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

Pulmonary Aspiration Clinical Trial

Official title:

To Compare Effect of Sevoflurane Versus Desflurane on the Return of Protective Airway Reflexes in the Elderly Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833676
• Other study ID #: 901.11
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2013
• Last updated: December 4, 2013
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2013
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, double-blind, randomized controlled trial by single operator. American Society of Anaesthesiologists' classification of physical status I-II male and female patients aged 60-85 year scheduled to have general anesthesia for surgical procedures were recruited. Patients recruited will be given 20mls of water to swallow in the upright position prior to surgery after obtaining informed consent. All patients enrolled are judged to have adequate swallowing if no coughing or drooling occurred after the water passed into the mouth, and no water remained in the oropharynx upon subsequent visual inspection.

The anaesthetist in charge of the patients enrolled in the study will be given a sealed envelope containing the name of the randomised gas to be used for the patient. At the end of surgery, an observer who is blinded to the anaesthethic allocation will record the relevant data. The blinded observer determined the time to first appropriate response to command (asking the patient to 'open his/her eyes' or squeezing the observer's hand, state his/her name or state date of birth) every 30s after discontinuation of anesthetic administration and removal of LMA. Exactly 5 minutes after appropriate verbal response, patient was asked to swallow 20mls of water in a 30 degree upright position. Successful swallowing is defined as ingestion of the 20mls of water without coughing or drooling. If swallowing was successful, the study was concluded. If it was unsuccessful, the patient was asked to swallow at 5, 10, 15, 20, 25 and 30 minutes, with termination of participation after successful swallowing. A stopwatch will be used to time the duration to recovery.

A study sample size of 60 is selected, with a power of 0.80 taken as the standard of adequacy. A p-value of < 0.05 is taken as the criteria for the test result to be statistically significant and data will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Aspiration

Intervention

Drug:
• Sevoflurane

• Desflurane

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

McKay RE, Large MJ, Balea MC, McKay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Emergence and immediate recovery times after discontinuation of sevoflurane versus desflurane	Emergence and immediate recovery times are the time taken by patient to open eyes to call or grip the observer's hands, and obey simple commands ie state his/her name or state his/her date of birth. A Stopwatch is used to record the time from discontinuation of the anaesthetic agent used to the emergence and immediate recovery times	A stopwatch will be used to record the time (in minutes) of patient obeying verbal command	No