Shaping Anesthetic Techniques to Reduce Post-operative Delirium

NCT03133845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2020-06-18

No results posted yet for this study

Summary

The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults.

Conditions

  • Delirium
  • Lumbar Radiculopathy
  • Lumbar Osteoarthritis
  • Lumbar Spine Disc Degeneration

Interventions

PROCEDURE

Light sedation with propofol

Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.

PROCEDURE

Induction with propofol

Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.

PROCEDURE

Maintenance anesthetic using a volatile anesthetic

Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.

PROCEDURE

Muscle relaxant during maintenance anesthesia

Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.

PROCEDURE

Pain control with fentanyl

Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.

PROCEDURE

Bispectral Index (BIS) monitoring for depth of anesthesia

All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.

PROCEDURE

Spinal Anesthesia

Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.

PROCEDURE

Midazolam administered during spinal anesthesia

Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.

PROCEDURE

Cerebrospinal fluid collection

8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.

PROCEDURE

Administration of intrathecal morphine

Patient may receive intrathecal morphine for post-operative pain control.

Sponsors & Collaborators

Principal Investigators

  • Charles C Edwards, MD · Mercy Hospital of Baltimore

  • Charles Brown, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-05-25
Completion
2020-05-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03133845 on ClinicalTrials.gov