Attenuation Of Hemodynamic Response To Laryngoscopy. Role Of Dexmedetomidine. A Dose Finding Study
Condition: Hemodynamic Instability; Tracheal Intubation; Dexmedetomidine
Study type: Interventional
Phase: Phase 4

Summary: 
      Two doses of Dexmedetomidine (0.5 µ/kg and 0.75 µ/kg) will be used to attenuate the stress
      response to laryngoscopy in American Society of Anesthesiology, physical class I patients
      which will be compared with the placebo-controlled group.
    

Detailed description: 
      A randomized, double-blind controlled trial will be conducted to determine the attenuation of
      stress response caused by laryngoscopy and tracheal intubation (LTI). After the Institutional
      Ethics Committee approval, (Sindh Institute of Urology and Transplantation, Pakistan),
      written informed consent will be obtained from 105 adult patients.

      Randomization will be done using a computer-generated random number table. Patients will be
      divided into three groups. Group A "Placebo group", will receive 20 mL of normal saline (NS),
      Group B "dexmedetomidine 0.5", will receive dexmedetomidine 0.5 μ/kg, whereas, Group C
      "dexmedetomidine 0.75", will receive dexmedetomidine 0.75 μ/kg, all as a 20mL infusion
      through a syringe pump over 10 minutes followed by induction of general anesthesia.

      No premedication will be given in the ward. Once the patients will arrive in the operating
      room, routine monitoring (electrocardiogram, pulse oximetry, non-invasive blood pressure)
      will be started. After recording the baseline vitals and Ramsay sedation score, the study
      drug or normal saline (according to randomization) will be given in a look-alike syringe over
      10 minutes. The study drug will be prepared as a 20 mL solution in a 25 mL syringe. An
      independent co-investigator (anaesthesiologist) who will not be involved in administering
      general anesthesia or recording the study parameters will prepare the study drug(s) according
      to the body weight or NS using identical-looking syringes. Study drug infusion will be
      started once the patient is taken to the operating table. Vitals and sedation scores will be
      recorded at 0,1,3,5 and 10 minutes during infusion. Investigators will keep the atropine
      drawn in a syringe and ready to be given in case of heart rate goes below 40 beats/min.
      Ephedrine (5mg/ml) and adrenaline 10µ/ml will also be ready for use.

      Once completing the infusion, general anesthesia will be administered using a standard
      protocol (Nalbuphine 0.15 mg/kg, Propofol 2.5 mg/kg, Atracurium 0.6 mg/kg after assessing
      easy bag-mask ventilation in all patients. After 3-minute bag-mask ventilation with
      Isoflurane at 1.5% in 100% oxygen, the trachea will be intubated by one of three senior
      anaesthesiologists involved in this study. The intubating duration will be kept below 15
      seconds. Hemodynamic monitoring will be continued for another 10 minutes at 1, 3, 5 and 10
      minutes after intubating the trachea.
    

Intervention name(s): Normal saline; Dexmedetomidine 0.5 microgram/kg; Dexmedetomidine 0.75 microgram/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Normal saline 20mL will be given intravenously through a syringe pump over 10 minutes; Dexmedetomidine 0.5 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes; Dexmedetomidine 0.75 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes
Other intervention name(s): Placebo group
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systolic Blood Pressure; Diastolic Blood Pressure; Heart Rate; Mean Arterial Pressure; Precedex; Tracheal Intubation; Laryngoscopy; Sedation