Drug InteractionsPhase 4SPRVNCT02457442
Interaction of Sevoflurane Propofol and Remifentanil in Anesthesia for Laparoscopic Surgery
A Phase 4 study testing Propofol and Remifentanil, Sevoflurane and Remifentanil and SPR 1 in people with Drug Interactions and Anesthesia, Conduction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Recently a new model for the interaction of sevoflurane propofol and remifentanil was developed. The potency of any combination of the three drugs is defined as probability that a subject tolerates laryngoscopy without movement response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Interactions, Anesthesia, Conduction
- What is being tested?
- Propofol and Remifentanil, Sevoflurane and Remifentanil and SPR 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2015to 23 Oct 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status 1 or 2
- Written informed consent
Who cannot join
- Cardiovascular disease
- Pulmonary disease
- Liver disease
- CNS disease
- Alcohol or drug abuse
- Chronic intake of CNS active drugs
Show all 9Show fewer
- Body mass index > 35
- Diabetes mellitus
- Hypersensitivity or allergy to one of the study drugs
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesiology and Pain Therapy, Bern University Hospital
Bern, 3010
About this study
Official title: Validation of the Interaction Model of the Anesthetic Potency of Sevoflurane, Propofol and Remifentanil
Recently a new model for the interaction of sevoflurane propofol and remifentanil was developed. The potency of any combination of the three drugs is defined as probability that a subject tolerates laryngoscopy without movement response. The model allows to compare the potency of intravenous and inhalation anesthetics. If the model is valid also for other stimuli than laryngoscopy and for other responses (e.g. blood pressure or heart rate increase upon stimulation). If the model is valid equipotent concentrations of sevoflurane and propofol the same remifentanil concentration would be sufficient to suppress hemodynamic response to a given stimulus. This will be investigated it the study.
Read the detailed description
Background
In general anesthesia propofol or volatile anesthetic are usually combined with opioids and the synergy between hypnotics and opioids is used to reduce the dose of each component in order to minimize side effects and to allow a rapid recovery. Current pharmacodynamic interaction models allow to estimate the potency of combinations of propofol and opioids, volatile anesthetics and opioids or propofol and sevoflurane respectively. In these interaction models the potency of the drug combinations is expressed as probability that motor response to laryngoscopy is suppressed (= tolerance of laryngoscopy, PTOL). The potency of the hypnotic drugs is represented by the concentration preventing motor response to laryngoscopy in 50% of the population (Ce50 hypnotic). Conversely potency of the opioids is represented as concentration reducing the Ce50 of the hypnotics by 50%.
The data of the three previous studies on propofol-remifentanil, propofol-sevoflurane and sevoflurane-remifentanil interaction were pooled and reanalyzed. The result was a triple interaction model of sevoflurane, propofol and remifentanil where sevoflurane and propofol were additive and either propofol or sevoflurane were synergistic with remifentanil. In contrast to the previous studies the response surface of the propofol-remifentanil and sevoflurane-remifentanil derived from the pooled re-analysis had a similar shape, which is reflected by a common C50 remifentanil and a common slope parameter. This means that remifentanil is equally synergistic to propofol and sevoflurane. The next step is to validate this interaction model with other stimuli than laryngoscopy and with other responses to stimulation that movement.
In clinical practice not motor response but hemodynamic response (heart rate and arterial blood pressure increase) upon surgical stimulation is used to titrate anesthetics and opioids.
In laparoscopic surgery after a small skin incision, carbon dioxide is inflated into the abdominal cavity to maintain an intraabdominal pressure of 14 mmHg. Recently the sevoflurane concentration preventing a heart rate or blood pressure increase greater than 20% upon installation of pneumoperitoneum (MAC BAR pneumoperitoneum) has been determined: The MAC BAR pneumoperitoneum (95% CI) of sevoflurane was 4.6 (4.3-4.9) without opioids and 2.4 (2.2-2.6) and 1.7 (1.4-2.1) vol% with an effect site remifentanil concentration of 1 and 2 ng ml-1.These values all correspond to 90% probability to tolerate laryngoscopy (PTOL) according to our triple interaction model (Hannivoort, BJA 2016), which indirectly supports our model.
