Haemodynamic Fluctuations During Off-pump CABG.NCT01871935
Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil
A study testing Remifentanil and Sufentanil in people with Haemodynamic Fluctuations During Off-pump CABG., run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodynamic Fluctuations During Off-pump CABG.
- What is being tested?
- Remifentanil and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- 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
- Age: 18 years and older.
- Elective CABG surgery performed off-pump.
- Written informed consent to participate in this study.
- Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.
Who cannot join
- Refusal to participate in this study.
- Age: younger than 18 years.
- Pregnant.
- BMI > 35 kg/m2.
- Patients in which atropine is contra-indicated.
- Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.
- Urgent or emergency surgery.
Trial locations and contacts
1 site in 1 country.
Alain F Kalmar, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ
Rob Spanjersberg, r.spanjersberg@umcg.nl
Alain F Kalmar, MD, PhD
About this study
Official title: Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil
Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on the determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators have demonstrated a significant and clinically relevant increase in CO and cerebral tissue oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more usual clinical practice of administrating classical vasoactive medication such as phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and SctO2. In previous research the investigators used standardized target controlled propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known that remifentanil has more intense haemodynamic side-effects compared to other opiates such as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid during anaesthesia of propofol combined with other opiates such as sufentanil.
Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep general anaesthesia, which is usually performed with the combination of drugs as mentioned above. Because these patients often experience severe haemodynamic fluctuations they need to be closely monitored.
- Being tested
- Remifentanil, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Anaesthesia with remifentanil/propofol.
SufentanilDrug
Anaesthesia with sufentanil/propofol
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | Anaesthesia with remifentanil/propofol Receives: Drug: Remifentanil |
| Sufentanil | Active comparator | Anaesthesia with sufentanil/propofol Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
CO
Measured: During anaesthesia
Secondary outcomes (3)
MAP
Measured: During anaesthesia
Tissue oxygen saturation
Measured: During anaesthesia
CO
CO obtained by different devices/methods (i.e. the Vigileo device and TEE)
Measured: During anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionJun 2014 (estimated)
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 Haemodynamic Fluctuations During Off-pump CABG.Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.F.Kalmar, University Medical Center Groningen
- Investigators
- Alain F Kalmar, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871935
- Sponsor's protocol ID
- SuRe-002
- Status last verified
- Jan 2014
- First submitted
- 30 May 2013
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Poterman M, Kalmar AF, Buisman PL, Struys MMRF, Scheeren TWL. Improved haemodynamic stability and cerebral tissue oxygenation after induction of anaesthesia with sufentanil compared to remifentanil: a randomised controlled trial. BMC Anesthesiol. 2020 Oct 7;20(1):258. doi: 10.1186/s12871-020-01174-9.
PubMed 33028197
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil
- ClinicalTrials.gov ID
- NCT01871935
- Acronym / sponsor ID
- SuRe-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 7 Jun 2013 (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.
Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on the determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators have demonstrated a significant and clinically relevant increase in CO and cerebral tissue oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more usual clinical practice of administrating classical vasoactive medication such as phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and SctO2. In previous research the investigators used standardized target controlled propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known that remifentanil has more intense haemodynamic side-effects compared to other opiates such as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid during anaesthesia of propofol combined with other opiates such as sufentanil.
Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep general anaesthesia, which is usually performed with the combination of drugs as mentioned above. Because these patients often experience severe haemodynamic fluctuations they need to be closely monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: RemifentanilAnaesthesia with remifentanil/propofol |
| Sufentanil | Active comparator | Drug: SufentanilAnaesthesia with sufentanil/propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years and older.
- Elective CABG surgery performed off-pump.
- Written informed consent to participate in this study.
- Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.
Key exclusion criteria (7 listed)
- Refusal to participate in this study.
- Age: younger than 18 years.
- Pregnant.
- BMI > 35 kg/m2.
- Patients in which atropine is contra-indicated.
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 |
|---|---|---|
| RemifentanilAnaesthesia with remifentanil/propofol. | Drug | Remifentanil |
| SufentanilAnaesthesia with sufentanil/propofol | Drug | Sufentanil |
Primary outcome
CO
Time frame: During anaesthesia
3 secondary outcomes
MAP
Time frame: During anaesthesia
Tissue oxygen saturation
Time frame: During anaesthesia
CO
Time frame: During anaesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Derived from this study: PubMed 33028197Poterman M, Kalmar AF, Buisman PL, Struys MMRF, Scheeren TWL. Improved haemodynamic stability and cerebral tissue oxygenation after induction of anaesthesia with sufentanil compared to remifentanil: a randomised controlled trial. BMC Anesthesiol. 2020 Oct 7;20(1):258. doi: 10.1186/s12871-020-01174-9.
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.
Alain F Kalmar, MD, PhD contact
Alain F Kalmar, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil and Sufentanil in people with Haemodynamic Fluctuations During Off-pump CABG., run by University Medical Center Groningen at 1 site in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2014. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain F Kalmar, MD, PhD (a.f.kalmar@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CO (time frame: During anaesthesia). 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 NCT01871935, 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 31 Jan 2014.