Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

NCT01749631 | Completed Results

• 1 other identifier: P13-805
• Study Type: observational
• Target: 97
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to record the effectiveness of sevoflurane for intubation in Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards to the rate of intubation success.

Conditions

Intubation; Difficult

Keywords

Patients suspected to have difficult intubation; Intratracheal intubation; Difficult to intubate

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Successful Intubation (Clinical Success)

  Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.

  Start of intubation to completion of intubation (up to 15 minutes)

Secondary Outcomes (6)

• Mean Duration of Induction (in Seconds)

  From start of induction up to 15 minutes

• Percentage of Participants With Mallampati Score III and IV

  Screening

• Mean Duration of Intubation Procedure (in Minutes)

  Start of intubation to completion of intubation (up to 15 minutes)

• Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure

  Start of intubation to completion of intubation (up to 15 minutes)

• Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane

  From start of induction to completion of intubation (up to 30 minutes)

Study Arms (1)

Difficult to Intubate (DTI) Participants

Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitals with operation theaters

You may qualify if:

• \. Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent and with Mallampati score III or IV
• \. Patients with at least one of the below criteria:
• Anatomic
• micrognathia - small mandible
• macroglossia - large tongue
• short or fixed neck
• anterior vocal cords
• Trauma - neck or face
• Burns - airway edema
• Infections - edema
• Retropharyngeal abscess
• Submandibular abscess
• epiglottitis
• laryngotracheobronchitis (croup)
• Neoplasms; e.g., laryngeal tumors

You may not qualify if:

• Patients with present use of opioids and/or narcotic dependent.
• Patients with known sensitivity to sevoflurane or to other halogenated agents.
• Patients with known or suspected genetic susceptibility to malignant hyperthermia.
• Alcohol addictive patients.
• Patients with Renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL)
• Patient is a pregnant or breastfeeding female

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Amr Alaa

  AbbVie Egypt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 1, 2016
• Results First Posted: March 1, 2016

Record last verified: 2016-02