The main purpose of this randomized controlled study is to validate our sevoflurane-propofol-remifentanil interaction model using skin incision and carbon dioxide insufflation (pneumoperitoneum) as stimulus and blood pressure and heart rate response as endpoint.
Objective
To determine the C50 remifentanil preventing a 20% increase of heart rate or mean arterial pressure upon installation of pneumoperitoneum at equipotent concentrations of sevoflurane or propofol To determine the C50 of sevoflurane and propofol preventing a 20% increase of heart rate or mean arterial pressure upon installation of pneumoperitoneum at a standardized concentration of remifentanil
To determine the C50 of propofol or sevoflurane preventing a 20% increase of heart rate or mean arterial pressure upon installation of pneumoperitoneum at standardized concentrations of remifentanil plus sevoflurane or propofol respectively.
Methods
Patients will be randomly assigned to six groups with different propofol sevoflurane and remifentanil target concentrations for skin incision: Two groups with be given propofol-remifentanil, sevoflurane-remifentanil and sevoflurane-propofol-remifentanil respectively. The up-and-down method will be applied to determine the C50ies. During surgery primarily remifentanil and secondarily sevoflurane or propofol are titrated to maintain mean arterial pressure and bispectral index within predefined limits.
- Conditions
- Drug Interactions, Anesthesia, Conduction
- Being tested
- Propofol and Remifentanil, Sevoflurane and Remifentanil, SPR 1, SPR2
- Keywords
- Anesthetics, Inhalation, Anesthetics, Intravenous, Analgesics, Opioid
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol and RemifentanilDrug
High propofol and low remifentanil, changing remifentanil (up-and-down method)
Propofol and RemifentanilDrug
Low propofol and high remifentanil, changing propofol (up-and-down method)
Sevoflurane and RemifentanilDrug
High sevoflurane and low remifentanil, changing remifentanil (up-and-down method)
Sevoflurane and RemifentanilDrug
Low sevoflurane and high remifentanil, changing sevoflurane up-and-down method)
SPR 1Drug
Triple combination with intermediate propofol and sevoflurane and intermediate remifentanil.
SPR 1: Changing Propofol for skin incision.
SPR2Drug
Triple combination with intermediate propofol and sevoflurane and intermediate remifentanil.
Changing Sevoflurane for skin incision.
| Study group | Role | What they receive |
|---|---|---|
| PR1 | Active comparator | (Arm closed in May 2022) Propofol-Remifentanil: Prop high, Remi low. Changing Remi (up-and-down) Receives: Drug: Propofol and Remifentanil |
| PR2 | Active comparator | (Arm closed in May 2022) Propofol-Remifentanil: Prop low, Remi high. Changing Prop (up-and-down) Receives: Drug: Propofol and Remifentanil |
| SR1 | Active comparator | (Arm closed in May 2022) Sevoflurane-Remifentanil: Sevo high, Remi low. Changing Remi (up-and-down) Receives: Drug: Sevoflurane and Remifentanil |
| SR2 | Active comparator | (Arm closed in May 2022) Sevoflurane-Remifentanil: Sevo low, Remi high. Changing Sevo (up-and-down) Receives: Drug: Sevoflurane and Remifentanil |
| SPR1 | Active comparator | (Arm closed in October 2023) Sevoflurane-Propofol-Remifentanil: Sevo plus Remi intermediate, Remi intermediate; changing Propofol. Receives: Drug: SPR 1 |
| SPR2 | Active comparator | (Arm closed in October 2023) Sevoflurane-Propofol-Remifentanil: Sevo plus Remi intermediate, Remi intermediate; changing Sevoflurane. Receives: Drug: SPR2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
20% heart rate or mean arterial pressure increase upon installation of pneumoperitoneum
Measured: 5 Minutes upon establishment of intraabdominal working pressure (12 mmHg)
Secondary outcomes (4)
Mean (SD) Bloodpressure during surgery
Measured: Values recorded on computer HD every 10 sec during anesthesia, expected to be on average ca. 60 - 240 minutes
Mean (SD) Bispectral Index during surgery
Measured: Values recorded on computer HD every 10 sec. during anesthesia, expected to be on average ca. 60 - 240 minutes
Mean (SD) Remifentanil concentration during surgery
Measured: During surgery, expected to be on average ca. 60 - 240 minutes
Postoperative quality of recovery score
Measured: During hospital stay, expected to be on average ca. 3-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startDec 2015
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Luginbühl, PD Dr. med., Study chair, Spital Tiefenau, Inselgruppe, Abteilung für Anästhesie und Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457442
- Sponsor's protocol ID
- SPRV
- Other IDs
- 157/15
- Acronym
- SPRV
- Status last verified
- Nov 2023
- First submitted
- 26 May 2015
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schumacher PM, Dossche J, Mortier EP, Luginbuehl M, Bouillon TW, Struys MM. Response surface modeling of the interaction between propofol and sevoflurane. Anesthesiology. 2009 Oct;111(4):790-804. doi: 10.1097/ALN.0b013e3181b799ef.
