Clinical trial

Comparison Between Inhalational Anesthetic (Sevoflurane) and Intravenous Anesthetic (Propofol Infusion) for Maintenance of Sedation During Endoscopic Retrograde Cholangiopancreatography

Name
SIUT-ERC-2021/A-325
Description
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
Trial arms
Trial start
2022-01-05
Estimated PCD
2022-11-25
Trial end
2022-11-25
Status
Completed
Phase
Early phase I
Treatment
Propofol 1 % Injectable Suspension
Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously
Arms:
Propofol
Other names:
Propofol
Sevoflurane
Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25
Arms:
Sevoflurane
Other names:
Sevoflurane inhalation anaesthetic
Size
86
Primary endpoint
Ramsay sedation score
0-2 hours
Heart rate
0-2 hours
Mean arterial blood pressure
0-2 hours
Oxygen saturation
0-2 hours
Respiratory rate
0-2 hours
Eligibility criteria
Inclusion Criteria: * Patients between age group of 20-60 years * Both male and female patients. * American Society of Anesthesiologist (ASA) physical status I-II * Elective ERCP procedure. Exclusion Criteria: * Patients allergic to any study drug. * American Society of Anesthesiology (ASA) Physical status III-IV * Patients with uncontrolled Diabetes Mellitus, * Hypertension and renal insufficiency. * Body mass index (BMI) over 36 Kilogram/m2 (Morbid obesity) * Obstructive Sleep Apnea * Gastroesophageal reflux disease (GERD) * Pregnancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 86, 'type': 'ACTUAL'}}
Updated at
2023-08-18

1 organization