AnesthesiaNCT02046590
RCT of Efficacy and Safety of Sedation Compared to General Anesthesia for ERCP
A study testing Propofol and General anesthesia in people with Anesthesia and ERCP, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
There is a worldwide trend to minimally invasive interventions, which results in increasing numbers of interventions performed outside of the operating room. Currently, approximately 12 to 15% of total anaesthetic workload is non-operating room anaesthesia (NORA) and this anaesthetic activity is increasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, ERCP, Safety
- What is being tested?
- Propofol and General anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to 13 Feb 2023
- 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
- Patient with scheduled therapeutic ERCP
- Written informed consent for the study protocol obtained from the patient or his/her legal representative
- Anaesthetist available for the procedure
Who cannot join
- Mechanically ventilated patients before the procedure
- Baseline oxyhemoglobin saturation < 90%
- Baseline systolic blood pressure < 90 mm Hg
- American Society of Anaesthesiologists (ASA) physical score 5 (Table 1)
- Age < 18 years
- Pregnancy
Show all 15Show fewer
- Emergency procedure
- Absence of fasting ≥ 6 hours for solids and ≥ 2 hours for clear liquids
- Contraindication to any study drug
- Short, thick neck or trismus that may complicate airway rescue
- Previous documented difficult airway intubation
- Obstructive sleep apnea
- Severe swallowing disorders with documented broncho-aspiration
- Bowel obstruction
- Inclusion in the present protocol during the 30 preceding days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial (RCT) of Efficacy and Safety of Sedation Compared to General Anesthesia for Endoscopic Retrograde Cholangio-pancreatography
There is a worldwide trend to minimally invasive interventions, which results in increasing numbers of interventions performed outside of the operating room. Currently, approximately 12 to 15% of total anaesthetic workload is non-operating room anaesthesia (NORA) and this anaesthetic activity is increasing.
Many of these interventions need supplementary comfort measures to have relaxed patients and high success rates. Endoscopic retrograde cholangio-pancreatography (ERCP) is performed >50,000 times per year in the U.S.,and is a typical minimally invasive intervention that needs patient sedation.
Read more
There is a controversy about the optimal comfort intervention in minimally invasive interventions and in particular in ERCP. Two different approaches to insure patients' comfort have been proposed: general anaesthesia with endotracheal intubation and mechanical ventilation or sedation with spontaneous ventilation.
Well-performed studies on sedation versus general anaesthesia using a randomized controlled trial design with observer blinding will contribute to improve the decision-making for the optimal comfort measures in minimally invasive procedures. At our knowledge such a randomized controlled trial has not been reported before. The investigators hypothesize that deep sedation without tracheal intubation will achieve similar success rates for ERCP as general anaesthesia and will have similar rates of harmful postoperative effects.
The primary aim of this trial is to demonstrate that the success rate of ERCP is not inferior in patients randomized to deep sedation without orotracheal intubation vs general anesthesia with orotracheal intubation. Secondary aims include a comparison between randomization groups of patient safety, patient and endoscopist satisfaction, duration of patient recovery and of anesthesia procedure.
Read the detailed description
What may be the benefits of general anaesthesia? In one retrospective study of more than 1000 patients, the ERCP failure rate with general anaesthesia was half compared to that observed with moderate sedation (7% versus 14%), with most failures resulting from inadequate sedation. It has also been reported that complication rates associated with therapeutic interventions during ERCP may be significantly lower when general anaesthesia is used, perhaps because the absence of patient movement makes the procedure technically less difficult. When general anaesthesia is administered for ERCP, the airway is protected by endotracheal intubation which may decrease risk for broncho-aspiration in some patients, although this measure has not been demonstrated to be effective in patients at risk during digestive endoscopy.
However, aspiration at the time of in/ex-tubation as well as micro-aspiration of contaminated upper airway secretions along leaks and defects of the tracheal cuff seal is not excluded if standard endotracheal tubes are used.
What may be the harms of general anaesthesia? Intubation and extubation manoeuvres may prolong endoscopic room occupation time, post-anaesthesia care unit stay may be longer and about 30 to 70% of patients will suffer from sore throat (this is reduced if lidocaine is used).
Furthermore, orotracheal intubation may induce short time hemodynamic changes related to laryngoscopy.
What may be the benefits of deep sedation? The main advantage of sedation is probably the faster turnover in the intervention room. In the sole practice survey of anesthesiologists for endoscopy that is available, 81% of anaesthesiologists stated that they were using sedation, not general anesthesia, for ERCP.
Deep sedation with propofol during digestive endoscopy has been shown to be superior to moderate sedation with a combination of benzodiazepine plus opioid in many aspects, including better patient cooperation, shorter recovery time and lower number of desaturation events.
