AnesthesiaDEXCOEURNCT06082856
Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery
A study testing Dexmedetomidine and Sufentanil in people with Anesthesia and Dexmedetomidine, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Ambulatory surgery is increasingly used in anesthesia. In case of general anesthesia, it is recommended to use anesthesia molecules with a short half-life and low doses of opiates to ensure a rapid awakening and to prevent nausea and vomiting by systematic administration of anti-emetics during the operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Dexmedetomidine, Hemodynamics
- What is being tested?
- Dexmedetomidine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2023to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with scheduled surgery under general anesthesia for one of the following: oral, orthopedic, urological, digestive and gynecological surgeries.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is in a period of exclusion determined by a previous study
- The subject is unable to give consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient with a known allergy to dexmedetomidine or other drugs.
- Patient with a contraindication to general anesthesia or outpatient management.
Show all 12Show fewer
- Patient treated with beta-blocker, ACE inhibitor or ARB2
- Patient with an ASA4 score.
- Patient with HR < 50 bpm.
- Patient with the following cardiovascular comorbidities: coronary insufficiency, obstructive cardiomyopathy, severe hypertension, ventricular rhythm or conduction disorder.
- Patient with hepatic (prothrombin rate < 70%, liver enzyme/Bilirubin X 3) and/or renal (clearance < 50 ml.min) insufficiency.
- Pregnant, parturient or nursing patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Yann GRICOURT
About this study
Official title: Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery: Single-center Prospective Randomized Double-blind Non-inferiority Study.
Ambulatory surgery is increasingly used in anesthesia. In case of general anesthesia, it is recommended to use anesthesia molecules with a short half-life and low doses of opiates to ensure a rapid awakening and to prevent nausea and vomiting by systematic administration of anti-emetics during the operation.
Opiates (including sufentanil) have recently been called into question because of the nausea and vomiting and the delay in waking up induced by these molecules. To combat these side effects, the authors have proposed either to reduce the doses or to substitute them with dexmedetomidine, a sedative antihypertensive drug. Recent studies have demonstrated that opiates used in general anesthesia can be replaced by dexmedetomidine. However, literature data are controversial concerning the hemodynamic impact. No study has compared the hemodynamic profile of opioid-free anesthesia with dexmedetomidine versus conventional anesthesia with opioids.
Read more
The ambulatory context lends itself to the use of dexmedetomidine because it is aimed at a population without strong cardiac pathology, concerns non-major interventions, with the need to optimize pain and side effects.
The study authors therefore wish to compare the effects of induction of general anesthesia with low-dose Dexmedetomidine versus sufentanil, on post-induction hemodynamic stability in scheduled outpatient surgeries. The investigators hypothesize that hemodynamic stability at induction of general anesthesia with low-dose dexmedetomidine is not inferior to that obtained with sufentanil in scheduled ambulatory surgeries.
- Conditions
- Anesthesia, Dexmedetomidine, Hemodynamics, Ambulatory Care
- Being tested
- Dexmedetomidine, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Induction of general anesthesia by administration of dexmedetomidine 0.5µg/Kg (maximum dose 50 µg) in titration by bolus of 10µg intravenously over 5 minutes
SufentanilDrug
Induction of general anesthesia by administration of sufentanil 0.25µg/Kg (maximum dose 20 µg) intravenously at anesthetic induction.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Sufentanil | Active comparator | Not described Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hemodynamic stability during anesthesia between groups
Incidence of mean arterial pressure < 60 mmHg
Measured: Within 60 minutes after induction
Secondary outcomes (19)
Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups
Percentage of patients with 30% change in mean arterial pressure from baseline
Measured: Within 60 minutes after induction
Intraoperative heart rate between groups
Percentage of patients with bradycardia ≤45bpm/min
Measured: Within 60 minutes after induction
Intraoperative hypertensive episodes between groups
Percentage of patients with at least one episode of arterial hypertension (mean arterial pressure > 100mmHg)
Measured: Within 60 minutes after induction
Hemodynamic stability in the ICU between groups
Percentage of patients with at least one episode of a Systolic Blood Pressure below 90mmHg (SBP < 90mmHg) in the ICU
Measured: Day 0 at discharge from ICU
Intraoperative vasopressor use between groups
Amount of IV Ephedrine (in mg) administered intraoperatively to maintain mean arterial pressure > 60 mmHg
Measured: Day 0, during surgery
Intraoperative IV Atropine use between groups
Amount of IV Atropine (in µg) administered intraoperatively to maintain a heart rage > 45bpm
Measured: Day 0, during surgery
Failure of ambulatory management between groups between groups
Percentage of patients hospitalized after surgery
Measured: Day 1
Patient reported pain between groups
Pain reported on a 0-10 visual analog scale
Measured: Day 0
Patient reported pain between groups
Pain reported on a 0-10 visual analog scale
Measured: Day 1
Patient reported pain between groups
Pain reported on a 0-10 visual analog scale
Measured: Day 2
Patient reported pain between groups
Pain reported on a 0-10 visual analog scale
Measured: Day 7
Immediate nausea and vomiting between groups
Percentage of patients with nausea and vomiting according to use of Ondansetron IV
Measured: Day 0 during ICU stay
Post-operative nausea and vomiting between groups
Percentage of patients reporting absence/presence nausea and vomiting
Measured: Day 0 at discharge from surgery
Post-operative nausea and vomiting between groups
Percentage of patients reporting absence/presence nausea and vomiting
Measured: Day 1
Post-operative nausea and vomiting between groups
Percentage of patients reporting absence/presence nausea and vomiting
Measured: Day 2
Post-operative nausea and vomiting between groups
Percentage of patients reporting absence/presence nausea and vomiting
Measured: Day 7
Patient postoperative recovery between groups
Quality of Recovery questionnaire (QoR-40) (score 0-200)
Measured: Day 2
Patient satisfaction with perioperative management between groups
Evaluation of Experience of General Anesthesia questionnaire (EVAN-G) (score 5-100)
Measured: Day 2
Occurrence of adverse events after surgery between groups
Absence/presence of the following adverse events: bleeding, hematoma or re-hospitalization
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start19 Oct 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann Gricourt, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082856
- Sponsor's protocol ID
- NIMAO/2022-1/YG01
- Acronym
- DEXCOEUR
- Status last verified
- Jun 2025
- First submitted
- 9 Oct 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery: Single-center Prospective Randomized Double-blind Non-inferiority Study.
