Intravenous Anesthetic Agent OverdosePhase 4NCT02884310
Interest of a Tetanus Test at a Fixed Remifentanil Concentration Before Laryngoscopy and Skin Incision
A Phase 4 study testing Remifentanil adapted to SPI and Remifentanil fixed in people with Intravenous Anesthetic Agent Overdose, run by Erasme University Hospital.
Trial summary
Individually-tailored administration of the opioid analgesic component during general anaesthesia is still a challenge for the anesthesiologist. The aim of this protocol is to look if the gradient response of a nociception index to a calibrated tetanic stimulus during standard anesthetic conditions, could help to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intravenous Anesthetic Agent Overdose
- What is being tested?
- Remifentanil adapted to SPI and Remifentanil fixed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to May 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Informed consent obtained during the pre-anesthetic visit
- American Society Anesthesiology status I or II
- Scheduled surgery under general anesthesia, and necessitating endotracheal intubation and controlled mechanical ventilation
- Body mass index (BMI) between 17 and 30 kg/m2
Who cannot join
- Pregnancy
- Patient refusal
- Pace maker (all modes)
- Heart failure
- Ejection fraction < 50%
- Symptomatic aortic or mitral pathology
Show all 12Show fewer
- Non sinus rhythm
- Chronic use of beta blocking agents or other anti-hypertensive medications, except for diuretics
- Dysautonomia
- Diabetes
- Spontaneous ventilation during anesthesia
- Allergy to one of the medications used during this experiment
About this study
Official title: Interest of the Gradient of Nociceptive Indexes After a Tetanus (100 Hz, 60 Milliamperes, 30 Seconds) at a Fixed Remifentanil Effect Site Concentration to Adjust Remifentanil Before Tracheal Intubation and Skin Incision
Individually-tailored administration of the opioid analgesic component during general anaesthesia is still a challenge for the anesthesiologist. The aim of this protocol is to look if the gradient response of a nociception index to a calibrated tetanic stimulus during standard anesthetic conditions, could help to titrate remifentanil analgesia before tracheal intubation and before skin incision. The studied parameters are the SPI index developed by General Electric, the "Analgesia Nociception Index" and the pupil dilation using the pupil scan algometer.
Read the detailed description
Two randomized groups of patients scheduled for general surgery under Target Controlled remifentanil propofol anaesthesia are compared.
All patients receive two standard calibration tests (Tetanic stimulus at the ulnar nerve: 100 Hertz, 60 milliamperes, 30 seconds) before tracheal intubation and skin incision at a stable remifentanil level of 3 ng/ml. Propofol concentration is targeted to maintain the BIS value as close as possible to 50. Patients are mechanically ventilated at an inspired O2 concentration of 50% and using tidal volumes of 8 to 10 mL/kg and respiratory rates of 12 to 15/min. Patients receive an induction dose of neuromuscular blocking agent.
In the treated group, the importance of the Surgical Plethysmogram Index (SPI) gradient after the tetanic stimulus will guide the subsequent administration of remifentanil to cover tracheal intubation and surgical incision. As compared to SPI value before the calibration test, a less than 10 unit increase in SPI will not prompt any change in remifentanil concentration before tracheal intubation and surgical incision. An increase in SPI between 10 and 20 units will prompt a remifentanil effect-site target concentration of 4 ng/ml, between 20 and 30 of 5 ng/ml, and above 30 of 6 ng/ml for tracheal intubation. Once the trachea is intubated, remifentanil concentration will be lowered to 3 ng /ml. It will be adjusted again before surgical incision according to the same criteria. Ten minutes after surgical incision until the end of the surgical procedure, the remifentanil concentration will be targeted to maintain SPI between 20 and 50.
In the control group, conditions will be the same as those of first group, except that remifentanil concentration will be adjusted according to heart rate and blood pressure. The anesthesiologist in charge is blinded to the results of the SPI gradient after the two calibration tests at 3 ng/ml remifentanil concentration and also blinded to the 2 other nociception indexes at all times. Remifentanil concentration is targeted at 4 ng/ml before tracheal intubation and surgical incision. Ten minutes after skin incision until the end of surgery, remifentanil concentrations will be adjusted according to the hemodynamic parameters.