In Switzerland, sedation during ERCP is obtained using benzodiazepines or propofol in similar proportions of cases and, when propofol is used, it is administered by the endoscopist or nurse in two thirds of cases and by the anaesthesiologist in one third of cases.
Evidence from prospective studies suggests that complex procedures, including therapeutic ERCP, may be performed safely under deep sedation without tracheal intubation using propofol, even in high-risk patients.
What may be harms of deep sedation? In a large study including nearly 10'000 patients, adverse events were observed in 1.4% of patients sedated using propofol. In that study, adverse events were defined as premature termination of the procedure due to sedation-related events (most often related to hypoxemia) or the need for assisted ventilation or, very rarely, admission to intensive care unit.
- Conditions
- Anesthesia, ERCP, Safety, Efficacy
- Being tested
- Propofol, General anesthesia
- Keywords
- Propofol, remifentanil, safety, gastro-intestinal, ERCP, minimally invasive, intubation, ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
General anesthesiaOther
| Study group | Role | What they receive |
|---|---|---|
| Deep Sedation | Active comparator | Remifentanil 1ng/ml throughout the procedure. Propofol administration starts at an initial (estimated plasma) target concentration of 1,5 microg/ml.
Propofol administration is adjusted to level 1 or 2 on the modified observer's assessment of alertness/sedation scale. The propofol infusion will be increased stepwise by 0,5 microg/ml every 1 minute until loss of consciousness. Propofol is continued while maintaining spontaneous ventilation without assistance and systolic blood pressure ≥ 60 % of baseline systolic blood pressure. Receives: Drug: Propofol |
| General Anaesthesia | Active comparator | General anesthesia will be induced with target controlled infusion (TCI) of propofol and remifentanil as in the group "deep sedation".
Suxamethonium (succinylcholine) will be used to facilitate intubation. Endotracheal tube balloon pressure will be controlled during the procedure. Ventilation will be assisted using 40% oxygen in air mixture and mechanically controlled using an anaesthetic ventilator. Receives: Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERCP success rate
The primary study outcome will be a comparison between patient allocation groups and the percentage of completely successful ERCP. Success of ERCP is defined as achieving both high completion and low adverse event rate.
Measured: 24 hours
Secondary outcomes (1)
Success of ERCP in subgroups of patients
Secondary outcome will include a comparison between patient allocation groups of the success of ERCP in subgroups of patients (difficulty grade of ERCP = 2 or 3, ASA score = 4)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Why it stopped: Recruitment too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, vincent huberty, Erasme University Hospital
- Investigators
- Vincent Huberty, MD, Principal investigator, Gastroenterology Department Erasme Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046590
- Sponsor's protocol ID
- B406201318623
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2014
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) of Efficacy and Safety of Sedation Compared to General Anesthesia for Endoscopic Retrograde Cholangio-pancreatography
- ClinicalTrials.gov ID
- NCT02046590
- Acronym / sponsor ID
- B406201318623
- Conditions
- Anesthesia, ERCP, Safety, Efficacy
- Keywords
- Propofol, remifentanil, safety, gastro-intestinal, ERCP, minimally invasive, intubation, ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment too slow
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 28 Jan 2014 (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.
There is a worldwide trend to minimally invasive interventions, which results in increasing numbers of interventions performed outside of the operating room. Currently, approximately 12 to 15% of total anaesthetic workload is non-operating room anaesthesia (NORA) and this anaesthetic activity is increasing.
Many of these interventions need supplementary comfort measures to have relaxed patients and high success rates. Endoscopic retrograde cholangio-pancreatography (ERCP) is performed >50,000 times per year in the U.S.,and is a typical minimally invasive intervention that needs patient sedation.
There is a controversy about the optimal comfort intervention in minimally invasive interventions and in particular in ERCP. Two different approaches to insure patients' comfort have been proposed: general anaesthesia with endotracheal intubation and mechanical ventilation or sedation with spontaneous ventilation.
Well-performed studies on sedation versus general anaesthesia using a randomized controlled trial design with observer blinding will contribute to improve the decision-making for the optimal comfort measures in minimally invasive procedures. At our knowledge such a randomized controlled trial has not been reported before. The investigators hypothesize that deep sedation without tracheal intubation will achieve similar success rates for ERCP as general anaesthesia and will have similar rates of harmful postoperative effects.
The primary aim of this trial is to demonstrate that the success rate of ERCP is not inferior in patients randomized to deep sedation without orotracheal intubation vs general anesthesia with orotracheal intubation. Secondary aims include a comparison between randomization groups of patient safety, patient and endoscopist satisfaction, duration of patient recovery and of anesthesia procedure.
