Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.
Condition: Cholecystectomy; Elective Surgery
Study type: Interventional

Summary: 
      Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation
      response in a patient undergoing laparoscopic cholecystectomy.

      Compare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative
      complications, and recovery in these patients.

      Dexmedetomidine is comparatively a newer drug in countries like Pakistan. There is no
      research work available at the national level and scarcity of data at an international level
      with inconclusive outcomes. Our participation in the form of this research will add to
      scientific literature and step up ahead at the international level.

      Fentanyl citrate is a narcotic analgesic interacting predominantly with the opioid μ receptor
      and exerting its principal pharmacological effect on CNS. Its primary action of therapeutic
      value is analgesia and sedation. It is extensively used for anesthetic and analgesic most
      often in operating room and ICU.
    

Detailed description: 
      This is double-blind, a single centered randomized clinical trial which is based on assessing
      the hemodynamic stability provided by our study drugs during laryngoscopy and intubation in a
      patient undergoing laparoscopic cholecystectomy. In addition to that this study will assess
      the perioperative complication and postoperative recovery in these patients. Laparoscopy has
      now become the standard technique of choice for cholecystectomy which results in
      pathophysiological changes characterized by an increase in arterial pressure and heart rate
      (HR). Many types of research have been done in an attempt to minimize adverse effects by
      adding adjuvants to the conventional method of general anesthesia. Our research is also based
      on this aim. The objective of this study to determine the hemodynamic stability during
      laryngoscopy and intubation, peri-operative complication and post-operative recovery. The
      patients will be divided into two groups randomly and will be given the desired drugs via
      intravenous line by on floor consultant anesthetist who will be blinded to the drug. The
      study subjects' hemodynamics will be observed until 10 minutes of intubation. Any
      perioperative complication will be noted. The subjects will also be followed postoperatively
      in recovery to check there sedation score and recovery (Aldrete score) will be noted after 10
      minutes after the patient shifted to recovery.
    

Intervention name(s): Dexmedetomidine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%; intravenous fentanyl at 2mcg/kg in 100ml saline
Other intervention name(s): Fentanyl; Dexmedetomidine
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT, Double-blind, Randomized control trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Laparoscopic Cholecystectomy; Dexmedetomidine; Fentanyl; Hemodynamics response; Direct laryngoscopy; Intubation