PubMed 19741484Heyse B, Proost JH, Schumacher PM, Bouillon TW, Vereecke HE, Eleveld DJ, Luginbuhl M, Struys MM. Sevoflurane remifentanil interaction: comparison of different response surface models. Anesthesiology. 2012 Feb;116(2):311-23. doi: 10.1097/ALN.0b013e318242a2ec.
PubMed 22222473Luginbuhl M, Schumacher PM, Vuilleumier P, Vereecke H, Heyse B, Bouillon TW, Struys MM. Noxious stimulation response index: a novel anesthetic state index based on hypnotic-opioid interaction. Anesthesiology. 2010 Apr;112(4):872-80. doi: 10.1097/ALN.0b013e3181d40368.
PubMed 20216387Bouillon TW, Bruhn J, Radulescu L, Andresen C, Shafer TJ, Cohane C, Shafer SL. Pharmacodynamic interaction between propofol and remifentanil regarding hypnosis, tolerance of laryngoscopy, bispectral index, and electroencephalographic approximate entropy. Anesthesiology. 2004 Jun;100(6):1353-72. doi: 10.1097/00000542-200406000-00006.
PubMed 15166553Hannivoort LN, Vereecke HE, Proost JH, Heyse BE, Eleveld DJ, Bouillon TW, Struys MM, Luginbuhl M. Probability to tolerate laryngoscopy and noxious stimulation response index as general indicators of the anaesthetic potency of sevoflurane, propofol, and remifentanil. Br J Anaesth. 2016 May;116(5):624-31. doi: 10.1093/bja/aew060.
PubMed 27106965
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Interaction Model of the Anesthetic Potency of Sevoflurane, Propofol and Remifentanil
- ClinicalTrials.gov ID
- NCT02457442
- Acronym / sponsor ID
- SPRV / SPRV
- Conditions
- Drug Interactions, Anesthesia, Conduction
- Keywords
- Anesthetics, Inhalation, Anesthetics, Intravenous, Analgesics, Opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 29 May 2015 (estimated)
- 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.
Recently a new model for the interaction of sevoflurane propofol and remifentanil was developed. The potency of any combination of the three drugs is defined as probability that a subject tolerates laryngoscopy without movement response. The model allows to compare the potency of intravenous and inhalation anesthetics. If the model is valid also for other stimuli than laryngoscopy and for other responses (e.g. blood pressure or heart rate increase upon stimulation). If the model is valid equipotent concentrations of sevoflurane and propofol the same remifentanil concentration would be sufficient to suppress hemodynamic response to a given stimulus. This will be investigated it the study.
Detailed description
Background
In general anesthesia propofol or volatile anesthetic are usually combined with opioids and the synergy between hypnotics and opioids is used to reduce the dose of each component in order to minimize side effects and to allow a rapid recovery. Current pharmacodynamic interaction models allow to estimate the potency of combinations of propofol and opioids, volatile anesthetics and opioids or propofol and sevoflurane respectively. In these interaction models the potency of the drug combinations is expressed as probability that motor response to laryngoscopy is suppressed (= tolerance of laryngoscopy, PTOL). The potency of the hypnotic drugs is represented by the concentration preventing motor response to laryngoscopy in 50% of the population (Ce50 hypnotic). Conversely potency of the opioids is represented as concentration reducing the Ce50 of the hypnotics by 50%.
