Vaginal HysterectomyPhase 3NCT03883347
Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia
A Phase 3 study testing Dexmedetomidine and Remifentanil in people with Vaginal Hysterectomy and Suburethral Slings, run by University of Athens at 1 site in Greece.
Trial summary
Neuraxial blocks are usually used as an anaesthetic method for urogynecological surgeries. In most patients under regional anaesthesia, premedication is given for reducing anxiety. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Vaginal Hysterectomy, Suburethral Slings
- What is being tested?
- Dexmedetomidine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 20 Mar 2019to 20 Apr 2022
- Phase
- Phase 3
- 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status according to American Society of Anesthesiologists (ASA) I-II
- Patients scheduled for transvaginal urogynecological or gynecological surgery
Who cannot join
- Patient refusal
- Contraindication of spinal anaesthesia (Coagulopathy, Local infection at the site of injection, Local anaesthetic allergy, Hypovolaemia)
- BMI > 30 kg/m2
- Personal history of cardiovascular disease
- Arrythmias
- Conduction disorders
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- Severe kidney or liver dysfunction
- Insulin-dependent diabetes mellitus
- Central nervous system disorders
- Psychiatric and mental status disorders
- Chronic Excessive Alcohol Consumption
- Chronic Use of Opioid Analgesics
- Chronic Use of corticosteroids
- Chronic Use of clonidine (or other a2 adrenergic agonist)
- Use of drugs acting on central nervous system or analgetics the last two weeks
- Communication problems due to language barriers or unable to understand the pain scale
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Aretaieio Hospital, University of Athens
Athens, Attica, 11528
Chryssoula V Staikou, MD, +210 7286172, c_staikou@yahoo.gr
Chryssoula V Staikou, MD, DESA
About this study
Official title: Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia : Impact on Block Characteristics, on Acute and Chronic Postoperative Pain
Neuraxial blocks are usually used as an anaesthetic method for urogynecological surgeries. In most patients under regional anaesthesia, premedication is given for reducing anxiety. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of dexmedetomidine vs remifentanil for sedation in patients under spinal anaesthesia for urogynecological procedures.
Read the detailed description
The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include ECG, noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). A peripheral intravenous catheter wil be placed for fluid replacement ( Ringer's Lactate solution 6 - 8ml/ kg/hr) and administration of drugs.
Women will be randomly assigned into one of two groups:
Group A: Women will receive dexmedetomidine continuously infused at a dose of 0,6 mcg/kg for 10 minutes (concentration of the solution 6mcg/ml) before spinal anaesthesia. Infusion will be stopped in order to proceed with regional anesthesia.
Group B: Women will receive remifentanil continuously infused at a dose of 1mcg/kg for 10 minutes (concentration of the solution 1mcg/ml) before spinal anaesthesia. Infusion will be stopped in order to proceed with regional anesthesia.
The insertion of a 27 Gauge (27G) spinal needle is performed at L3-L4 or L4-L5 interspace, in the lateral position. All patients will receive 2,7 ml ropivacaine 0,75% and 15 mcg fentanyl intrathecally and assessment of sensory and motor block will be assessed every 2 min. The moment that sensory block is in the highest dermatome and motor block is complete (Bromage grade 3) is Time to max effect (Tmax). In group A an infusion of dexmedetomidine (6mcg/ml) at a dose of 0,6mcg/kg/hr will be administered and in group B an infusion of remifentanil (1mcg/ml) at a dose of 0,03 mcg/kg/min.At the end of the surgery patients will be transferred in Post Anaesthetic Care Unit (PACU) and a patient control analgesia (PCA) pump will be provided to the patient, administering 1 mg of morphine in every attempt, with a lock out interval of 10 minutes.There will be no continuous infusion. All patients will receive a standardized multimodal approach, including diclofenac 50 mg t.i.d, paracetamol 1gr as rescue analgesia (max 4 gr per day) and PCA with morphine.
- Conditions
- Vaginal Hysterectomy, Suburethral Slings
- Being tested
- Dexmedetomidine, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEXDOR
Intravenous administration of dexmedetomidine 0.6 mcg / kg within 10 minutes prior to regional anesthesia and 0.6 mcg / kg / h after performing regional anaesthesia until the end of the surgery
RemifentanilDrug
Also called ULTIVA
Intravenous administration of remifentanil 1 mcg / kg within 10 minutes prior to regional anesthesia and 0.025 mcg / kg / h after performing regional anaesthesia until the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Group DEX | Active comparator | Intravenous administration of dexmedetomidine 0.6 mcg / kg within 10 minutes prior to regional anesthesia. The infusion of the solution will be discontinued and then will be performed in all patients subarachnoid anesthesia. Starting with Tmax, infusion of the solution will be initiated again at a dose of 0.6 mcg / kg / h. Receives: Drug: Dexmedetomidine |
| Group REMI | Active comparator | Intravenous administration of remifentanil 1 mcg / kg within 10 minutes prior to regional anesthesia. The infusion of the solution will be discontinued and then will be performed in all patients subarachnoid anesthesia. Starting with Tmax, infusion of the solution will be initiated again at a dose of 0.025 mcg / kg / min. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative analgesia
Time for first analgesia / PCA first bolus
Measured: 24 hours postoperatively
Secondary outcomes (1)
Analgesic consumption
Morphine consumption in mg
Measured: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start20 Mar 2019
- Primary completion20 Mar 2022 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HysterectomyStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staikou Chryssoula, University of Athens
- Investigators
- Cryssoula Staikou, Principal investigator, Aretaieio Hospital Medical School University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883347
- Sponsor's protocol ID
- 107/13-02-2019
- Status last verified
- Oct 2019
- First submitted
- 18 Mar 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation With Dexmedetomidine Versus Remifentanil in Urogynecological Surgery Under Spinal Anaesthesia : Impact on Block Characteristics, on Acute and Chronic Postoperative Pain
- ClinicalTrials.gov ID
- NCT03883347
- Acronym / sponsor ID
- 107/13-02-2019
- Conditions
- Vaginal Hysterectomy, Suburethral Slings
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 20 Mar 2019 (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.
