cholecystectomy.
- Lower dosages of sufentanil facilitated with dexmedetomidine can offer enough analgesia effect.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ASA I ~ II level;
- BMI22-30kg/m2;
- Those who intend to undergo laparoscopic cholecystectomy;
- Age 18~65 years.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of the IOC2 target a reachment
Time frame: through study completion, an average of 1 day
The primary endpoint of the study was the attainment rate of the IOC2 target during operation
6 secondary outcomes
visual analog scale score
Time frame: 12 hours and 24hours after surgery
The ratio of vomiting
Time frame: 0 day, 1 day, 2 day after operation
Systolic Blood Pressure
Time frame: 0 day
Dystolic Blood Pressure
Time frame: 0 day
Mean Blood Pressure
Time frame: 0 day
Heart rate
Time frame: 0 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy and Analgesics，Opioid, run by China International Neuroscience Institution at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of the IOC2 target a reachment (time frame: through study completion, an average of 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.