Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment

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.

Study Overview

• Status: Completed
• Conditions: Administration Site Reaction
• Intervention / Treatment: Drug: Fentanyl

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-64 years of age
• Subjects scheduled for elective superficial and peripheral surgery of less than 2 h duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery, superficial abdominal/chest wall surgery [i.e., lipoma], minor gynecological procedures [i.e., hysteroscopy])

Exclusion Criteria:

• 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
• history of alcohol and drug abuse
• requiring tracheal intubation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FENTANYL	Drug: Fentanyl; FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA
Placebo Comparator: SALINE	Drug: Fentanyl; FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement	The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).	Induction of Anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea	Apnea defined as no breathing for at least 30 s.	Induction of Anesthesia
Coughing	Data include patients who coughed irrespective of the degree of coughing.	Intraoperative period

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Girish P Joshi, MD, University of Texas Southwestern Medical Center, Dallas

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: January 13, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 15, 2013
• Last Update Submitted That Met QC Criteria: March 14, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Desflurane, Fentanyl, Airway responses
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 092010-013