- ClinicalTrials.gov ID
- NCT06082856
- Acronym / sponsor ID
- DEXCOEUR / NIMAO/2022-1/YG01
- Conditions
- Anesthesia, Dexmedetomidine, Hemodynamics, Ambulatory Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Oct 2023 (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.
Ambulatory surgery is increasingly used in anesthesia. In case of general anesthesia, it is recommended to use anesthesia molecules with a short half-life and low doses of opiates to ensure a rapid awakening and to prevent nausea and vomiting by systematic administration of anti-emetics during the operation.
Opiates (including sufentanil) have recently been called into question because of the nausea and vomiting and the delay in waking up induced by these molecules. To combat these side effects, the authors have proposed either to reduce the doses or to substitute them with dexmedetomidine, a sedative antihypertensive drug. Recent studies have demonstrated that opiates used in general anesthesia can be replaced by dexmedetomidine. However, literature data are controversial concerning the hemodynamic impact. No study has compared the hemodynamic profile of opioid-free anesthesia with dexmedetomidine versus conventional anesthesia with opioids.
The ambulatory context lends itself to the use of dexmedetomidine because it is aimed at a population without strong cardiac pathology, concerns non-major interventions, with the need to optimize pain and side effects.
The study authors therefore wish to compare the effects of induction of general anesthesia with low-dose Dexmedetomidine versus sufentanil, on post-induction hemodynamic stability in scheduled outpatient surgeries. The investigators hypothesize that hemodynamic stability at induction of general anesthesia with low-dose dexmedetomidine is not inferior to that obtained with sufentanil in scheduled ambulatory surgeries.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
| Sufentanil | Active comparator | Drug: Sufentanil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with scheduled surgery under general anesthesia for one of the following: oral, orthopedic, urological, digestive and gynecological surgeries.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Key exclusion criteria (12 listed)
- The subject is in a period of exclusion determined by a previous study
- The subject is unable to give consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient with a known allergy to dexmedetomidine or other drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineInduction of general anesthesia by administration of dexmedetomidine 0.5µg/Kg (maximum dose 50 µg) in titration by bolus of 10µg intravenously over 5 minutes | Drug | Dexmedetomidine |
| SufentanilInduction of general anesthesia by administration of sufentanil 0.25µg/Kg (maximum dose 20 µg) intravenously at anesthetic induction. | Drug | Sufentanil |
Primary outcome
Intraoperative hemodynamic stability during anesthesia between groups
Time frame: Within 60 minutes after induction
Incidence of mean arterial pressure < 60 mmHg
19 secondary outcomes
Intraoperative hemodynamic stability according to baseline mean arterial pressure between groups
Time frame: Within 60 minutes after induction
Intraoperative heart rate between groups
Time frame: Within 60 minutes after induction
Intraoperative hypertensive episodes between groups
Time frame: Within 60 minutes after induction
Hemodynamic stability in the ICU between groups
Time frame: Day 0 at discharge from ICU
Intraoperative vasopressor use between groups
Time frame: Day 0, during surgery
Intraoperative IV Atropine use between groups
Time frame: Day 0, during surgery
Failure of ambulatory management between groups between groups
Time frame: Day 1
Patient reported pain between groups
Time frame: Day 0
Patient reported pain between groups
Time frame: Day 1
Patient reported pain between groups
Time frame: Day 2
Patient reported pain between groups
Time frame: Day 7
Immediate nausea and vomiting between groups
Time frame: Day 0 during ICU stay
Post-operative nausea and vomiting between groups
Time frame: Day 0 at discharge from surgery
Post-operative nausea and vomiting between groups
Time frame: Day 1
Post-operative nausea and vomiting between groups
Time frame: Day 2
Post-operative nausea and vomiting between groups
Time frame: Day 7
Patient postoperative recovery between groups
Time frame: Day 2
Patient satisfaction with perioperative management between groups
Time frame: Day 2
Occurrence of adverse events after surgery between groups
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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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.
Yann Gricourt principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Sufentanil in people with Anesthesia and Dexmedetomidine, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yann Gricourt (04.66.68.30.50, yann.gricourt@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative hemodynamic stability during anesthesia between groups (time frame: Within 60 minutes after induction). 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 6 Jun 2025.