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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketofol group | Experimental | Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. Will receive Ketofol (ketamine: propofol concentration 1:4) prepared in 50 ml syringe containing dextrose 5% (each ml contained 8 mg propofol and 2 mg ketamine), administered as following; 5 ml of ketofol as loading then infusion titrated till targeted RSS score. |
|
| Propofol group | Active Comparator | Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine/Propofol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ketofol in sedation | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of ketofol on hemodynamics | Heart rate (beats/min) | 24 hours |
| Impact of ketofol on oxygen saturation | Pulse oximeter (SO2) | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haidi Ramadan, Phd | Contact | +201028186710 | haidikaram@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Haidi Ramadan, PhD | faculty of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Recruiting | Asyut | 71515 | Egypt |
Direct contact with the PI
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Propofol | Drug | 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. |
|
| Impact of ketofol on hemodynamics | Blood pressure(mmHg) | 24 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |