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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Girish P Joshi, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01277861
First received: November 3, 2010
Last updated: March 14, 2013
Last verified: March 2013

November 3, 2010
March 14, 2013
January 2011
June 2011   (final data collection date for primary outcome measure)
Movement [ Time Frame: Induction of Anesthesia ] [ Designated as safety issue: No ]
The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).
assess the effect of fentanyl pretreatment on the incidence of coughing during induction of anesthesia [ Time Frame: PRIOR TO START OF ANESTHESIA (average of upto 24 hours from begginning of anesthesia to patient discharge) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01277861 on ClinicalTrials.gov Archive Site
  • Apnea [ Time Frame: Induction of Anesthesia ] [ Designated as safety issue: No ]
    Apnea defined as no breathing for at least 30 s.
  • Coughing [ Time Frame: Intraoperative period ] [ Designated as safety issue: No ]
    Data include patients who coughed irrespective of the degree of coughing.
Secondary aim of the study is to evaluate the effects of titration of fentanyl according to the respiratory rate on the incidence of intraoperative coughing and pain in the immediate postoperative period (i.e., in the PACU). [ Time Frame: PACU (average from 15 minutes after end of surgery upto a maximum of 2 hours after end of surgery) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Administration Site Reaction
Drug: Fentanyl
FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA
  • Active Comparator: FENTANYL
    FENTANYL
    Intervention: Drug: Fentanyl
  • Placebo Comparator: SALINE
    SALINE
    Intervention: Drug: Fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01277861
092010-013
Yes
Girish P Joshi, MD, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Baxter Healthcare Corporation
Principal Investigator: Girish P Joshi, MD University of Texas Southwestern Medical Center, Dallas
University of Texas Southwestern Medical Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP