Dexmedetomidine Versus Ketofol for Moderate Sedation in Endoscopic Retrograde Cholangiopancreatography
Condition: Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients were randomly divided into Dexmedetomidine or Ketofol for sedation. In patients who
      received Dexmedetomidine, a 2ml ampule of 100 ug/ml was diluted in 18 ml of normal saline,
      making a total volume of 20 ml. Patients received dexmedetomidine as a bolus over 10 minutes
      in a dose of 1ug/kg followed by an infusion at the rate of 0.5ug/kg/hr and it was labeled as
      "infusion 1". In the Ketofol group, 2 ml ketamine (50mg/ml) and 10 ml of propofol 1%
      (10mg/ml) were diluted in 8ml of normal saline. This mixture was 20 ml each, making 5mg/ml of
      ketamine and propofol. Patients received 1mg/kg over 10 minutes followed by 50ug/kg/min of
      infusion, labeled as "infusion 2".
    

Detailed description: 
      Patients aged 20-60 years of any gender scheduled for elective ERCP were included. All these
      patients had American Society of Anesthesiologists (ASA) classification I or II. While those
      who were allergic to dexmedetomidine, Ketofol, or related medications, BMI over 36 kg/m2
      (morbidly obese), had a history of stroke, renal impairment, chronic obstructive pulmonary
      disease, asthma, chronic liver disease, hypothyroidism, and congestive cardiac failure were
      excluded. Furthermore, pregnant, or breastfeeding women or patients who reported chronic use
      of sedative medications or substance abuse, known contraindications to ERCP, and already
      enrolled in another clinical trial study were excluded.

      Patients were randomly divided into two groups using computer randomization. All patients
      were taken to the procedure room and venous access was secured on a non-dominant hand by 20G
      IV cannula, intravenous (I/V) fluid (ringer lactate or normal saline) was started by 8
      ml/kg/h, and oxygen support was provided by nasal cannula at 4 liters per minute. Standard
      monitors were attached for heart rate (HR), noninvasive blood pressure (systolic and
      diastolic), mean arterial blood pressure (MAP), and peripheral oxygen saturation SpO2.
      Injection midazolam 0.05 mg/kg was also given I/V to every patient in both groups to decrease
      the anxiety of patients.

      Patients received either Dexmedetomidine or Ketofol for sedation. All syringes and infusion
      sets were covered by silver paper and these infusions were labeled as infusion 1 or 2. In
      patients who received Dexmedetomidine, a 2ml ampule of 100 ug/ml was diluted in 18 ml of
      normal saline, making a total volume of 20 ml. Patients received dexmedetomidine as a bolus
      over 10 minutes in a dose of 1ug/kg followed by an infusion at the rate of 0.5ug/kg/hr and it
      was labeled as "infusion 1". In the Ketofol group, 2 ml ketamine (50mg/ml) and 10 ml of
      propofol 1% (10mg/ml) were diluted in 8ml of normal saline. This mixture was 20 ml each,
      making 5mg/ml of ketamine and propofol. Patients received 1mg/kg over 10 minutes followed by
      50ug/kg/min of infusion, labeled as "infusion 2".

      During infusion, vitals were recorded at 0,1,3,5, and 10-minute intervals from the start, and
      the Ramsay Sedation scale score (RSS) was recorded every 1 minute. Both infusions were
      started as per the randomization of groups. The mean difference in time to achieve adequate
      sedation and time to good recovery were noted as outcomes in each group. In addition,
      complications during the procedure and recovery were also noted. Adequate sedation was
      defined as the time from initiation of infusion to achieve an RSS score of 4. While Modified
      Aldrete's score (MAS) was used to assess the recovery. Time from discontinuation of the
      infusion to achieve an MAS score of 9 was labeled as a good recovery.
    

Intervention name(s): Dexmedetomidine; Ketofole
Intervention type(s): Drug; Drug
Intervention description(s): Patients received dexmedetomidine as a bolus over 10 minutes in a dose of 1ug/kg followed by an infusion at the rate of 0.5ug/kg/hr; Patients received ketofol 1mg/kg over 10 minutes followed by 50ug/kg/min of infusion
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment