Hypoxia, Sedation
Conditions
Keywords
Cholangiopancreatography, Endoscopic Retrograde, Sedation
Brief summary
Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP) to alleviate discomfort and pain during the procedure. This is usually achieved with use of opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally benzodiazepines have been used but nowadays propofol is becoming the drug of choice for sedation during ERCP. The problem with propofol sedation is the fact that it may case cardiorespiratory depression and there is no antidote for this like there is for benzodiazepines. Cardiovascular depression can usually be easily counteracted with drugs that are used to raise blood pressure or heart rate during general anesthesia but respiratory depression remains a problem. The aim of this study is to try to counteract the respiratory depression caused by propofol sedation using an old respiratory stimulant doxapram as opposed to placebo using a double blind randomized protocol. The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the respiratory depression caused by propofol sedation.
Interventions
DRUGDoxapram
DRUGPlacebo
An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* \< 75 year of age * Having ERCP * Agrees to take part in the study
Exclusion criteria
* \>75 years of age * allergy to propofol or doxapram * epilepsy * Chronic Obstructive Pulmonary disease (COPD) * Coronary artery disease (symptomatic) * alcoholism * declines to take part in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in arterial oxygenation | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward | Hypoxemia, oxygen saturation by pulse oximetry (SpO2 \<90%), considered as a significant change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in systolic arterial pressure | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward | A drop of systolic arterial pressure to \<90 mmHg is considered significant |
| Pulse (heartbeats/minute) | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward | — |
| breathing rate (breaths/minute) | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sedation scales | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure | Modified observer's assessment of Alertness/sedation (MOAA(S) and Bispectral Index (BiS) |
| End-tidal carbon dioxide (CO2) | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure | A sampling catheter is placed in the nostril |
| Patient satisfaction | in the recovery room before discharge to ward | The patient is asked to rate satisfaction to the given sedation on a seven step scale ranging from extremely dissatisfied to extremely satisfied |
| operating physician satisfaction | at the end of the procedure | The operating physician is given a questionnaire and rates the following on a 4 step scale each: ease of applying the endoscope, patient co-operation, gagging/vomiting, coughing, belching, distracting movement of the patient. Also difficulty of the procedure is rated on a three step scale |
Countries
Finland
Outcome results
None listed