Conscious Sedation Failure During Procedure
Conditions
Brief summary
Endoscopic Retrograde Cholangiopancreatography (ERCP) is a lengthy and uncomfortable procedure that requires adequate sedation. Propofol is the commonly used sedative during ERCP. However, dose dependent cardiac and respiratory depression may occur. Hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. The aim is to study the efficacy and safety of ketofol as a sedative during urgent ERCP for severe cholangitis.
Detailed description
This randomized controlled trial was carried out on 96 patients undergoing urgent ERCP for severe cholangitis. Patients were allocated into two groups; group 1: received ketofol and group 2: received propofol. Demographic data, ERCP duration, recovery time, heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation, Ramsey Sedation Scale (RSS), pain Numerical Rating Scale (NRS), propofol requirement, adverse events, endoscopists and patients satisfaction were recorded
Interventions
DRUGKetamine/Propofol
The level of sedation was assessed at 1-3 min intervals, and the infusion rate was adjusted accordingly to achieve a Ramsay Sedation Scale (RSS) score of 5. Any movement of the patient was treated by increasing infusion rate and the infusion was discontinued at the end of the procedure. The total propofol consumed was calculated and the recovery time was recorded and calculated as the time from discontinuation of infusion of the study drug till achievement of RSS score of 3. Then patients were discharged to post-anesthesia care unit (PACU) after attaining an Aldrete Recovery Scale Score of 9- 10 \[19\]. Time taken to achieve this score was also recorded.
DRUGPropofol
Sedation was initially started by bolus dose of 0.5 mg/kg propofol IV over 3 minutes then, infusion was started at the rate of 50 µg /kg/min till RSS score of 5.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Severe acute cholangitis of either sex * Aged between 21-70 years * Undergoing urgent therapeutic ERCP for severe cholangitis with American Society of Anaesthesiologist (ASA) Grade II - III.
Exclusion criteria
* Patients who had ASA physical status Grade VI, * Baseline SpO2 \<90%, * Patients who had difficulty in communication, * Patients allergic to the studied medications, * Morbidly obese patients, * Patients with chronic obstructive pulmonary disease, * Complicated airway, * Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of ketofol in sedation | 24 hours | The time to reach Ramsay Sedation Scale score of 5 to ensure adequate sedation. This scale is between 1-6. The score 5 and 6 indicates adequate sedation while score \<5 indicates inadequate sedation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of ketofol on hemodynamics | 24 hours | Heart rate (beats/min) |
| Impact of ketofol on oxygen saturation | 24 hours | Pulse oximeter (SO2) |
Countries
Egypt
Contacts
Primary ContactHaidi Ramadan, Phd
Outcome results
None listed