The data of the three previous studies on propofol-remifentanil, propofol-sevoflurane and sevoflurane-remifentanil interaction were pooled and reanalyzed. The result was a triple interaction model of sevoflurane, propofol and remifentanil where sevoflurane and propofol were additive and either propofol or sevoflurane were synergistic with remifentanil. In contrast to the previous studies the response surface of the propofol-remifentanil and sevoflurane-remifentanil derived from the pooled re-analysis had a similar shape, which is reflected by a common C50 remifentanil and a common slope parameter. This means that remifentanil is equally synergistic to propofol and sevoflurane. The next step is to validate this interaction model with other stimuli than laryngoscopy and with other responses to stimulation that movement.
In clinical practice not motor response but hemodynamic response (heart rate and arterial blood pressure increase) upon surgical stimulation is used to titrate anesthetics and opioids.
In laparoscopic surgery after a small skin incision, carbon dioxide is inflated into the abdominal cavity to maintain an intraabdominal pressure of 14 mmHg. Recently the sevoflurane concentration preventing a heart rate or blood pressure increase greater than 20% upon installation of pneumoperitoneum (MAC BAR pneumoperitoneum) has been determined: The MAC BAR pneumoperitoneum (95% CI) of sevoflurane was 4.6 (4.3-4.9) without opioids and 2.4 (2.2-2.6) and 1.7 (1.4-2.1) vol% with an effect site remifentanil concentration of 1 and 2 ng ml-1.These values all correspond to 90% probability to tolerate laryngoscopy (PTOL) according to our triple interaction model (Hannivoort, BJA 2016), which indirectly supports our model.
The main purpose of this randomized controlled study is to validate our sevoflurane-propofol-remifentanil interaction model using skin incision and carbon dioxide insufflation (pneumoperitoneum) as stimulus and blood pressure and heart rate response as endpoint.
Objective
To determine the C50 remifentanil preventing a 20% increase of heart rate or mean arterial pressure upon installation of pneumoperitoneum at equipotent concentrations of sevoflurane or propofol To determine the C50 of sevoflurane and propofol preventing a 20% increase of heart rate or mean arterial pressure upon installation of pneumoperitoneum at a standardized concentration of remifentanil
To determine the C50 of propofol or sevoflurane preventing a 20% increase of heart rate or mean arterial pressure upon installation of pneumoperitoneum at standardized concentrations of remifentanil plus sevoflurane or propofol respectively.
Methods
Patients will be randomly assigned to six groups with different propofol sevoflurane and remifentanil target concentrations for skin incision: Two groups with be given propofol-remifentanil, sevoflurane-remifentanil and sevoflurane-propofol-remifentanil respectively. The up-and-down method will be applied to determine the C50ies. During surgery primarily remifentanil and secondarily sevoflurane or propofol are titrated to maintain mean arterial pressure and bispectral index within predefined limits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PR1 | Active comparator | Drug: Propofol and Remifentanil(Arm closed in May 2022) Propofol-Remifentanil: Prop high, Remi low. Changing Remi (up-and-down) |
| PR2 | Active comparator | Drug: Propofol and Remifentanil(Arm closed in May 2022) Propofol-Remifentanil: Prop low, Remi high. Changing Prop (up-and-down) |
| SR1 | Active comparator | Drug: Sevoflurane and Remifentanil(Arm closed in May 2022) Sevoflurane-Remifentanil: Sevo high, Remi low. Changing Remi (up-and-down) |
| SR2 | Active comparator | Drug: Sevoflurane and Remifentanil(Arm closed in May 2022) Sevoflurane-Remifentanil: Sevo low, Remi high. Changing Sevo (up-and-down) |
| SPR1 | Active comparator | Drug: SPR 1(Arm closed in October 2023) Sevoflurane-Propofol-Remifentanil: Sevo plus Remi intermediate, Remi intermediate; changing Propofol. |
| SPR2 | Active comparator | Drug: SPR2(Arm closed in October 2023) Sevoflurane-Propofol-Remifentanil: Sevo plus Remi intermediate, Remi intermediate; changing Sevoflurane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status 1 or 2
- Written informed consent
Key exclusion criteria (9 listed)
- Cardiovascular disease
- Pulmonary disease
- Liver disease
- CNS disease
- Alcohol or drug 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 |
