Comparison Between Sevoflurane and Propofol for Maintenance of Sedation During ERCP
Condition: Sedation Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Propofol 1 % Injectable Suspension; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Propofol 1 % Injectable Suspension at a rate of 50 microgram/kg/min intravenously; Sevoflurane inhalation anaesthetic at a concentration of 4-5% to achieve a MAC of 0.25
Other intervention name(s): Propofol; Sevoflurane inhalation anaesthetic
Intervention MeSH terms: Propofol; Anesthetics; Sevoflurane; Anesthetics, Inhalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment