Conscious Sedation Failure During ProcedureNCT05115578
Remifentanil Effect-site Prediction by Algometry
An observational study of Conscious Sedation Failure During Procedure, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
This study validates the pharmacodynamic analgesic predictions (effect) given by Minto's remifentanil pharmacokinetic and dynamic model in conscious sedation. This standard model is based on the electroencephalogram (EEG) changes induced by this opioid as a proxy for describing the remifentanil analgesic effect, which… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation Failure During Procedure
- What is being tested?
- Remifentanil 1 MG Injection [Ultiva], Midazolam 1 MG/ML Prefilled Syringe and Saline solution
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to 30 Sep 2020
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: We enrolled 100 female patients scheduled for benign gynaecological surgery. A group of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. The second group of 35 followed the same protocol with a bolus of 1 mg of midazolam previous to the remifentanil infusion to evaluate potential anxiolysis effects. The rest configured to the control group. Algometry was used to quantify pressure pain thresholds regarding basal measurements at time-points of 1.5, 5, 10, 15, 18, 20, and 25 min after induction began beside the blood pressure and heart rate.
Who may be able to join
- Female patients scheduled for benign gynaecological surgery
- 18-80 years old
- ASA I-III
Who cannot join
- Morbid obesity
- Conduct disorder or anxiety-depressive syndrome
- Chronic treatment with psychotropic drugs or opiates
- Pregnancy
- Alcohol abuse
- Documented allergy to remifentanil or midazolam
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remifentanil Pharmacodynamics During Conscious Sedation From the Algometry Perspective. An Essential Standpoint to be Considered in Opioids Time-course Modelling Validation
This study validates the pharmacodynamic analgesic predictions (effect) given by Minto's remifentanil pharmacokinetic and dynamic model in conscious sedation. This standard model is based on the electroencephalogram (EEG) changes induced by this opioid as a proxy for describing the remifentanil analgesic effect, which might be only valid for high concentrations. Validation of the standard remifentanil model for low concentrations under sedation is needed for safer remifentanil administration.
Read the detailed description
According to pharmacokinetic and-dynamic (PK/PD) models, the proper use of anesthetics depends on the effect-sites mechanisms and the time-courses of action. This aspect is crucial for the practitioners to target the desired effect-site concentrations of the drugs (drug concentration at brain) by optimizing the drug administration using target control infusion (TCI) systems operating under these model predictions.
For more than two decades, the pharmacodynamic properties of remifentanil relied on Minto's model, which is based on processed EEG as the reference to quantify the analgesic effect and effect-site concentration estimate. This remifentanil pharmacodynamic was modeled under conditions administered to volunteers rapidly and at very high doses to induce substantial changes in the spontaneous processed EEG. The experimental concentrations and infusion rates are far from sedative levels, where the EEG has shown a clear response to hypnosis but not to analgesia or nociception.
Under the hypothesis that pharmacological models should predict equally well the effects induced by drugs at different concentrations levels, the purpose of this study is to evaluate and validate the pharmacodynamic predictions given by Minto's model in patients under conscious sedation using the algometry as a reference of nociception.
The study recruits 100 female patients scheduled for benign gynecological surgery divided into three groups. A group of 35 patients receives a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. The second group of 35 follow the same protocol with a bolus of 1 mg of midazolam before the remifentanil infusion. The rest configures the control group under saline solution.
Experimental data consist of basal algometry (pressure pain threshold) aside from BIS index, blood pressure, and heart rate values and at time-points of 1.5, 5, 10, 15, 18, 20, and 25 minutes after induction.
Minto's remifentanil pharmacodynamic model validation relies on comparing the levels and temporal evolution of the algometry measurements during the whole experiment concerning the effect-site estimations provided by the TCI-pump Minto's model.