Data acquisition and analysis will lead to the following statistical comparisons between the two groups:
- Hemodynamic reactivity to tracheal intubation and surgical incision.
- Concordance between SPI, Analgesia Nociception Index (ANI), and pupil diameter variations in response to the calibration test and during maintenance of anesthesia.
- Reliability of the prediction of hemodynamic reactivity to intubation and incision by the SPI, ANI, pupil diameter and hemodynamic response to the calibration test, and improvement of the prediction when combining the information given by those parameters.
2.2. Monitoring The monitoring will correspond to the classical monitoring of any general anesthesia procedures (Electrocardiogram, peripheral saturation in O2, Non-Invasive Blood Pressure, respiratory gases, pressure and flows in the airway, muscle relaxation).
The following parameters will be continuously recorded and saved for subsequent analysis :
- Heart rate
- Inspired and expired gases : O2, Carbon dioxide (CO2)
- Spirometry : peak, plateau, and end-expiratory pressures
- EKG : heart rate
- Non-invasive blood pressure : automatic measured every 5 minutes
- SPI
Additional monitoring :
- Bispectral Index (BIS)
- ANI
- Pupil dilation measurement
2.3. Anesthetic medications
2.3.1. Premedication The premedication will consist of 0.5 mg oral alprazolam (XANAX) one hour before induction of anesthesia.
2.3.2. Anesthesia General anesthesia will be induced and maintained using Target Controlled Infusions (TCI) of propofol and remifentanil, and using a single cisatracurium bolus.
2.3.2.1. Induction of anesthesia In the experimental group, the initial target effect-site concentration (Ce) of remifentanil will be 3 ng/ml and 3 µg/ml for propofol. The propofol Ce will be increased by steps of 1 µg/ml until loss of consciousness (6.0 µg/ml maximum). A 0.2 mg/kg bolus of cisatracurium will be given immediately after loss of consciousness. The tetanic calibration test will be performed once all responses to train of four (TOF) stimulation have disappeared. The BIS target before the tetanic stimulation will be 50 (range 40-60).
Pupil dilation and the ANI response to the tetanic stimulation will also be measured.
After tracheal intubation, remifentanil concentration will be reduced to 3 ng/ml, and propofol concentration adjusted to keep the BIS value as close to 50 as possible.
In the control group, the induction of anesthesia will occur the same way as in the experimental group, except that the initial concentration of remifentanil will be 3 ng/ml, and 4 ng/ml for tracheal intubation and incision. It will be changed according to hemodynamic parameters thereafter. Propofol concentration will be targeted to maintain stable BIS values around 50. The tetanic calibration test will be performed blindly once all responses to TOF stimulation have disappeared, and once propofol and remifentanil concentrations have been stable for more than 5 minutes. SPI, ANI, and pupil diameter values will be blindly recorded.
2.3.2.2. Maintenance of anesthesia The upper and lower limits of propofol concentrations will be 2.0 and 6.0 µg/ml, respectively. It will be targeted to maintain a stable BIS value around 50. During surgery, remifentanil concentrations will range between 2.0 and 10 ng/ml. In the experimental group (SPI), the calibration test-defined remifentanil concentration and the pre-incision propofol concentration will be kept intact for 10 minutes after the surgical incision. Thereafter, they will be modified according to the below-defined criteria.
In the control group, remifentanil concentration will be maintained at 4 ng/ml during 10 minutes after the surgical incision. Thereafter, propofol and remifentanil concentrations will be modified according to hemodynamic reactivity, and according to BIS, which will be kept at 50 (see tables below). SPI, and the other nociception indexes will be blindly recorded in that group.
2.3.2.3. Propofol concentration adaptations in both groups Propofol concentrations will be adapted to maintain BIS as close to 50 as possible. Changes in propofol concentration will be allowed every 5 minutes after having reached the new target, if necessary, as a function of criteria defined in Table 2.
