Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment
Condition: Administration Site Reaction
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators plan to test the hypothesis that pretreatment with fentanyl prior to
      induction of anesthesia would result in reduce the incidence of movements and airway
      responses to desflurane in patients breathing spontaneously through a laryngeal mask airway
      (LMA). The primary aim of this study is to assess the effect of fentanyl pretreatment on the
      incidence of movement during induction of anesthesia. Secondary aim of the study is to
      evaluate the effects of titration of fentanyl according to the respiratory rate on the
      incidence of intraoperative respiratory events such as coughing, breath holding and
      laryngospasm.
    

Detailed description: 
      After obtaining approval from the institutional review board and informed consent, 100
      patients, 18-64 years of age, scheduled for elective superficial and peripheral surgery of
      less than 2 h duration would be enrolled in this prospective, randomized, double-blind,
      placebo-controlled study. Patients will be randomly assigned to one of two anesthetic
      techniques according to a computer-generated random numbers table. Patients will receive
      either fentanyl or saline prior to induction of anesthesia, while the rest of the anesthetic
      and analgesic technique will be standardized for all patients.

      Exclusion criteria will include obesity (body mass index >30), pregnancy, history of
      gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive
      airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease as well as
      history of alcohol and drug abuse as well as those requiring tracheal intubation.

      After premedication with midazolam 2 mg, patients will be transferred to the operating room.
      On arrival in the operating room standard monitors and the BIS (BiSpectral Index)monitor will
      be applied. Patients will then be preoxygenated for 2-3 minutes with 100% oxygen, which will
      be followed by administration of either fentanyl 1 µg/kg (made up to 10 ml saline) or 10 ml
      saline (prepared by a person not involved in the study). Induction of anesthesia will be
      performed 2-3 minutes after administration of the study drug with propofol 2.0 - 2.5 mg/kg
      after lidocaine 2% 20-30 mg. After loss of eyelash reflex an appropriate size LMA will be
      placed. If the patients become apneic, manual ventilation will be performed with
      oxygen/nitrous oxide and desflurane, 3% dialed concentration initially and then titrated to
      maintain the BIS value of 50-60.

      Anesthesia will be maintained with desflurane titrated to achieve a BIS value of 50-60, along
      with 50% nitrous oxide and oxygen. Once spontaneous breathing resumes, fentanyl 25-50 µg will
      be administered to achieve a respiratory rate of 10-15 breaths/minute. Additional
      propofol/fentanyl will be administered, if deemed necessary by the attending
      anesthesiologist. All patients will receive dexamethasone 4 mg, IV after induction of
      anesthesia and ondansetron 4 mg 20-30 minutes prior to the end of surgery. Desflurane will be
      discontinued after closure of the surgical wound.

      A blinded observer will record patient demographics (age, weight, height) and history of
      smoking from preoperative evaluation. Data collected during the intraoperative period will
      include need for manual ventilation and duration of manual ventilation, duration of
      anesthesia, total doses of propofol and fentanyl, and time from discontinuation of desflurane
      until patient first follows verbal command as well as heart rate (HR), mean arterial blood
      pressure (MAP), end-tidal carbon dioxide, oxygen saturation, and end-tidal gas concentration
      will be recorded every 15 minutes.

      Data collected in the postoperative period will include verbal rating score (0 to 10) will be
      used to assess pain, nausea, and vomiting in the recovery room every 15 minutes for one hour
      as well as the need for rescue medications will also be recorded.

      Patients will also be contacted approximately 24 hours after surgery to evaluate their post
      operative course including occurrence of any adverse events. The patient will remain in the
      study for approximately 24 hours.
    

Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Desflurane, Fentanyl, Airway responses