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Phase 4 N=67 Randomized Double-blind Treatment

Using the SEDLine for the Titration of Sevoflurane in Elderly Patients Recovery Using the SEDLine TM for the Titration of Sevoflurane in Elderly Patients Undergoing Non-Cardiac Surgery After Beta-Adrenergic Blockade

Anesthesia, General

Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Time to Extubation — 13.0; 12.5 minutes

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Sedline (Device)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Jun 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to Extubation
13.0; 12.5

Summary

Asses the effect of the use of Patient State Index (PSI) monitoring on difference in emergence profiles in the elderly (age >65 yrs) population to develop a cost-benefit profile. Assess differences in Quality of Life using the QoR-40 (a validated 40-item questionnaire on quality of recovery from anesthesia) between the two treatment groups.

Eligibility Criteria

Inclusion Criteria

  • Patient is male or female.
  • Patient is 65 years of age or older.
  • Patient has a physical status between ASA I and III. (Appendix C).
  • Patient scheduled for general anesthesia for non-cardiac surgery expected to last at least one hour.
  • Patient able to communicate in English.
  • Patient has signed an approved informed consent.

Exclusion Criteria

  • Patient's age is less than 65 years
  • Anesthetic duration of less than one hour expected
  • Treatment of beta blockers contra-indicated
  • Not a candidate for general anesthesia
  • Patient requires regional anesthesia with general anesthesia.
  • ASA physical status of IV or V. (Appendix C)
  • Patient has known drug or alcohol abuse.
  • Patient has scalp or skull abnormalities such as psoriasis, eczema, angioma, scar tissue, burr holes, cranial implants (such as plates, shunts, etc.).
  • Patient has experienced a head injury with loss of consciousness within the last year.
  • Patient has known neurological and psychiatric disorder that interferes with the patient's level of consciousness.
  • Known concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, SSRIs, neuroleptics, anxiolytics or antipsychotics).
  • Patient has any medical condition which, in the judgment of the investigator, renders them inappropriate for participation in this study, such as Guillen Bare syndrome
  • Known hypersensitivity to the intended anesthetic agents including significant post-operative nausea or vomiting.
  • Uncontrolled hypertension (unresponsive to medication): Systolic BP > 180 mmHg or Diastolic BP > 105 mmHg
  • Pre-Op baseline heart rate < 45 beats per minute
  • Weight 50% greater than ideal body weight
  • Already monitored for EP or EEG, i.e., Spinal cord cases
  • Actual anesthetic duration < 1 hour (assessed after emergence).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00938782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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