Early Cognitive Function in Elderly Patients After Laser Laryngeal Surgery: Des vs Prop

NCT03194074 | Unknown Phase 4

• 1 other identifier: POCD-DesProp
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative cognitive impairment is one of the most common complications in elderly surgical patients. Laser laryngeal surgery is a short procedure, but characterized by high risk of disastrous airway fire. So the recommended oxygen concentration is less than 30%. For elderly patients, because of preoperatively declined cardiovascular and lung function and cognitive function, there is a potential that intraoperative low oxygen concentration may lead to drop of arterial oxygen tension, decrease of brain oxygenation, and exacerbate brain function impairment. Intravenous anesthesia and inhalation anesthesia is two commonly used technique for general anesthesia. Consequently, we carry out this study to identify whether different classes of anesthetics can affect postoperative cognitive function in old patient undergoing laser laryngeal surgery.

Conditions

Cognition Disorders in Old Age

Keywords

Laser Laryngeal Surgery; Desflurane; Propofol

Outcome Measures

Primary Outcomes (1)

• Change of Mini-Mental State (MMS) test score

  Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery

  Change of MMS score between two time points (the day before surgery and 30min postoperatively

Secondary Outcomes (3)

• Change of Mini-Mental State (MMS) test score

  Change of MMS score between two time points (the day before surgery and 1h postoperatively

• Change of Mini-Mental State (MMS) test score

  Change of MMS score between two time points (the day before surgery and 3h postoperatively

• Change of Mini-Mental State (MMS) test score

  Change of MMS score between two time points (the day before surgery and 24h postoperatively

Study Arms (2)

propofol group

EXPERIMENTAL

Propofol/remifentanil-based general anesthesia.

Drug: Propofol

desflurane group

EXPERIMENTAL

Desflurane/remifentanil-based general anesthesia.

Drug: Desflurane

Interventions

Propofol DRUG

In propofol/remifentanil group, propofol at a rate 75\~150 µg/kg/min and remifentanil at 0.1-0.3 µg/kg/min are maintained throughout surgery.

Also known as: Propofol injection from AstraZeneca

propofol group

Desflurane DRUG

In desflurane/remifentanil group, desflurane at end tidal concentration at 0.7\~1.0 minimum alveolar concentration (MAC) and remifentanil 0.1-0.3 ug/kg/min are used.

Also known as: Suprane from Baxter

desflurane group

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for laser laryngeal surgery under general anesthesia with either Propofol or desflurane based technique.

You may not qualify if:

• Patients with cardiac, pulmonary, hepatic, or renal dysfunction, epilepsy, or uncontrolled hypertension, or those taking medications that influence the central nervous system, are excluded from the study. Patients who show obvious alteration of mental status, or refuse to participate, are also excluded from the study.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (4)

• Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7.

  PMID: 21474666 BACKGROUND

• Larsen B, Seitz A, Larsen R. Recovery of cognitive function after remifentanil-propofol anesthesia: a comparison with desflurane and sevoflurane anesthesia. Anesth Analg. 2000 Jan;90(1):168-74. doi: 10.1097/00000539-200001000-00035.

  PMID: 10624999 BACKGROUND

• Royse CF, Andrews DT, Newman SN, Stygall J, Williams Z, Pang J, Royse AG. The influence of propofol or desflurane on postoperative cognitive dysfunction in patients undergoing coronary artery bypass surgery. Anaesthesia. 2011 Jun;66(6):455-64. doi: 10.1111/j.1365-2044.2011.06704.x. Epub 2011 Apr 18.

  PMID: 21501129 BACKGROUND

• Roy S, Smith LP. Surgical fires in laser laryngeal surgery: are we safe enough? Otolaryngol Head Neck Surg. 2015 Jan;152(1):67-72. doi: 10.1177/0194599814555853. Epub 2014 Oct 24.

  PMID: 25344591 BACKGROUND

MeSH Terms

Interventions

Propofol; Desflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Xia Shen, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Shen, M.D.

CONTACT

8613611874118; zlsx@yahoo.com

Hui Qiao, M.D.

CONTACT

8615900598163; theyellow@163.com

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: Vise Director of Department of Anesthesiology

Study Record Dates

• First Submitted: June 17, 2017
• First Posted: June 21, 2017
• Study Start: August 15, 2017
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)