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van CCT (UK)


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van CCT (UK)


Comparison of different forms of sedation during endoscopie of the bile ducts


- candidate number23399
- NTR NumberNTR5486
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2015
- Secondary IDsNL53999.018.15  CCMO
- Public TitleComparison of different forms of sedation during endoscopie of the bile ducts
- Scientific TitleSedation with propofol TCI during ERCP: Is the combination with esketamine more effective and safer than with alfentanil (SPEKA) A randomized controlled multicentre trial
- ACRONYMSPEKA
- hypothesisThe aim of this study is to demonstrate that procedural sedation with propofol and esketamine is more effective and will result in less cardiopulmonary depression than sedation with propofol and the opioid alfentanil. Less side effects should also lead to higher safety profiles of this sedation regime.
- Healt Condition(s) or Problem(s) studiedSedation
- Inclusion criteriaThe patients must comply with the following criteria in order to be eligible to participate in this clinical study:
Age range °› 18 years
ASA classification I ®C III
Planned ERCP procedure
Written informed consent
- Exclusion criteriaPatient will be excluded if the following criteria in the patients°°¬ medical history are applicable:
Age range < 18 years
ASA classification IV and V
Allergic reaction to planned medication
History of unregulated or malignant hypertension
Significant ischaemic heart disease
History of psychological problems or psychiatric disease
Use of drugs that affect the central nervous system
Substance abuse
Chronic pain
Pregnancy
Seizure disorders
Increased intracranial pressure
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2015
- planned closingdate1-dec-2016
- Target number of participants166
- InterventionsPatient will be randomized to two groups and will receive either an interventional propofol/esketamin sedation regime or a control propofol/alfentanil sedation regime.
- Primary outcomeThe primary objective of this study is to determine the effectiveness of propofol/esketamine compared to propofol/alfentanil sedation, both administered by anaesthetic nurses trained in procedural sedation and analgesia (PSA). Considering effectiveness there are four aspects to determine the effectiveness of the propofol/esketamine regime. First, will the synergistic combination of propofol and esketamine result in a dosage reduction of propofol? Secondly, are the levels of sedation and analgesia (without opioids) sufficient to perform the procedure? Thirdly, are patients more satisfied by the combination propofol/esketamine concerning side effects? Fourth, is recovery time shorter?
- Secondary outcomeSecondary objectives concern patient safety. Safety is thereby a synonym for a reduction in pulmonary and cardiovascular incidents and complications (hypotension, respiratory depression, hypoxemia) that could be attributed to the respective sedation regime.
- TimepointsT1: Start of induction of sedation
T2: End of induction (MOAA/S < 2)
SpO2, RR, HR, NIBD, exCO2, arrhythmia
Significant events
MOAA/S 4
T3: Start of procedure (induction scope)
SpO2, RR, HR, NIBD, exCO2, arrhythmia
Significant events
MOAA/S 4
T4:End of procedure (removing scope)
Questionnaire endoscopist: satisfaction, MOAA/S, estimation pain and ease of procedure
T5:Recovery from sedation (MOAAS >4) (ready for transport to recovery room)
SpO2, RR, HR, NIBD, arrhythmia
MOAA/S
Total doses of medications administered
T 6,7,8,9,10,11
Arrival recovery room ,15 min ,30 min, 60 min recovery,
Discharge
SpO2, RR, HR, NIBD, arrhythmia
Aldrete
Patient questionnaire part 2:
VAS score concerning pain, drowsiness, nausea, perception, and mood state

Follow up telephone call on the following day
Questionnaire patient part 3
VAS score concerning pain, drowsiness, nausea, perception, mood state, total satisfaction, physical activity
- Trial web sitenon
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD S. Eberl
- CONTACT for SCIENTIFIC QUERIESMD S. Eberl
- Sponsor/Initiator Academic Medical Center (AMC), Department of Anesthesiology, Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Anesthesiology, Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Publications
- Brief summaryEndoscopic retrograde cholangiopancreatography (ERCP) is a complex, often painful gastrointestinal procedure. Since any movement of the patient could considerably affect success of the ERCP, procedures are usually performed under deep sedation. ERCP is often combined with endoscopic ultrasound (EUS) in order to obtain images and information about the digestive tract and the surrounding tissue and organs. Over the last decade the combination of propofol and an opioid has become the standard sedative regime during ERCP in many countries, despite known side effects, such as hypotension and respiratory depression, leading eventually to severe hypoxemia. Opioids, especially when used in combination with sedative-hypnotics, can not only aggravate clinically significant respiratory depression but also increase the incidence of postoperative nausea and vomiting. Esketamine, the s-enantiomer of ketamine - is not only a well-known sedative, but also has strong analgesic properties. Furthermore, its sympathomimetic qualities can counteract the hemodynamic depression of propofol, reducing the risk of cardiovascular or respiratory depression during sedation. Esketamine could thus be a safer additive to propofol than opioids to achieve an adequate level of sedation and analgesia with less negative cardiopulmonary side effects due to reduction of the required dosage of propofol and omission of opioids.

The aim of this study is to demonstrate that procedural sedation with propofol and esketamine is more effective and will result in less cardiopulmonary depression than sedation with propofol and the opioid alfentanil. Less side effects should also lead to higher safety profiles of this sedation regime. The primary objective of this study is to determine the effectiveness of propofol/esketamine compared to propofol/alfentanil sedation, both administered by anaesthetic nurses trained in procedural sedation and analgesia (PSA). Considering effectiveness there are four aspects to determine the effectiveness of the propofol/esketamine regime. First, will the synergistic combination of propofol and esketamine result in a dosage reduction of propofol? Secondly, are the levels of sedation and analgesia (without opioids) sufficient to perform the procedure? Thirdly, are patients more satisfied by the combination propofol/esketamine concerning side effects? Fourth, is recovery time shorter? Secondary objectives concern patient safety. Safety is thereby a synonym for a reduction in pulmonary and cardiovascular incidents and complications (hypotension, respiratory depression, hypoxemia) that could be attributed to the respective sedation regime.

Patients will be randomized to an esketamine and propofol regime (interventional arm) or to an alfentanil/propofol regime (control arm) and studied during the endoscopic procedure.

Main study parameters are the total dosage of propofol, recovery time, and satisfaction with the procedure of patients and endoscopists

Secondary study parameters concerning the safety aspect, are recording of oxygen saturation (SpO2) measured by pulse oximetry, respiratory rate (RR), exhaled CO2 (capnography), heart rate (HR), arrhythmias (ECG) and non-invasive blood pressure (NIBP). These vital parameters will indicate pulmonary and cardiovascular incidents, experienced by the patient during sedation.
- Main changes (audit trail)
- RECORD17-nov-2015 - 5-jan-2016


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