Table 2 Propofol concentration adaptation as a function of BIS BIS Change in propofol concentration >70 +2 µg/ml > 55 +1 µg/ml < 45 -0.5 µg/ml < 35 -1 µg/ml
2.3.2.4. Remifentanil concentration adaptations
2.3.2.4.1. In the experimental group The goal in the experimental group will be to maintain a SPI value between 20 and 40 during surgery, from 10 minutes after incision to the end.
After incision, remifentanil concentration will be adapted according to criteria defined in Table 3.
Table 3 Remifentanil concentration adaptation during surgery (range 2 to 10 ng/ml) Event Change in remifentanil concentration SPI<20 -1 ng/ml SPI>50 +1 ng/ml SPI>80 +2 ng/ml
In case of hemodynamic reactivity (increase or decrease of more than 20 % as compared to reference values), despite adequate adaptation of remifentanil concentration as a function of SPI, it will be corrected according to criteria defined in paragraph 2.5 for hypotension or bradycardia episodes. In case of hypertension, (more than 20% as compared to reference value), despite adequate remifentanil concentration adaptation as a function of SPI, 0.5 mg intravenous boluses of nicardipine (Nicardipine) will be administered intravenously until return to acceptable values. Similarly, in case of tachycardia despite adequate adaptation of remifentanil adaptation as a function of SPI values, it will be corrected by 1 mg intravenous boluses of metoprolol (Seloken) until return to pre-defined values. In the event of both cases, exclusion of the patient's data from statistical analysis should be considered.
2.3.2.4.2. In the control group Before surgical incision, in the absence of hemodynamic reactivity, remifentanil concentration will be 4 ng/ml, and will not change for 10 minutes after incision.
Ten minutes after incision, remifentanil concentration will be adapted according to hemodynamic reactivity
Table 4 Remifentanil concentration adaptation in the Control group Hemodynamic Reactivity (> 20% as compared to reference values or Mean Arterial Pressure (MAP) > 90 mmHg and/or Heart Rate (HR) > 100/min): -1 ng/ml Hypotension/bradycardia (<20% as compared to reference values or MAP < 60 mmHg and/or HR < 45/min): +1 ng/ml
Remifentanil concentration will always be kept between 2 and 10 ng/ml. In case of hemodynamic changes at those concentrations, they will be corrected according to the criteria defined above for the SPI group.
- Conditions
- Intravenous Anesthetic Agent Overdose
- Being tested
- Remifentanil adapted to SPI, Remifentanil fixed
- Keywords
- Remifentanil, Heart Rate Variability, Pupil dilation, SPI
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil adapted to SPIDrug
Remifentanil fixedDrug
| Study group | Role | What they receive |
|---|---|---|
| SPI group | Experimental | Remifentanil titration before tracheal intubation and skin incision according to the SPI gradient obtained after a nociceptive test using a tetanic stimulus of 100 Hz, 60 milliamperes during 30 seconds performed at a 3 ng/ml level of the remifentanil concentration.
During surgery, the effect site remifentanil concentration was either increased or decreased by 1 ng/ml to maintain SPI below 40 or above 20, respectively. Receives: Drug: Remifentanil adapted to SPI |
| Control group | Active comparator | The remifentanil concentration before tracheal intubation and skin incision was fixed at 4 ng/ml.
During surgery, the remifentanil concentration was adapted according to the hemodynamic answer of the patient. It was changed by 1 ng/ml stepwise variations to maintain heart rate and mean blood pressure within 20% of the patient reference hemodynamic values. Receives: Drug: Remifentanil fixed |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic stability following tracheal intubation and surgical incision
Improvement of hemodynamic stability at anesthesia induction if remifentanil analgesia is not fixed at a predefined value for all patients but adapted to a nociceptive test at a predefined remifentanil concentration
Measured: within 60 minutes after anesthesia induction
Secondary outcomes (1)
hemodynamic stability during surgery
Improvement of hemodynamic stability during surgery if remifentanil is adapted to SPI changes
Measured: within surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous Anesthetic Agent OverdoseStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege
- Responsible party
- Principal investigator, Luc Barvais, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884310
- Sponsor's protocol ID
- ErasmeUH P2012/20
- Status last verified
- Aug 2017
- First submitted
- 18 Aug 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Defresne A, Barvais L, Clement F, Bonhomme V. Standardised noxious stimulation-guided individual adjustment of remifentanil target-controlled infusion to prevent haemodynamic responses to laryngoscopy and surgical incision: A randomised controlled trial. Eur J Anaesthesiol. 2018 Mar;35(3):173-183. doi: 10.1097/EJA.0000000000000742.