Neuraxial blocks are usually used as an anaesthetic method for urogynecological surgeries. In most patients under regional anaesthesia, premedication is given for reducing anxiety. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of dexmedetomidine vs remifentanil for sedation in patients under spinal anaesthesia for urogynecological procedures.
Detailed description
The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include ECG, noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). A peripheral intravenous catheter wil be placed for fluid replacement ( Ringer's Lactate solution 6 - 8ml/ kg/hr) and administration of drugs.
Women will be randomly assigned into one of two groups:
Group A: Women will receive dexmedetomidine continuously infused at a dose of 0,6 mcg/kg for 10 minutes (concentration of the solution 6mcg/ml) before spinal anaesthesia. Infusion will be stopped in order to proceed with regional anesthesia.
Group B: Women will receive remifentanil continuously infused at a dose of 1mcg/kg for 10 minutes (concentration of the solution 1mcg/ml) before spinal anaesthesia. Infusion will be stopped in order to proceed with regional anesthesia.
The insertion of a 27 Gauge (27G) spinal needle is performed at L3-L4 or L4-L5 interspace, in the lateral position. All patients will receive 2,7 ml ropivacaine 0,75% and 15 mcg fentanyl intrathecally and assessment of sensory and motor block will be assessed every 2 min. The moment that sensory block is in the highest dermatome and motor block is complete (Bromage grade 3) is Time to max effect (Tmax). In group A an infusion of dexmedetomidine (6mcg/ml) at a dose of 0,6mcg/kg/hr will be administered and in group B an infusion of remifentanil (1mcg/ml) at a dose of 0,03 mcg/kg/min.At the end of the surgery patients will be transferred in Post Anaesthetic Care Unit (PACU) and a patient control analgesia (PCA) pump will be provided to the patient, administering 1 mg of morphine in every attempt, with a lock out interval of 10 minutes.There will be no continuous infusion. All patients will receive a standardized multimodal approach, including diclofenac 50 mg t.i.d, paracetamol 1gr as rescue analgesia (max 4 gr per day) and PCA with morphine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DEX | Active comparator | Drug: DexmedetomidineIntravenous administration of dexmedetomidine 0.6 mcg / kg within 10 minutes prior to regional anesthesia. The infusion of the solution will be discontinued and then will be performed in all patients subarachnoid anesthesia. Starting with Tmax, infusion of the solution will be initiated again at a dose of 0.6 mcg / kg / h. |
| Group REMI | Active comparator | Drug: RemifentanilIntravenous administration of remifentanil 1 mcg / kg within 10 minutes prior to regional anesthesia. The infusion of the solution will be discontinued and then will be performed in all patients subarachnoid anesthesia. Starting with Tmax, infusion of the solution will be initiated again at a dose of 0.025 mcg / kg / min. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physical status according to American Society of Anesthesiologists (ASA) I-II
- Patients scheduled for transvaginal urogynecological or gynecological surgery
Key exclusion criteria (16 listed)
- Patient refusal
- Contraindication of spinal anaesthesia (Coagulopathy, Local infection at the site of injection, Local anaesthetic allergy, Hypovolaemia)
- BMI > 30 kg/m2
- Personal history of cardiovascular disease
- Arrythmias
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 |
|---|---|---|
| DexmedetomidineAlso: DEXDORIntravenous administration of dexmedetomidine 0.6 mcg / kg within 10 minutes prior to regional anesthesia and 0.6 mcg / kg / h after performing regional anaesthesia until the end of the surgery | Drug | Group DEX |
| RemifentanilAlso: ULTIVAIntravenous administration of remifentanil 1 mcg / kg within 10 minutes prior to regional anesthesia and 0.025 mcg / kg / h after performing regional anaesthesia until the end of the surgery | Drug | Group REMI |
Primary outcome
Duration of postoperative analgesia
Time frame: 24 hours postoperatively
Time for first analgesia / PCA first bolus
1 secondary outcome
Analgesic consumption
Time frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Cryssoula Staikou principal investigator
Aretaieio Hospital Medical School University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Remifentanil in people with Vaginal Hysterectomy and Suburethral Slings, run by University of Athens at 1 site in Greece.
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 2 inclusion and 16 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 14 Oct 2019. 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 Greece. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Panagiota Brattou (+306957786459, brattoup@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative analgesia (time frame: 24 hours postoperatively). 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 14 Oct 2019.