- Being tested
- Remifentanil 1 MG Injection [Ultiva], Midazolam 1 MG/ML Prefilled Syringe, Saline solution, Algometry
- Keywords
- Remifentanil, Algometry, Pharmacodynamics, TCI Infusion system, Conscious Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil 1 MG Injection [Ultiva]Drug
Also called Opioid
Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil.
Midazolam 1 MG/ML Prefilled SyringeDrug
Also called Benzodiazepine
Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv
Saline solutionDrug
Also called 0.9% Sodium Chloride Injection
Group III Control
AlgometryDevice
Also called Somedic Type II®, Sweden
The algometry technique is used to assess the pain pressure threshold as an analgesic effect of remifentanil concerning Minto's model prediction.
| Study group | Role | What they receive |
|---|---|---|
| Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil | Group I of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. Receives: Drug: Remifentanil 1 MG Injection [Ultiva]; Device: Algometry | |
| Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv | Group II of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min with a bolus of 1 mg of midazolam previous to the remifentanil infusion Receives: Drug: Remifentanil 1 MG Injection [Ultiva]; Drug: Midazolam 1 MG/ML Prefilled Syringe; Device: Algometry | |
| Group III Control | Group III of 30 patients. The same TCI system provided the saline solution in the control group under an equivalent simulation profile to the remifentanil administration Receives: Drug: Saline solution; Device: Algometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold (PPT) Baseline
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry before starting the administration of remifentanil.
Measured: Baseline
Pressure pain threshold (PPT) 1.5 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 1.5 minutes after starting the administration of remifentanil.
Measured: 1.5 minutes
Pressure pain threshold (PPT) 5 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 5 minutes after starting the administration of remifentanil.
Measured: 5 minutes
Pressure pain threshold (PPT) 10 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 10 minutes after starting the administration of remifentanil.
Measured: 10 minutes
Pressure pain threshold (PPT) 15 minutes
Measurement of pressure pain threshold(0 - 1.000 kPa) by algometry 15 minutes after starting the administration of remifentanil.
Measured: 15 minutes
Pressure pain threshold (PPT) 18 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 18 minutes after starting the administration of remifentanil.
Measured: 18 minutes
Pressure pain threshold (PPT) 20 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 20 minutes after starting the administration of remifentanil.
Measured: 20 minutes
Pressure pain threshold (PPT) 25 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 25 minutes after starting the administration of remifentanil.
Measured: 25 minutes
Infusion rate
Remifentanil infusion rate (ml/h) administered during the experiment to the patient provided by the TCI system.
Measured: Continous measurements every 1 second for the whole experiment of 25 minutes
Remifentanil Plasma Concentration (Cp)
Patient's remifentanil plasma concentration (ng/ml) evolution during the experiment given by Minto's model implemented in the TCI system.
Measured: Continous measurements every 1 second for the whole experiment of 25 minutes
Remifentanil Effect Concentration (Ce)
Patient's remifentanil effect concentration (ng/ml) evolution during the experiment given by Minto's model implemented in the TCI system.
Measured: Continous measurements every 1 second for the whole experiment of 25 minutes
Secondary outcomes (23)
Age
Apart from standard anthropometric data (Weight, Height, etc), age is of significant relevance for evaluating the possible effect of age on the pharmacodynamic properties of remifentanil and the algometry.
Measured: Single annotation.
Mean arterial pressure (MAP) Baseline
Baseline mean arterial pressure (mmHg) from standard hemodynamic monitor.
Measured: Baseline
Mean arterial pressure (MAP) 1.5 min
Measurement of mean arterial pressure (mmHg) 1.5 minutes after starting the administration of remifentanil.
Measured: 1.5 minutes
Mean arterial pressure (MAP) 5 min
Measurement of mean arterial pressure (mmHg) 5 minutes after starting the administration of remifentanil.
Measured: 5 minutes
Mean arterial pressure (MAP) 10 min
Measurement of mean arterial pressure (mmHg) 10 minutes after starting the administration of remifentanil.
Measured: 10 minutes
Mean arterial pressure (MAP) 15 min
Measurement of mean arterial pressure (mmHg) 15 minutes after starting the administration of remifentanil.
