Syed Muhammad Abbas
Karachi, Sindh, 74200, Pakistan
NCT Number: NCT05996588
After approval of ethical committee of Sindh Institute of Urology & Transplantation (SIUT), 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kg/min started for maintenance of anaesthesia. Ketamine 0.5mg/kg intravenously was used to rescue the sedation level in both groups
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Notify Me20 year–60 year
All sexes
Interventional
Phase 4
Karachi, Sindh, 74200, Pakistan
After approval of ethical committee of SIUT, 86 patients were enrolled for the elective endoscopic retrograde cholangiopancreatography (ERCP). Pre-operative assessment was done by history of patients, general physical examination, systematic examination, and laboratory investigations. Randomization was done by a computer-generated randomization table. Patients were divided in two groups based on agents used for the research study. Both the groups were induced by injection midazolam 0.06 mg/kg body weight and injection nalbuphine 0.1 mg/kg body weight. In group A, anesthesia was maintained by Sevoflurane inhalation via nasal prongs with oxygen to achieve minimum alveolar concentration (MAC) approximately 0.25%. Whereas, in Group B propofol infusion at 50 ug/Kilogram/min started for maintenance of anaesthesia.
When Ramsay Sedation Scale 5 is achieved then the endoscopist was allowed to insert endoscope. Injection Ketamine 0.5 mg/kg body weight was used for rescue sedation level. Upon arrival in operation theatre standard monitoring which includes pulse oximeter (SPO2), noninvasive blood pressure (NIBP), electrocardiogram (ECG) electrodes were applied, and baseline readings will be recorded. After that venous access was secured on a non-dominant hand by 20 Gauge IV cannula. Ringer's lactate or normal saline was then started at 8 ml/kg/hour and O2 was given by nasal prongs at 4 L/min. All baseline parameters were taken, after that readings were taken at 5 min, 10 min, 15 min, 20 min and so on till procedure ends.
Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded during the procedure and treated accordingly. If SpO2 went down below 92% for more than 10 seconds or patient developed apnea, it was considered oxygen desaturation.
Oxygen desaturation was managed by O2 inhalation and supporting airway. A heart rate under 40 beats per minute was considered bradycardia and it will be managed by inj Atropine 10 ug/Kilogram intravenously (I/V). Mean arterial pressures level that is lower than 60 mmHg or 20% less than the baseline was regarded as hypotension and it was managed by fluid bolus or vasopressors.
After the procedure, patients were awakened and shifted to recovery room. Complications such as respiratory depression, coughing, gagging, nausea and vomiting were recorded and treated accordingly.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously
Other names: Propofol
Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25
Other names: Sevoflurane inhalation anaesthetic
Time frame: 0-2 hours
Clinical Score Patient's Characteristics
Time frame: 0-2 hours
Heart rate via vitals monitoring device
Time frame: 0-2 hours
Mean arterial blood pressure via a non-invasive blood pressure monitor
Time frame: 0-2 hours
Oxygen saturation via a pulse oximeter
Time frame: 0-2 hours
Respiratory rate via a vitals monitoring device
Time frame: 0-2 hours
Feeling of patient to vomit out
Time frame: 0-2 hours
Expulsion of stomach contents
Sindh Institute of Urology and Transplantation
Other
Comparison Between Inhalational Anesthetic (Sevoflurane) and Intravenous Anesthetic (Propofol Infusion) for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography
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