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

NCT01277861 | Completed Phase 4 Results DMC

• 1 other identifier: 092010-013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Administration Site Reaction

Keywords

Desflurane, Fentanyl, Airway responses

Outcome Measures

Primary Outcomes (1)

• Movement

  The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).

  Induction of Anesthesia

Secondary Outcomes (2)

• Apnea

  Induction of Anesthesia

• Coughing

  Intraoperative period

Study Arms (2)

FENTANYL

ACTIVE COMPARATOR

FENTANYL

Drug: Fentanyl

SALINE

PLACEBO COMPARATOR

SALINE

Drug: Fentanyl

Interventions

Fentanyl DRUG

FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA

FENTANYL; SALINE

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[i.e., hysteroscopy\])

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Ut Southwestern Medical Center At Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Girish P. Joshi, MD
• Organization: University of Texas Southwestern Medical Center at Dallas

girish.joshi@utsouthwestern.edu

214-590-7259

Study Officials

• Girish P Joshi, MD

  University of Texas Southwestern Medical Center, Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: January 17, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 15, 2013
• Results First Posted: March 15, 2013

Record last verified: 2013-03

Locations

US (1)