|---|---|---|
| Propofol and RemifentanilHigh propofol and low remifentanil, changing remifentanil (up-and-down method) | Drug | PR1 |
| Propofol and RemifentanilLow propofol and high remifentanil, changing propofol (up-and-down method) | Drug | PR2 |
| Sevoflurane and RemifentanilHigh sevoflurane and low remifentanil, changing remifentanil (up-and-down method) | Drug | SR1 |
| Sevoflurane and RemifentanilLow sevoflurane and high remifentanil, changing sevoflurane up-and-down method) | Drug | SR2 |
| SPR 1Triple combination with intermediate propofol and sevoflurane and intermediate remifentanil. SPR 1: Changing Propofol for skin incision. | Drug | SPR1 |
| SPR2Triple combination with intermediate propofol and sevoflurane and intermediate remifentanil. Changing Sevoflurane for skin incision. | Drug | SPR2 |
Primary outcome
20% heart rate or mean arterial pressure increase upon installation of pneumoperitoneum
Time frame: 5 Minutes upon establishment of intraabdominal working pressure (12 mmHg)
4 secondary outcomes
Mean (SD) Bloodpressure during surgery
Time frame: Values recorded on computer HD every 10 sec during anesthesia, expected to be on average ca. 60 - 240 minutes
Mean (SD) Bispectral Index during surgery
Time frame: Values recorded on computer HD every 10 sec. during anesthesia, expected to be on average ca. 60 - 240 minutes
Mean (SD) Remifentanil concentration during surgery
Time frame: During surgery, expected to be on average ca. 60 - 240 minutes
Postoperative quality of recovery score
Time frame: During hospital stay, expected to be on average ca. 3-5 days
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 29 Nov 2023.
- Background: PubMed 19741484Schumacher PM, Dossche J, Mortier EP, Luginbuehl M, Bouillon TW, Struys MM. Response surface modeling of the interaction between propofol and sevoflurane. Anesthesiology. 2009 Oct;111(4):790-804. doi: 10.1097/ALN.0b013e3181b799ef.
- Background: PubMed 22222473Heyse B, Proost JH, Schumacher PM, Bouillon TW, Vereecke HE, Eleveld DJ, Luginbuhl M, Struys MM. Sevoflurane remifentanil interaction: comparison of different response surface models. Anesthesiology. 2012 Feb;116(2):311-23. doi: 10.1097/ALN.0b013e318242a2ec.
- Background: PubMed 20216387Luginbuhl M, Schumacher PM, Vuilleumier P, Vereecke H, Heyse B, Bouillon TW, Struys MM. Noxious stimulation response index: a novel anesthetic state index based on hypnotic-opioid interaction. Anesthesiology. 2010 Apr;112(4):872-80. doi: 10.1097/ALN.0b013e3181d40368.
- Background: PubMed 15166553Bouillon TW, Bruhn J, Radulescu L, Andresen C, Shafer TJ, Cohane C, Shafer SL. Pharmacodynamic interaction between propofol and remifentanil regarding hypnosis, tolerance of laryngoscopy, bispectral index, and electroencephalographic approximate entropy. Anesthesiology. 2004 Jun;100(6):1353-72. doi: 10.1097/00000542-200406000-00006.
- Background: PubMed 27106965Hannivoort LN, Vereecke HE, Proost JH, Heyse BE, Eleveld DJ, Bouillon TW, Struys MM, Luginbuhl M. Probability to tolerate laryngoscopy and noxious stimulation response index as general indicators of the anaesthetic potency of sevoflurane, propofol, and remifentanil. Br J Anaesth. 2016 May;116(5):624-31. doi: 10.1093/bja/aew060.
Related trials for Drug Interactions
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
RecruitingObservational study
Molecular Basis of Human Phagocyte Interactions With Bacterial Pathogens
Host Defense Mechanisms
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingPhase 1
A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
Healthy
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.
Martin Luginbühl, PD Dr. med. study chair
Spital Tiefenau, Inselgruppe, Abteilung für Anästhesie und Intensivmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Remifentanil, Sevoflurane and Remifentanil and SPR 1 in people with Drug Interactions and Anesthesia, Conduction, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 9 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 29 Nov 2023. 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 Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
20% heart rate or mean arterial pressure increase upon installation of pneumoperitoneum (time frame: 5 Minutes upon establishment of intraabdominal working pressure (12 mmHg)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457442, which also lists 5 linked publications.
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 Nov 2023.