Desflurane and Sevoflurane on Remifentanil Requirement

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06123624

Collaborator

(none)

Enrollment

Arms

9.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Diseases	Drug: Desflurane Inhalation Solution Drug: Sevoflurane Inhalation Solution	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Comparison of Desflurane and Sevoflurane on Remifentanil Requirement Using Analgesia Nociception Index-guided Anesthesia

Anticipated Study Start Date :

Nov 27, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desflurane group	Drug: Desflurane Inhalation Solution Keeping the anesthesia using desflurane inhalation solution as 1 minimal alveolar concentration
Placebo Comparator: Sevoflurane group	Drug: Sevoflurane Inhalation Solution Keeping the anesthesia using sevoflurane inhalation solution as 1 minimal alveolar concentration

Arm

Intervention/Treatment

Experimental: Desflurane group

Drug: Desflurane Inhalation Solution

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

Placebo Comparator: Sevoflurane group

Drug: Sevoflurane Inhalation Solution

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

Outcome Measures

Primary Outcome Measures

remifentanil requirement [at time of the end of skin suture (up to 3 hours)]
assessing the total dose of remifentanil administered from skin incision until skin suture

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Hyperbilirubinemia
Prior chronic pain
Prior opioid abuse
Cardiac arrythmia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji Eun Kim, Assistant professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT06123624

Other Study ID Numbers:

AJOUIRB-IV-2023-380

First Posted:

Nov 9, 2023

Last Update Posted:

Nov 9, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Diseases

Sevoflurane

Desflurane

Pharmaceutical Solutions

Study Results

No Results Posted as of Nov 9, 2023