Measured: 15 minutes
Mean arterial pressure (MAP) 18 min
Measurement of mean arterial pressure (mmHg) 18 minutes after starting the administration of remifentanil.
Measured: 18 minutes
Mean arterial pressure (MAP) 20 min
Measurement of mean arterial pressure (mmHg) 20 minutes after starting the administration of remifentanil.
Measured: 20 minutes
Mean arterial pressure (MAP) 25 min
Measurement of mean arterial pressure (mmHg) 25 minutes after starting the administration of remifentanil.
Measured: 25 minutes
Heart Rate (HR) Baseline
Baseline measurement of heart rate (beats/min)
Measured: Baseline
Heart Rate (HR) 1.5 min
Measurement of heart rate (beats/min) 1.5 minutes after starting the administration of remifentanil.
Measured: 1.5 minutes
Heart Rate (HR) 5 min
Measurement of heart rate (beats/min) 5 minutes after starting the administration of remifentanil.
Measured: 5 minutes
Heart Rate (HR) 10 min
Measurement of heart rate (beats/min) 10 minutes after starting the administration of remifentanil.
Measured: 10 minutes
Heart Rate (HR) 15 min
Measurement of heart rate (beats/min) 15 minutes after starting the administration of remifentanil.
Measured: 15 minutes
Heart Rate (HR) 18 min
Measurement of heart rate (beats/min) 18 minutes after starting the administration of remifentanil.
Measured: 18 minutes
Heart Rate (HR) 20 min
Measurement of heart rate (beats/min) 20 minutes after starting the administration of remifentanil.
Measured: 20 minutes
Bispectrum (BIS) Baseline
Baseline measurement of EEG Bispectral index (adimensional index from 0- to 100).
Measured: Baseline
Bispectrum (BIS) 1.5 minutes
EEG Bispectral index (adimensional index from 0- to 100) 1.5 minutes after starting the administration of remifentanil.
Measured: 1.5 minutes
Bispectrum (BIS) 5 minutes
EEG Bispectral index (adimensional index from 0- to 100) 5 minutes after starting the administration of remifentanil.
Measured: 5 minutes
Bispectrum (BIS) 10 minutes
EEG Bispectral index (adimensional index from 0- to 100) 10 minutes after starting the administration of remifentanil.
Measured: 10 minutes
Bispectrum (BIS) 15 minutes
EEG Bispectral index (adimensional index from 0- to 100) 15 minutes after starting the administration of remifentanil.
Measured: 15 minutes
Bispectrum (BIS) 20 minutes
EEG Bispectral index (adimensional index from 0- to 100) 20 minutes after starting the administration of remifentanil.
Measured: 20 minutes
Bispectrum (BIS) 25 minutes
EEG Bispectral index (adimensional index from 0- to 100) 25 minutes after starting the administration of remifentanil.
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Mar 2017
- Primary completion15 May 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious Sedation Failure During ProcedureStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Abad-Torrent, M.D, Principal investigator, University Vall d'Hebron Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115578
- Sponsor's protocol ID
- EPA (AG) 33/2017 (5097)
- Status last verified
- Oct 2021
- First submitted
- 15 Sep 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Pharmacodynamics During Conscious Sedation From the Algometry Perspective. An Essential Standpoint to be Considered in Opioids Time-course Modelling Validation
- ClinicalTrials.gov ID
- NCT05115578
- Acronym / sponsor ID
- EPA (AG) 33/2017 (5097)
- Keywords
- Remifentanil, Algometry, Pharmacodynamics, TCI Infusion system, Conscious Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 10 Nov 2021 (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.
This study validates the pharmacodynamic analgesic predictions (effect) given by Minto's remifentanil pharmacokinetic and dynamic model in conscious sedation. This standard model is based on the electroencephalogram (EEG) changes induced by this opioid as a proxy for describing the remifentanil analgesic effect, which might be only valid for high concentrations. Validation of the standard remifentanil model for low concentrations under sedation is needed for safer remifentanil administration.
