Sedation for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography
Condition: Biliary Colic
Study type: Interventional

Summary: 
      This study was performed to evaluate the role of BIS monitored sedation in reducing the dose
      of propofol and to know the effectiveness of pre-procedure administration of intravenous
      diclofenac sodium along with topical pharyngeal anesthesia in reducing the dose of propofol
      in patients undergoing endoscopic retrograde cholangiopancreatography.
    

Detailed description: 
      It was a single-center open-labeled Prospective Randomized study. After approval of the study
      by the institutional ethical committee & obtaining written informed consent, 90 patients
      scheduled for ERCP procedure were randomized by using the block randomization method into the
      following three groups, Group A (n=30)-The intravenous infusion of propofol was administered
      for the ERCP procedure based on clinical judgment and the patient's requirement.

      Group B (n=30) - The intravenous infusion of propofol was administered for ERCP procedure
      titrated to BIS value 60-80.

      Group C (n=30) - Patients received 75 mg of inj. Diclofenac sodium (diluted in 100 ml of 0.9
      % normal saline) intravenously 30 mins before the start of procedure & topical pharyngeal
      anesthesia with 4 squirts of 10% lidocaine spray ( one squirt each to posterior pharyngeal
      wall, base of tongue, and bilateral palatoglossal and palatopharyngeal folds ) 5 mins before
      the start of ERCP procedure. Intravenous infusion of propofol was administered for ERCP
      procedure titrated to BIS value 60-80.

      In all three groups, after completing the standard pre-anesthesia checklist, patients were
      positioned in the semi prone-position and standard ASA monitors were attached
      (electrocardiogram, pulse oximetry, and non-invasive blood pressure, EtCO2). Also, the BIS
      monitor was attached in group B & group C. Baseline values were noted before the start of
      sedation. Supplemental oxygen was provided by nasal prongs @ 2/min. Patients in all groups
      were sedated with an initial bolus dose of fentanyl 1 mcg/kg & propofol 1-1.5 mg/kg
      intravenously. Sedation was maintained with propofol infusion at the rate of 80-100
      mcg/kg/min. In group A, propofol sedation was further titrated based on clinical judgment and
      patient's requirement. Whereas in group B & group C, propofol sedation was further titrated
      to maintain a BIS value between 60-80. If the patient moves despite BIS 60-80, an additional
      bolus of 30 mg i.v. propofol was administered. In addition to these, i.v. fentanyl 25mcg was
      administered as a rescue analgesic.All pre-procedure drugs were administered in the
      preoperative room with standard ASA monitoring.

      Hemodynamic parameters were monitored at 5-min intervals. The incidence and number of
      episodes of patient's movements, cough/gag reflex, and hiccups were noted. The incidence of
      desaturation (fall in oxygen saturation < 94 % with oxygen supplementation), hypotension (17)
      (defined as systolic blood pressure < 90 mm of Hg ), and bradycardia (defined as HR < 50
      beats per minute) was also be noted. Standard anesthesia protocol was followed for the
      management of desaturation and hemodynamic instability. Desaturation was managed by chin lift
      & jaw thrust maneuver. The nasal airway was inserted if deemed necessary by the concerned
      anesthetist. Further, if desaturation persists & lack of respiratory effort is seen for more
      than 20 seconds, sedation was discontinued, and mask ventilation is initiated in the lateral
      position. Insertion of supraglottic airway devise or tracheal intubation (after turning the
      patient supine) performed as per anesthetist discretion and the patient will be excluded from
      the study. Hypotension managed with 6-12 mg of intravenous ephedrine or a fluid bolus of 500
      cc of plasmalyte. Bradycardia is managed by 0.6 mg of intravenous atropine.

      At the end of the procedure, propofol infusion was stopped and the total dose of propofol
      administered in mg/kg/hr was calculated. Thereafter, time to achieve eye-opening to verbal
      commands was calculated.

      Post-procedure, patients were nursed in the left lateral position, and vitals (HR, NIBP,
      SpO2) was noted every 5 mins. Also, readiness to discharge is assessed by the noting
      post-anesthesia discharge score (PADS) every 15 mins. For patients having breakthrough pain,
      1 gram iv paracetamol was administered in all the groups. The endpoint of complete recovery
      was a PADS score of 10. Also at the end of the procedure, the endoscopist was asked to grade
      ease of procedure based on 1=poor, 2=fair, 3=acceptable, 4=good, 5=excellent scale.

      At the time of discharge, the patient's satisfaction for the ERCP procedure was grade on
      1=unacceptable, 2=extremely uncomfortable, 3=slightly uncomfortable, 4=no discomfort scale.
    

Intervention name(s): Propofol; Diclofenac Sodium and Lignocaine 10 % spray
Intervention type(s): Drug; Drug
Intervention description(s): Injection propofol was given to keep the BIS value 60-80 during the ERCP procedure; Injection Diclofenac sodium was given in the preoperative area 30 minutes before the procedure and four squirts of 10% lignocaine were given 5 minutes prior to the start of the procedure
Other intervention name(s): Neorof; Dynapar
Intervention MeSH terms: Diclofenac; Lidocaine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diclofenac; Propofol; Topical anaesthesia