Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06123637
Collaborator
(none)
68
2
11.9

Study Details

Study Description

Brief Summary

The primary purpose of this study is to compare the analgesia nociception index-guided anesthesia and standard anesthesia on remifentanil requirement in desflurane anesthesia.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Analgesia nociception index-guided anesthesia
  • Behavioral: Standard anesthesia
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of Analgesia Nociception Index-guided Anesthesia and Standard Anesthesia on Remifentanil Requirement in Desflurane Anesthesia
Anticipated Study Start Date :
Jan 2, 2024
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Analgesia nociception index group

Behavioral: Analgesia nociception index-guided anesthesia
Maintaining the blood pressure based on analgesia nociception index of >50 value

Placebo Comparator: Standard group

Behavioral: Standard anesthesia
Maintaining the blood pressure based on anesthesiologist's decision

Outcome Measures

Primary Outcome Measures

  1. Remifentanil requirement [at time of the end of skin suture (up to 4 hours)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical diagnosis of gastric cancer
Exclusion Criteria:
  • Conversion to open laparotomy

  • Prior opioid abuse

  • Prior infection

  • 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:
NCT06123637
Other Study ID Numbers:
  • AJOUIRB-IV-2023-389
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2023