Detailed description
According to pharmacokinetic and-dynamic (PK/PD) models, the proper use of anesthetics depends on the effect-sites mechanisms and the time-courses of action. This aspect is crucial for the practitioners to target the desired effect-site concentrations of the drugs (drug concentration at brain) by optimizing the drug administration using target control infusion (TCI) systems operating under these model predictions.
For more than two decades, the pharmacodynamic properties of remifentanil relied on Minto's model, which is based on processed EEG as the reference to quantify the analgesic effect and effect-site concentration estimate. This remifentanil pharmacodynamic was modeled under conditions administered to volunteers rapidly and at very high doses to induce substantial changes in the spontaneous processed EEG. The experimental concentrations and infusion rates are far from sedative levels, where the EEG has shown a clear response to hypnosis but not to analgesia or nociception.
Under the hypothesis that pharmacological models should predict equally well the effects induced by drugs at different concentrations levels, the purpose of this study is to evaluate and validate the pharmacodynamic predictions given by Minto's model in patients under conscious sedation using the algometry as a reference of nociception.
The study recruits 100 female patients scheduled for benign gynecological surgery divided into three groups. A group of 35 patients receives a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. The second group of 35 follow the same protocol with a bolus of 1 mg of midazolam before the remifentanil infusion. The rest configures the control group under saline solution.
Experimental data consist of basal algometry (pressure pain threshold) aside from BIS index, blood pressure, and heart rate values and at time-points of 1.5, 5, 10, 15, 18, 20, and 25 minutes after induction.
Minto's remifentanil pharmacodynamic model validation relies on comparing the levels and temporal evolution of the algometry measurements during the whole experiment concerning the effect-site estimations provided by the TCI-pump Minto's model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil | – | Drug: Remifentanil 1 MG Injection [Ultiva], Device: AlgometryGroup I of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. |
| Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv | – | Drug: Remifentanil 1 MG Injection [Ultiva], Drug: Midazolam 1 MG/ML Prefilled Syringe, Device: AlgometryGroup II of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min with a bolus of 1 mg of midazolam previous to the remifentanil infusion |
| Group III Control | – | Drug: Saline solution, Device: AlgometryGroup III of 30 patients. The same TCI system provided the saline solution in the control group under an equivalent simulation profile to the remifentanil administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We enrolled 100 female patients scheduled for benign gynaecological surgery. A group of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. The second group of 35 followed the same protocol with a bolus of 1 mg of midazolam previous to the remifentanil infusion to evaluate potential anxiolysis effects. The rest configured to the control group. Algometry was used to quantify pressure pain thresholds regarding basal measurements at time-points of 1.5, 5, 10, 15, 18, 20, and 25 min after induction began beside the blood pressure and heart rate.
Key inclusion criteria (3 listed)
- Female patients scheduled for benign gynaecological surgery
- 18-80 years old
- ASA I-III
Key exclusion criteria (7 listed)
- Morbid obesity
- Conduct disorder or anxiety-depressive syndrome
- Chronic treatment with psychotropic drugs or opiates
- Pregnancy
- Alcohol abuse
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 |
|---|---|---|
| Remifentanil 1 MG Injection [Ultiva]Also: OpioidGroup I TCI effect-site target infusion of 1.5 ng/ml of remifentanil. | Drug | Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil, Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv |
| Midazolam 1 MG/ML Prefilled SyringeAlso: BenzodiazepineGroup II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv | Drug | Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv |
| Saline solutionAlso: 0.9% Sodium Chloride InjectionGroup III Control | Drug | Group III Control |
| AlgometryAlso: Somedic Type II®, SwedenThe algometry technique is used to assess the pain pressure threshold as an analgesic effect of remifentanil concerning Minto's model prediction. | Device | Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil, Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv, Group III Control |
Primary outcome
Pressure pain threshold (PPT) Baseline
Time frame: Baseline
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry before starting the administration of remifentanil.
