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Neuraxial Anesthesia for Surgery

N/A

Recruiting

Led By Daniel McIsaac, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will first look at how well they can recruit, get participants to follow instructions, and keep in touch with them for lower limb surgery. This will help them plan a bigger study in the future

Who is the study for?

The ALOFT Pilot Trial is for adults over 18 who are scheduled for lower limb revascularization surgery, like arterial bypass or angioplasty. Participants need to be able to use a phone for follow-up. It's not specified who can't join the trial.

What is being tested?

This pilot study tests neuraxial anesthesia against general anesthesia in surgeries for Peripheral Arterial Disease. It aims to assess recruitment, adherence, and follow-up processes needed for a larger future trial on anesthesia effectiveness.

What are the potential side effects?

While specific side effects aren't listed here, generally neuraxial anesthesia may cause low blood pressure, headache, backache or difficulty urinating; general anesthesia might lead to nausea, vomiting, sore throat and confusion post-surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Monthly recruitment

Secondary study objectives

Elicitation of patient, clinician and researcher-identified barriers and facilitators

Intervention adherence

Retention

Other study objectives

Complications

Days at home

Delirium

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Intervention arm participants will be allocated to neuraxial anesthesia. The specific approach (spinal, epidural, or combined spinal and epidural) will be at the discretion of the treating anesthesiologist, as the underlying physiologic mechanisms and impacts are similar for both approaches. Allowing clinician discretion will reflect routine standard of care practice and support generalizability. Specific choice of neuraxial anesthetic medications, doses, and adjuncts will also be at the discretion of the attending anesthesiologist, supporting pragmatism. While existing randomized data do not suggest that the sedation level during neuraxial anesthesia leads to differences in outcomes, providers will be requested to maintain sedation at or below a 3 on the Observer's Assessment of Alertness/Sedation scale (OAAS; mild to moderate sedation consistent to responding to verbal stimuli), the same approach used in a recent large pragmatic trial of anesthesia in hip fracture patients.

Group II: ControlActive Control1 Intervention

Control group participants will be allocated to general anesthesia. Choice of anesthetic medications and doses will be at the discretion of each anesthesiologist as per routine standard of care, again supporting conduct of a pragmatic and generalizable trial. Similarly, choice of airway management strategies and anesthetic depth will also be based on patient and provider preference, as a recent large randomized trial demonstrates that anesthetic depth is not causally linked to risk of morbidity or mortality after surgery. Details of general anesthesia management and medications will be collected for all patients.

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