Detailed description
What may be the benefits of general anaesthesia? In one retrospective study of more than 1000 patients, the ERCP failure rate with general anaesthesia was half compared to that observed with moderate sedation (7% versus 14%), with most failures resulting from inadequate sedation. It has also been reported that complication rates associated with therapeutic interventions during ERCP may be significantly lower when general anaesthesia is used, perhaps because the absence of patient movement makes the procedure technically less difficult. When general anaesthesia is administered for ERCP, the airway is protected by endotracheal intubation which may decrease risk for broncho-aspiration in some patients, although this measure has not been demonstrated to be effective in patients at risk during digestive endoscopy.
However, aspiration at the time of in/ex-tubation as well as micro-aspiration of contaminated upper airway secretions along leaks and defects of the tracheal cuff seal is not excluded if standard endotracheal tubes are used.
What may be the harms of general anaesthesia? Intubation and extubation manoeuvres may prolong endoscopic room occupation time, post-anaesthesia care unit stay may be longer and about 30 to 70% of patients will suffer from sore throat (this is reduced if lidocaine is used).
Furthermore, orotracheal intubation may induce short time hemodynamic changes related to laryngoscopy.
What may be the benefits of deep sedation? The main advantage of sedation is probably the faster turnover in the intervention room. In the sole practice survey of anesthesiologists for endoscopy that is available, 81% of anaesthesiologists stated that they were using sedation, not general anesthesia, for ERCP.
Deep sedation with propofol during digestive endoscopy has been shown to be superior to moderate sedation with a combination of benzodiazepine plus opioid in many aspects, including better patient cooperation, shorter recovery time and lower number of desaturation events.
In Switzerland, sedation during ERCP is obtained using benzodiazepines or propofol in similar proportions of cases and, when propofol is used, it is administered by the endoscopist or nurse in two thirds of cases and by the anaesthesiologist in one third of cases.
Evidence from prospective studies suggests that complex procedures, including therapeutic ERCP, may be performed safely under deep sedation without tracheal intubation using propofol, even in high-risk patients.
What may be harms of deep sedation? In a large study including nearly 10'000 patients, adverse events were observed in 1.4% of patients sedated using propofol. In that study, adverse events were defined as premature termination of the procedure due to sedation-related events (most often related to hypoxemia) or the need for assisted ventilation or, very rarely, admission to intensive care unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Sedation | Active comparator | Drug: PropofolRemifentanil 1ng/ml throughout the procedure. Propofol administration starts at an initial (estimated plasma) target concentration of 1,5 microg/ml. Propofol administration is adjusted to level 1 or 2 on the modified observer's assessment of alertness/sedation scale. The propofol infusion will be increased stepwise by 0,5 microg/ml every 1 minute until loss of consciousness. Propofol is continued while maintaining spontaneous ventilation without assistance and systolic blood pressure ≥ 60 % of baseline systolic blood pressure. |
| General Anaesthesia | Active comparator | Other: General anesthesiaGeneral anesthesia will be induced with target controlled infusion (TCI) of propofol and remifentanil as in the group "deep sedation". Suxamethonium (succinylcholine) will be used to facilitate intubation. Endotracheal tube balloon pressure will be controlled during the procedure. Ventilation will be assisted using 40% oxygen in air mixture and mechanically controlled using an anaesthetic ventilator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with scheduled therapeutic ERCP
- Written informed consent for the study protocol obtained from the patient or his/her legal representative
- Anaesthetist available for the procedure
Key exclusion criteria (15 listed)
- Mechanically ventilated patients before the procedure
- Baseline oxyhemoglobin saturation < 90%
- Baseline systolic blood pressure < 90 mm Hg
- American Society of Anaesthesiologists (ASA) physical score 5 (Table 1)
- Age < 18 years
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 | Drug | Deep Sedation |
| General anesthesia | Other | General Anaesthesia |
Primary outcome
ERCP success rate
Time frame: 24 hours
The primary study outcome will be a comparison between patient allocation groups and the percentage of completely successful ERCP. Success of ERCP is defined as achieving both high completion and low adverse event rate.
1 secondary outcome
Success of ERCP in subgroups of patients
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Recruitment too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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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.
Vincent Huberty, MD principal investigator
Gastroenterology Department Erasme Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and General anesthesia in people with Anesthesia and ERCP, run by Erasme University Hospital at 1 site in Belgium.
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 15 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: stopped early, as of the sponsor's last update on 15 Feb 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 Belgium. 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 was stopped early (reason given: Recruitment too slow). Results are not available in the source record.
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?
ERCP success rate (time frame: 24 hours). 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 15 Feb 2023.