To Compare Effect of Sevoflurane Versus Desflurane on the Return of Swallowing Reflexes in the Elderly

NCT01833676 | Completed Phase 4

• 1 other identifier: 901.11
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Anaesthesia and surgery has become more common in the elderly as the population survives longer. Anaesthesia in the elderly confers a higher risk which is related to the aging process and the diseases that accompany seniority. As such, there is a need to provide optimal anaesthetic management in order to minimize complications and risks perioperatively. One of the changes associated with ageing is the progressive decrease in protective laryngeal reflexes. Any depression of upper airway reflexes increases the chance of pulmonary aspiration and compromises the maintenance of the airway. Desflurane is an inhalational agent strongly favored due to its lower solubility in blood, lean tissue and fat as compared to sevoflurane. This enables the agent to be quickly eliminated at the end of surgery, with minimal metabolic breakdown, thus facilitating more rapid emergence as compared to sevoflurane anesthesia in elderly undergoing general anaesthesia. McKay et al conducted a study in 2005 in US, which showed that the choice of inhalational agent itself can influence the return of protective airway reflexes. In the study, the inhalational agent sevoflurane was found to cause significant impairment of swallowing, in comparison with desflurane(1). However, the aforementioned study focussed on the general population. As such, the purpose of this study is to determine whether the choice of inhalational anesthetic (sevoflurane versus desflurane) has similar influence on the return of protective airway reflexes in the geriatric population in Malaysia, and whether the significance is greater in the elderly population.

Conditions

Pulmonary Aspiration

Keywords

sevoflurane; desflurane; protective airway reflexes; elderly

Outcome Measures

Primary Outcomes (1)

• The recovery of ability to swallow 20mls of water at designated time frame after response to command

  Patient is asked to swallow 20mls of water every 5 minutes after appropriate verbal response. Successful swallowing is defined as swallowing 20mls of water without drooling, coughing, choking or nausea. If patient fails to swallow at the first 5 minutes, the test will be repeated every 5 minutes until 30 minutes are up or until patient is able to swallow successfully

  up to 30 minutes after appropriate verbal response

Secondary Outcomes (1)

• Emergence and immediate recovery times after discontinuation of sevoflurane versus desflurane

  A stopwatch will be used to record the time (in minutes) of patient obeying verbal command

Study Arms (2)

Desflurane

ACTIVE COMPARATOR

Patient receiving Desflurane for maintenance of general anaesthesia

Drug: Desflurane

Sevoflurane

ACTIVE COMPARATOR

Patient receiving Sevoflurane for maintenance of general anaesthesia

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

Also known as: Sevorane

Sevoflurane

Desflurane DRUG

Desflurane

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60-85 years' old
• Both male and female patients
• ASA I-II
• Body mass index (BMI) ≤ 30 kg/m2
• Elective surgery under general anaesthesia with the use of laryngeal mask airway (LMA) / LMA Proseal / LMA Supreme
• Type of surgery: Urogynecological, General Surgery, Orthopedics, Eye, Vascular, Plastic
• Surgery/anaesthesia lasting for 0.5-3 hours

You may not qualify if:

• Patients with difficulty in swallowing, preexisting neuromuscular or central nervous system disorder
• Patients undergoing intra abdominal, thoracic, face, nasal or throat surgery
• Known condition interfering with gastric emptying
• Patients with cognitive or hearing impairment and inability to provide informed consent
• ASA III-IV patients
• Use of muscle relaxant during the course of general anesthesia
• Contraindication or previous adverse response to any of the study drugs

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (1)

• Mckay RE, Large MJC, Balea MC, Mckay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700. doi: 10.1213/01.ANE.0000146514.65070.AE.

  PMID: 15728054 BACKGROUND

MeSH Terms

Interventions

Sevoflurane; Desflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Study Officials

• Lee Fenky, MBBS (IMU)

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 6, 2013
• First Posted: April 17, 2013
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

MY (1)