PubMed 29189318
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Gradient of Nociceptive Indexes After a Tetanus (100 Hz, 60 Milliamperes, 30 Seconds) at a Fixed Remifentanil Effect Site Concentration to Adjust Remifentanil Before Tracheal Intubation and Skin Incision
- ClinicalTrials.gov ID
- NCT02884310
- Acronym / sponsor ID
- ErasmeUH P2012/20
- Conditions
- Intravenous Anesthetic Agent Overdose
- Keywords
- Remifentanil, Heart Rate Variability, Pupil dilation, SPI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- University of Liege
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 31 Aug 2016 (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.
Individually-tailored administration of the opioid analgesic component during general anaesthesia is still a challenge for the anesthesiologist. The aim of this protocol is to look if the gradient response of a nociception index to a calibrated tetanic stimulus during standard anesthetic conditions, could help to titrate remifentanil analgesia before tracheal intubation and before skin incision. The studied parameters are the SPI index developed by General Electric, the "Analgesia Nociception Index" and the pupil dilation using the pupil scan algometer.
Detailed description
Two randomized groups of patients scheduled for general surgery under Target Controlled remifentanil propofol anaesthesia are compared.
All patients receive two standard calibration tests (Tetanic stimulus at the ulnar nerve: 100 Hertz, 60 milliamperes, 30 seconds) before tracheal intubation and skin incision at a stable remifentanil level of 3 ng/ml. Propofol concentration is targeted to maintain the BIS value as close as possible to 50. Patients are mechanically ventilated at an inspired O2 concentration of 50% and using tidal volumes of 8 to 10 mL/kg and respiratory rates of 12 to 15/min. Patients receive an induction dose of neuromuscular blocking agent.
In the treated group, the importance of the Surgical Plethysmogram Index (SPI) gradient after the tetanic stimulus will guide the subsequent administration of remifentanil to cover tracheal intubation and surgical incision. As compared to SPI value before the calibration test, a less than 10 unit increase in SPI will not prompt any change in remifentanil concentration before tracheal intubation and surgical incision. An increase in SPI between 10 and 20 units will prompt a remifentanil effect-site target concentration of 4 ng/ml, between 20 and 30 of 5 ng/ml, and above 30 of 6 ng/ml for tracheal intubation. Once the trachea is intubated, remifentanil concentration will be lowered to 3 ng /ml. It will be adjusted again before surgical incision according to the same criteria. Ten minutes after surgical incision until the end of the surgical procedure, the remifentanil concentration will be targeted to maintain SPI between 20 and 50.
In the control group, conditions will be the same as those of first group, except that remifentanil concentration will be adjusted according to heart rate and blood pressure. The anesthesiologist in charge is blinded to the results of the SPI gradient after the two calibration tests at 3 ng/ml remifentanil concentration and also blinded to the 2 other nociception indexes at all times. Remifentanil concentration is targeted at 4 ng/ml before tracheal intubation and surgical incision. Ten minutes after skin incision until the end of surgery, remifentanil concentrations will be adjusted according to the hemodynamic parameters.
Data acquisition and analysis will lead to the following statistical comparisons between the two groups:
- Hemodynamic reactivity to tracheal intubation and surgical incision.
- Concordance between SPI, Analgesia Nociception Index (ANI), and pupil diameter variations in response to the calibration test and during maintenance of anesthesia.
- Reliability of the prediction of hemodynamic reactivity to intubation and incision by the SPI, ANI, pupil diameter and hemodynamic response to the calibration test, and improvement of the prediction when combining the information given by those parameters.