Pressure pain threshold (PPT) 1.5 minutes
Time frame: 1.5 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 1.5 minutes after starting the administration of remifentanil.
Pressure pain threshold (PPT) 5 minutes
Time frame: 5 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 5 minutes after starting the administration of remifentanil.
Pressure pain threshold (PPT) 10 minutes
Time frame: 10 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 10 minutes after starting the administration of remifentanil.
Pressure pain threshold (PPT) 15 minutes
Time frame: 15 minutes
Measurement of pressure pain threshold(0 - 1.000 kPa) by algometry 15 minutes after starting the administration of remifentanil.
Pressure pain threshold (PPT) 18 minutes
Time frame: 18 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 18 minutes after starting the administration of remifentanil.
Pressure pain threshold (PPT) 20 minutes
Time frame: 20 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 20 minutes after starting the administration of remifentanil.
Pressure pain threshold (PPT) 25 minutes
Time frame: 25 minutes
Measurement of pressure pain threshold (0 - 1.000 kPa) by algometry 25 minutes after starting the administration of remifentanil.
Infusion rate
Time frame: Continous measurements every 1 second for the whole experiment of 25 minutes
Remifentanil infusion rate (ml/h) administered during the experiment to the patient provided by the TCI system.
Remifentanil Plasma Concentration (Cp)
Time frame: Continous measurements every 1 second for the whole experiment of 25 minutes
Patient's remifentanil plasma concentration (ng/ml) evolution during the experiment given by Minto's model implemented in the TCI system.
Remifentanil Effect Concentration (Ce)
Time frame: Continous measurements every 1 second for the whole experiment of 25 minutes
Patient's remifentanil effect concentration (ng/ml) evolution during the experiment given by Minto's model implemented in the TCI system.
23 secondary outcomes
Age
Time frame: Single annotation.
Mean arterial pressure (MAP) Baseline
Time frame: Baseline
Mean arterial pressure (MAP) 1.5 min
Time frame: 1.5 minutes
Mean arterial pressure (MAP) 5 min
Time frame: 5 minutes
Mean arterial pressure (MAP) 10 min
Time frame: 10 minutes
Mean arterial pressure (MAP) 15 min
Time frame: 15 minutes
Mean arterial pressure (MAP) 18 min
Time frame: 18 minutes
Mean arterial pressure (MAP) 20 min
Time frame: 20 minutes
Mean arterial pressure (MAP) 25 min
Time frame: 25 minutes
Heart Rate (HR) Baseline
Time frame: Baseline
Heart Rate (HR) 1.5 min
Time frame: 1.5 minutes
Heart Rate (HR) 5 min
Time frame: 5 minutes
Heart Rate (HR) 10 min
Time frame: 10 minutes
Heart Rate (HR) 15 min
Time frame: 15 minutes
Heart Rate (HR) 18 min
Time frame: 18 minutes
Heart Rate (HR) 20 min
Time frame: 20 minutes
Bispectrum (BIS) Baseline
Time frame: Baseline
Bispectrum (BIS) 1.5 minutes
Time frame: 1.5 minutes
Bispectrum (BIS) 5 minutes
Time frame: 5 minutes
Bispectrum (BIS) 10 minutes
Time frame: 10 minutes
Bispectrum (BIS) 15 minutes
Time frame: 15 minutes
Bispectrum (BIS) 20 minutes
Time frame: 20 minutes
Bispectrum (BIS) 25 minutes
Time frame: 25 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ana Abad-Torrent, M.D principal investigator
University Vall d'Hebron Hospital
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 Conscious Sedation Failure During Procedure, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 7 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: finished, as of the sponsor's last update on 10 Nov 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (PPT) Baseline (time frame: Baseline). The study lists 11 primary outcomes in all. 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 10 Nov 2021; AzTrials last refreshed its copy on 30 Oct 2026.