Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Patients
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether a single bolus dose of dexmedetomidine
      administered during bariatric surgery has any effect on the amount of narcotic pain
      medications required by an individual after surgery. Patients who undergo weight loss surgery
      will be randomized into two groups - group one -dexmedetomidine group and group two- control
      group. Both groups will receive a standard anesthetic. Control group will receive weight
      based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen
      (non-narcotic pain reliever), and 60ml saline. Experimental group will receive weight based
      dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic
      pain reliever), and dexmedetomidine (given as 1mcg/kg over 10 minutes Intravenous). The
      Patient will then awaken after surgery in post anesthetic recovery unit and be given a
      patient controlled analgesia (PCA) pump with hydromorphone (long acting narcotic pain
      reliever). The amount of hydromorphone used will be recorded by the PACU nurse to the
      electronic health record ( routine practice) in the two groups and compared for pain medicine
      requirements. Secondary endpoints will be Visual Analog Score (VAS) pain score, respiratory
      rate, heart rate, blood pressure oxygen saturation and respiratory rate. All will be recorded
      at 30,60,90,120 and 240 minutes in the electronic medical record in PACU and compared between
      the two groups . All the data - Intra operative and Post -operative - Post Anesthesia Care
      Unit ( PACU) data will be retrieved from the electronic Medical record (EMR). All
      intra-operative data is automatically computed into the patients EMR. All PACU data is
      routinely entered into the EMR by the PACU nurse including the PCA data.
    

Detailed description: 
      This study will evaluate the postoperative opioid sparing effects of dexmedetomidine given as
      single bolus dose intraoperatively. Dexmedetomidine is an agonist of α2-adrenergic receptors
      sedative medication used by intensive care units and anesthesiologists and is unique in its
      ability to provide sedation without causing respiratory depression. Recently, it has received
      attention for its potential for additive analgesia. The study population will be patients
      undergoing gastric bypass surgery. The study population of bariatric surgery patients was
      chosen due to high prevalence of sleep apnea and Pickwickian component that can be worsened
      with opioid analgesia in the postoperative period. The purpose of the study is to test
      whether the use of a single bolus dose dexmedetomidine in addition to standard dose pain
      regimen decreases postoperative narcotic requirements when compared to standard dose pain
      regimen alone. The secondary purpose is to study whether single bolus dose dexmedetomidine
      reduces respiratory rate, heart rate, systolic and mean blood pressure, patient PCA demand
      bolus requests and VAS pain scores in the postoperative period. The overall goal of the study
      is to establish evidence of dexmedetomidine's role in multimodal pain relief in the bariatric
      surgery population with the possibility of other patient subgroups to follow
    

Intervention name(s): Dexmedetomidine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure; 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Postoperative narcotic requirements; Dexmedetomidine; Bariatric Surgery