2.2. Monitoring The monitoring will correspond to the classical monitoring of any general anesthesia procedures (Electrocardiogram, peripheral saturation in O2, Non-Invasive Blood Pressure, respiratory gases, pressure and flows in the airway, muscle relaxation).
The following parameters will be continuously recorded and saved for subsequent analysis :
- Heart rate
- Inspired and expired gases : O2, Carbon dioxide (CO2)
- Spirometry : peak, plateau, and end-expiratory pressures
- EKG : heart rate
- Non-invasive blood pressure : automatic measured every 5 minutes
- SPI
Additional monitoring :
- Bispectral Index (BIS)
- ANI
- Pupil dilation measurement
2.3. Anesthetic medications
2.3.1. Premedication The premedication will consist of 0.5 mg oral alprazolam (XANAX) one hour before induction of anesthesia.
2.3.2. Anesthesia General anesthesia will be induced and maintained using Target Controlled Infusions (TCI) of propofol and remifentanil, and using a single cisatracurium bolus.
2.3.2.1. Induction of anesthesia In the experimental group, the initial target effect-site concentration (Ce) of remifentanil will be 3 ng/ml and 3 µg/ml for propofol. The propofol Ce will be increased by steps of 1 µg/ml until loss of consciousness (6.0 µg/ml maximum). A 0.2 mg/kg bolus of cisatracurium will be given immediately after loss of consciousness. The tetanic calibration test will be performed once all responses to train of four (TOF) stimulation have disappeared. The BIS target before the tetanic stimulation will be 50 (range 40-60).
Pupil dilation and the ANI response to the tetanic stimulation will also be measured.
After tracheal intubation, remifentanil concentration will be reduced to 3 ng/ml, and propofol concentration adjusted to keep the BIS value as close to 50 as possible.
In the control group, the induction of anesthesia will occur the same way as in the experimental group, except that the initial concentration of remifentanil will be 3 ng/ml, and 4 ng/ml for tracheal intubation and incision. It will be changed according to hemodynamic parameters thereafter. Propofol concentration will be targeted to maintain stable BIS values around 50. The tetanic calibration test will be performed blindly once all responses to TOF stimulation have disappeared, and once propofol and remifentanil concentrations have been stable for more than 5 minutes. SPI, ANI, and pupil diameter values will be blindly recorded.
2.3.2.2. Maintenance of anesthesia The upper and lower limits of propofol concentrations will be 2.0 and 6.0 µg/ml, respectively. It will be targeted to maintain a stable BIS value around 50. During surgery, remifentanil concentrations will range between 2.0 and 10 ng/ml. In the experimental group (SPI), the calibration test-defined remifentanil concentration and the pre-incision propofol concentration will be kept intact for 10 minutes after the surgical incision. Thereafter, they will be modified according to the below-defined criteria.
In the control group, remifentanil concentration will be maintained at 4 ng/ml during 10 minutes after the surgical incision. Thereafter, propofol and remifentanil concentrations will be modified according to hemodynamic reactivity, and according to BIS, which will be kept at 50 (see tables below). SPI, and the other nociception indexes will be blindly recorded in that group.
2.3.2.3. Propofol concentration adaptations in both groups Propofol concentrations will be adapted to maintain BIS as close to 50 as possible. Changes in propofol concentration will be allowed every 5 minutes after having reached the new target, if necessary, as a function of criteria defined in Table 2.
Table 2 Propofol concentration adaptation as a function of BIS BIS Change in propofol concentration >70 +2 µg/ml > 55 +1 µg/ml < 45 -0.5 µg/ml < 35 -1 µg/ml
2.3.2.4. Remifentanil concentration adaptations
2.3.2.4.1. In the experimental group The goal in the experimental group will be to maintain a SPI value between 20 and 40 during surgery, from 10 minutes after incision to the end.
After incision, remifentanil concentration will be adapted according to criteria defined in Table 3.
