Evaluation of a New Protocol for Adult Procedural Sedation With Ketamine-propofol in a 1 on 4 Ratio
- Conditions
- Procedural Sedation and Analgesia
- Interventions
- Drug: Procedural sedation with ketofol in a 1 on 4 ratio
- Registration Number
- NCT04028141
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Procedural sedation is the monitored use of sedatives and/or analgesics in a patient who must endure a short painful or frightening procedure, bringing the patient into a sedative state while retaining his spontaneous breathing and respiratory reflexes. Examples of these procedures are cardioversion, repositioning of a shoulder luxation or incision of a skin abscess, and these are frequently performed at the emergency ward. An easy and unambiguous protocol for procedural sedation was composed at the emergency department of the University Hospital of Ghent applicable for nearly all patients and procedures. This protocol included recommendations for necessary monitoring such as continuous electrocardiogram, intermittent blood pressure measurements, oxygen saturation and capnography, as well as safety precautions for standby medications or medical devices for hemodynamic and airway control. As sedative drug a mixture of ketamine and propofol ("ketofol") in a 1 on 4 ratio was selected based on the available literature. Both ketamine and propofol are known to neutralise each other's undesirable effects and ketamine adds an analgesic quality. Ketofol has proven effective and safe in studies and is non-inferior to propofol. Though it is most often used in a 1 on 1 ratio, both pharmacological and clinical studies favour a 1 on 4 ratio.
An adult patient presenting at the investigating hospital in need of procedural sedation, who agreed the informed consent for procedural sedation was treated according to this protocol. Patients with an American Society of Anesthesiologist physical status classification system status of III or more, with an anticipated difficult airway or intoxicated patients were discussed with the anaesthesiology department to decide the feasibility of sedation in the emergency ward setting. Pregnant patients were excluded.
Associated to this newly implemented protocol, an observational prospective study was associated to verify the safety and effectivity, and to score the physicians satisfaction. A separate informed consent was obtained for participation in the study to permit inclusion of patient and procedural data into a registry. Data was registered by the physician responsible for the sedation in a questionnaire. The investigators hypothesized the protocol with ketofol in a 1 on 4 ratio would be safe and effective and would serve to facilitate procedural sedation by emergency physicians.
- Detailed Description
Procedural sedation is the monitored use of sedatives and/or analgesics in a patient who must endure a short painful or frightening procedure, bringing the patient into a sedative state while retaining his spontaneous breathing and respiratory reflexes. Examples of these procedures are cardioversion, repositioning of a shoulder luxation or incision of a skin abscess, and these are frequently performed at the emergency ward. An easy and unambiguous protocol for procedural sedation was composed at the emergency department of the University Hospital of Ghent applicable for nearly all patients and procedures. This protocol included recommendations for necessary monitoring such as continuous electrocardiogram, intermittent blood pressure measurements, oxygen saturation and capnography, as well as safety precautions for standby medications or medical devices for hemodynamic and airway control. As sedative drug a mixture of ketamine and propofol ("ketofol") in a 1 on 4 ratio was selected based on the available literature. Both ketamine and propofol are known to neutralise each other's undesirable effects and ketamine adds an analgesic quality. Ketofol has proven effective and safe in studies and is non-inferior to propofol. Though it is most often used in a 1 on 1 ratio, both pharmacological and clinical studies favour a 1 on 4 ratio. According to the protocol ketofol 1 on 4 was prepared by mixing 1ml of ketamine (50mg) and 20ml of propofol (200mg) in a single syringe and administrated as a loading dose of 1ml/10kg, followed by a stepwise titration in aliquots of 0,5ml/10kg. Above 65 years the loading dose was halved.
An adult patient presenting at the investigating hospital in need of procedural sedation, who agreed the informed consent for procedural sedation was treated according to this protocol. Patients with an American Society of Anesthesiologist physical status classification system status of III or more, with an anticipated difficult airway or intoxicated patients were discussed with the anaesthesiology department to decide the feasibility of sedation in the emergency ward setting. Pregnant patients were excluded.
Associated to this newly implemented protocol, an observational prospective study was associated to verify the safety and effectivity, and to score the physicians satisfaction. A separate informed consent was obtained for participation in the study to permit inclusion of patient and procedural data into a registry. Data was registered by the physician responsible for the sedation in a questionnaire. The investigators hypothesized the protocol with ketofol in a 1 on 4 ratio would be safe and effective and would serve to facilitate procedural sedation by emergency physicians.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- All adult patients presenting to the university hospital of Ghent and in need of procedural sedation as determined by the treating physician, who underwent procedural sedation by the standard protocol using ketofol in a 1 on 4 ratio.
- pregnant patient
- procedural sedation not performed at the emergency department
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description participants undergoing procedural sedation Procedural sedation with ketofol in a 1 on 4 ratio The study gathered observational data about participants who underwent procedural sedation according to the new standard protocol with ketofol in a 1 on 4 concentration. The participant was observed for complications or cardiorespiratory interventions by the sedating physician until he was fully awake. Thirty minutes after the awakening, the participant was questioned for his remembrance and perception of the sedation and procedure. He was observed for complications until discharge
- Primary Outcome Measures
Name Time Method Hemodynamic complication or intervention From start of sedation, until half an hour after participant woke up from sedation ( participant fully communicative and obedient for commands). On average a total monitoring time of 40 minutes. * Complication: hypotension (systolic blood pressure less than 90mmHg, or drop of 10% of systolic blood pressure )
* Intervention: fluid bolus given, use of inotropesRespiratory complication or intervention From start of sedation, until half an hour after participant woke up from sedation ( participant fully communicative and obedient for commands). On average a total monitoring time of 40 minutes. * Complication: desaturation (\< 92%), apnea (absent end-tidal CO2 for \> 15s and no breathing movements), hypoventilation (respiratory frequency \< 8 /minute), airway obstruction (absent end-tidal CO2 for \> 15s and breathing movements), laryngospasm (partial or complete airway obstruction, not responding to airway repositioning or introduction of naso- or oropharyngeal cannula), aspiration due to vomiting
* Intervention: airway repositioning (head tilt or chin lift), pain stimulus for breathing stimulation, introduction of naso- or oropharyngeal cannula, positive pressure ventilation, introduction of laryngeal mask or endotracheal tube
- Secondary Outcome Measures
Name Time Method Success of procedure From start of sedation, until participant woke up from sedation ( participant fully communicative and obedient for commands). Assessment was made at time of awakening sedation adequate for performing procedure (yes/no)
Agitation or hallucination From start of sedation, until half an hour after participant woke up from sedation ( participant fully communicative and obedient for commands). On average a total monitoring time of 40 minutes. * Agitation during or after sedation (yes/no)
* Hallucination during or after sedation (yes/no)
* If hallucination: Pleasant / neutral / unpleasantAmnesia Assessed 30 minutes after awakening ( participant fully communicative and obedient for commands) and addressing the moment of performance of the procedure during sedated state amnesia of the procedure by the patient (yes/no)
Duration of sedation Start of sedation until awakening ( participant fully communicative and obedient for commands) Time from start of sedation till completely awake, expressed in minutes
Satisfaction sedating physician Assessed 30 minutes after awakening ( participant fully communicative and obedient for commands), concerning the period from start of sedation until 30 minutes after awakening - satisfaction of the sedation with the current protocol, score on a five point Likert scale (++ / + / + - / - / - - , meaning very satisfied / satisfied / neither satisfied nor dissatisfied / dissatisfied / very dissatisfied )
Trial Locations
- Locations (1)
University Hospital of Ghent - Emergency Department
🇧🇪Ghent, East-Flanders, Belgium