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
  Purpose

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.


Condition Intervention Phase
Administration Site Reaction
Drug: Fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FENTANYL
FENTANYL
Drug: Fentanyl
FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA
Placebo Comparator: SALINE
SALINE
Drug: Fentanyl
FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277861

Locations
United States, Texas
Ut Southwestern Medical Center At Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Baxter Healthcare Corporation
Investigators
Principal Investigator: Girish P Joshi, MD University of Texas Southwestern Medical Center, Dallas
  More Information

No publications provided

Responsible Party: Girish P Joshi, MD, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01277861     History of Changes
Other Study ID Numbers: 092010-013
Study First Received: November 3, 2010
Results First Received: February 16, 2012
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Desflurane, Fentanyl, Airway responses

Additional relevant MeSH terms:
Anesthetics
Fentanyl
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on September 29, 2014