NCT06123624

Brief Summary

The primary purpose of this study is to compare the desflurane and sevoflurane on remifentanil requirement using analgesia nociception index-guided anesthesia in patients undergoing spine surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

November 1, 2023

Last Update Submit

November 7, 2023

Conditions

Spinal Diseases

Outcome Measures

Primary Outcomes (1)

  • remifentanil requirement

    assessing the total dose of remifentanil administered from skin incision until skin suture

    at time of the end of skin suture (up to 3 hours)

Study Arms (2)

Desflurane group

EXPERIMENTAL
Drug: Desflurane Inhalation Solution

Sevoflurane group

PLACEBO COMPARATOR
Drug: Sevoflurane Inhalation Solution

Interventions

Desflurane Inhalation SolutionDRUG

Keeping the anesthesia using desflurane inhalation solution as 1 minimal alveolar concentration

Desflurane group
Sevoflurane Inhalation SolutionDRUG

Keeping the anesthesia using sevoflurane inhalation solution as 1 minimal alveolar concentration

Sevoflurane group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of herniated disc, injury of spinal cord, and neoplasm of spinal meninges

You may not qualify if:

  • Hyperbilirubinemia
  • Prior chronic pain
  • Prior opioid abuse
  • Cardiac arrythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 9, 2023

Study Start

November 27, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11