Table 3 Remifentanil concentration adaptation during surgery (range 2 to 10 ng/ml) Event Change in remifentanil concentration SPI<20 -1 ng/ml SPI>50 +1 ng/ml SPI>80 +2 ng/ml
In case of hemodynamic reactivity (increase or decrease of more than 20 % as compared to reference values), despite adequate adaptation of remifentanil concentration as a function of SPI, it will be corrected according to criteria defined in paragraph 2.5 for hypotension or bradycardia episodes. In case of hypertension, (more than 20% as compared to reference value), despite adequate remifentanil concentration adaptation as a function of SPI, 0.5 mg intravenous boluses of nicardipine (Nicardipine) will be administered intravenously until return to acceptable values. Similarly, in case of tachycardia despite adequate adaptation of remifentanil adaptation as a function of SPI values, it will be corrected by 1 mg intravenous boluses of metoprolol (Seloken) until return to pre-defined values. In the event of both cases, exclusion of the patient's data from statistical analysis should be considered.
2.3.2.4.2. In the control group Before surgical incision, in the absence of hemodynamic reactivity, remifentanil concentration will be 4 ng/ml, and will not change for 10 minutes after incision.
Ten minutes after incision, remifentanil concentration will be adapted according to hemodynamic reactivity
Table 4 Remifentanil concentration adaptation in the Control group Hemodynamic Reactivity (> 20% as compared to reference values or Mean Arterial Pressure (MAP) > 90 mmHg and/or Heart Rate (HR) > 100/min): -1 ng/ml Hypotension/bradycardia (<20% as compared to reference values or MAP < 60 mmHg and/or HR < 45/min): +1 ng/ml
Remifentanil concentration will always be kept between 2 and 10 ng/ml. In case of hemodynamic changes at those concentrations, they will be corrected according to the criteria defined above for the SPI group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI group | Experimental | Drug: Remifentanil adapted to SPIRemifentanil titration before tracheal intubation and skin incision according to the SPI gradient obtained after a nociceptive test using a tetanic stimulus of 100 Hz, 60 milliamperes during 30 seconds performed at a 3 ng/ml level of the remifentanil concentration. During surgery, the effect site remifentanil concentration was either increased or decreased by 1 ng/ml to maintain SPI below 40 or above 20, respectively. |
| Control group | Active comparator | Drug: Remifentanil fixedThe remifentanil concentration before tracheal intubation and skin incision was fixed at 4 ng/ml. During surgery, the remifentanil concentration was adapted according to the hemodynamic answer of the patient. It was changed by 1 ng/ml stepwise variations to maintain heart rate and mean blood pressure within 20% of the patient reference hemodynamic values. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >= 18 years
- Informed consent obtained during the pre-anesthetic visit
- American Society Anesthesiology status I or II
- Scheduled surgery under general anesthesia, and necessitating endotracheal intubation and controlled mechanical ventilation
- Body mass index (BMI) between 17 and 30 kg/m2
Key exclusion criteria (12 listed)
- Pregnancy
- Patient refusal
- Pace maker (all modes)
- Heart failure
- Non sinus rhythm
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 adapted to SPI | Drug | SPI group |
| Remifentanil fixed | Drug | Control group |
Primary outcome
hemodynamic stability following tracheal intubation and surgical incision
Time frame: within 60 minutes after anesthesia induction
Improvement of hemodynamic stability at anesthesia induction if remifentanil analgesia is not fixed at a predefined value for all patients but adapted to a nociceptive test at a predefined remifentanil concentration
1 secondary outcome
hemodynamic stability during surgery
Time frame: within surgery
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 22 Aug 2017.
- Derived from this study: PubMed 29189318Defresne A, Barvais L, Clement F, Bonhomme V. Standardised noxious stimulation-guided individual adjustment of remifentanil target-controlled infusion to prevent haemodynamic responses to laryngoscopy and surgical incision: A randomised controlled trial. Eur J Anaesthesiol. 2018 Mar;35(3):173-183. doi: 10.1097/EJA.0000000000000742.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil adapted to SPI and Remifentanil fixed in people with Intravenous Anesthetic Agent Overdose, run by Erasme University Hospital.
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 5 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: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
hemodynamic stability following tracheal intubation and surgical incision (time frame: within 60 minutes after anesthesia induction). 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 NCT02884310, which also lists 1 linked publication.
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 22 Aug 2017.